Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function (BalanceD-HF)

April 24, 2026 updated by: AstraZeneca

A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function

This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

Study Overview

Status

Recruiting

Conditions

Heart Failure and Impaired Kidney Function

Intervention / Treatment

Detailed Description

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event.

Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:

Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule

The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin.

The study will be conducted at approximately 700 sites in approximately 40 countries globally.

Study Type

Interventional

Enrollment (Estimated)

4800

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1056ABJ
    - Recruiting
    - Research Site
  - Buenos Aires, Argentina, C1180AAX
    - Recruiting
    - Research Site
  - Buenos Aires, Argentina, 1416
    - Recruiting
    - Research Site
  - CABA, Argentina, C1425AGC
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1419AHL
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1425DES
    - Recruiting
    - Research Site
  - Corrientes, Argentina, W3400CDS
    - Recruiting
    - Research Site
  - Córdoba, Argentina, X5003DCE
    - Recruiting
    - Research Site
  - Córdoba, Argentina, X5006CBI
    - Recruiting
    - Research Site
  - Esperanza, Argentina, S3080BQU
    - Recruiting
    - Research Site
  - Granadero Baigorria, Argentina, S2152BOF
    - Recruiting
    - Research Site
  - Mar del Plata, Argentina, B7600GNY
    - Recruiting
    - Research Site
  - Rosario, Argentina, 2123
    - Recruiting
    - Research Site
  - San Juan Bautista, Argentina, 1888
    - Recruiting
    - Research Site
  - San Miguel de Tucumán, Argentina, 4000
    - Recruiting
    - Research Site
  - San Miguel de Tucumán, Argentina, 4000
    - Withdrawn
    - Research Site
  - San Miguel de Tucumán, Argentina, T4000ICL
    - Recruiting
    - Research Site
  - Santa Fe, Argentina, S3000FWO
    - Recruiting
    - Research Site
Australia
- - Blacktown, Australia, 2148
    - Recruiting
    - Research Site
  - Cairns, Australia, 4870
    - Withdrawn
    - Research Site
  - Canberra, Australia, 2605
    - Recruiting
    - Research Site
  - Chermside, Australia, 4032
    - Withdrawn
    - Research Site
  - Clayton, Australia, 3168
    - Recruiting
    - Research Site
  - Concord, Australia, 2139
    - Recruiting
    - Research Site
  - Frankston, Australia, 3199
    - Recruiting
    - Research Site
  - Geelong, Australia, 3220
    - Recruiting
    - Research Site
  - Murdoch, Australia, WA6150
    - Recruiting
    - Research Site
  - North Tamworth, Australia, 2340
    - Recruiting
    - Research Site
  - Westmead, Australia, 2145
    - Not yet recruiting
    - Research Site
Austria
- - Bad Ischl, Austria, 4820
    - Recruiting
    - Research Site
  - Braunau am Inn, Austria, 5280
    - Recruiting
    - Research Site
  - Graz, Austria, 8036
    - Recruiting
    - Research Site
  - Linz, Austria, 4020
    - Recruiting
    - Research Site
  - Saint Stefan/Stainz, Austria, 8511
    - Recruiting
    - Research Site
  - Salzburg, Austria, 5020
    - Recruiting
    - Research Site
  - Sankt Pölten, Austria, 3100
    - Recruiting
    - Research Site
  - Vienna, Austria, 1090
    - Recruiting
    - Research Site
  - Vienna, Austria, 1100
    - Recruiting
    - Research Site
  - Vienna, Austria, 1160
    - Recruiting
    - Research Site
  - Vöcklabruck, Austria, 4840
    - Not yet recruiting
    - Research Site
Brazil
- - Aracaju, Brazil, 49015-380
    - Recruiting
    - Research Site
  - Blumenau, Brazil, 89020-430
    - Recruiting
    - Research Site
  - Brasília, Brazil, 70200-730
    - Recruiting
    - Research Site
  - Campina Grande do Sul, Brazil, 83.430-000
    - Recruiting
    - Research Site
  - Campinas, Brazil, 13060-080
    - Recruiting
    - Research Site
  - Curitiba, Brazil, 80730-150
    - Recruiting
    - Research Site
  - Goiânia, Brazil, 74605-020
    - Recruiting
    - Research Site
  - Niterói, Brazil, 24033-900
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-903
    - Recruiting
    - Research Site
  - Rio Branco, Brazil, 69915-030
    - Not yet recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 20241-180
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 22061-080
    - Withdrawn
    - Research Site
  - Rio de Janeiro, Brazil, 20551-030
    - Recruiting
    - Research Site
  - São José dos Campos, Brazil, 12230-001
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 05403-000
    - Withdrawn
    - Research Site
  - São Paulo, Brazil, 04012-180
    - Suspended
    - Research Site
  - Teresina, Brazil, 64049-550
    - Recruiting
    - Research Site
  - Uberlândia, Brazil, 38400-500
    - Recruiting
    - Research Site
Bulgaria
- - Botevgrad, Bulgaria, 2140
    - Recruiting
    - Research Site
  - Dupnitsa, Bulgaria, 2600
    - Recruiting
    - Research Site
  - Haskovo, Bulgaria, 6300
    - Recruiting
    - Research Site
  - Kozloduy, Bulgaria, 3320
    - Withdrawn
    - Research Site
  - Pleven, Bulgaria, 5800
    - Recruiting
    - Research Site
  - Plovdiv, Bulgaria, 4003
    - Recruiting
    - Research Site
  - Plovdiv, Bulgaria, 4000
    - Recruiting
    - Research Site
  - Sliven, Bulgaria, 8800
    - Recruiting
    - Research Site
  - Sliven, Bulgaria, 8800
    - Withdrawn
    - Research Site
  - Sofia, Bulgaria, 1000
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1606
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1756
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1431
    - Withdrawn
    - Research Site
  - Sofia, Bulgaria, 1309
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1618
    - Recruiting
    - Research Site
  - Stara Zagora, Bulgaria, 6000
    - Recruiting
    - Research Site
Canada
- British Columbia
  - New Westminster, British Columbia, Canada, V3L 3W4
    - Withdrawn
    - Research Site
  - North Vancouver, British Columbia, Canada, V7M 2H4
    - Withdrawn
    - Research Site
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - Withdrawn
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - Recruiting
    - Research Site
- Nova Scotia
  - Sydney, Nova Scotia, Canada, B1P 1P3
    - Recruiting
    - Research Site
- Ontario
  - Cambridge, Ontario, Canada, N1R 7R1
    - Recruiting
    - Research Site
  - Cambridge, Ontario, Canada, N1R 6V6
    - Completed
    - Research Site
  - Hamilton, Ontario, Canada, L8L 5G4
    - Recruiting
    - Research Site
  - London, Ontario, Canada, N6A 5A5
    - Recruiting
    - Research Site
  - Newmarket, Ontario, Canada, L3Y 2P6
    - Recruiting
    - Research Site
  - North York, Ontario, Canada, M6B 3H7
    - Recruiting
    - Research Site
  - Oakville, Ontario, Canada, L6K 3W7
    - Withdrawn
    - Research Site
  - Oshawa, Ontario, Canada, L1J 2K1
    - Terminated
    - Research Site
  - Ottawa, Ontario, Canada, K1Y 4W7
    - Withdrawn
    - Research Site
  - Peterborough, Ontario, Canada, K9J 0B2
    - Withdrawn
    - Research Site
  - Thunder Bay, Ontario, Canada, P7B 7C7
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M6G 1M2
    - Recruiting
    - Research Site
  - Waterloo, Ontario, Canada, N2T 0C1
    - Recruiting
    - Research Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 7K9
    - Withdrawn
    - Research Site
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H4J 1C5
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H1T 1C8
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H2X 0C1
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H3G 1A4
    - Withdrawn
    - Research Site
  - Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
    - Recruiting
    - Research Site
  - Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2
    - Withdrawn
    - Research Site
  - Trois-Rivières, Quebec, Canada, G9A 4P3
    - Recruiting
    - Research Site
Chile
- - Antofagasta, Chile, 1240000
    - Withdrawn
    - Research Site
  - Punta Arenas, Chile, 6200000
    - Withdrawn
    - Research Site
  - Region Metropolitana, Chile, 7550000
    - Recruiting
    - Research Site
  - San Bernardo, Chile, 8070996
    - Recruiting
    - Research Site
  - Santiago, Chile, 8380453
    - Recruiting
    - Research Site
  - Santiago, Chile, 8910259
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500922
    - Terminated
    - Research Site
  - Santiago, Chile, 7500587
    - Withdrawn
    - Research Site
  - Santiago, Chile, 7770086
    - Withdrawn
    - Research Site
  - Santiago, Chile, 8330034
    - Terminated
    - Research Site
  - Talcahuano, Chile, 4270918
    - Not yet recruiting
    - Research Site
  - Temuco, Chile, 4810345
    - Recruiting
    - Research Site
  - Temuco, Chile, 4781156
    - Withdrawn
    - Research Site
  - Valdivia, Chile, 5110683
    - Recruiting
    - Research Site
  - Victoria, Chile, 4720097
    - Recruiting
    - Research Site
China
- - Baotou, China, 14010
    - Recruiting
    - Research Site
  - Beijing, China, 100029
    - Withdrawn
    - Research Site
  - Beijing, China, 100730
    - Recruiting
    - Research Site
  - Beijing, China, 100034
    - Recruiting
    - Research Site
  - Beijing, China, 100037
    - Recruiting
    - Research Site
  - Beijing, China, 100029
    - Terminated
    - Research Site
  - Changchun, China, 130033
    - Recruiting
    - Research Site
  - Changsha, China, 430033
    - Recruiting
    - Research Site
  - Changsha, China, 410015
    - Recruiting
    - Research Site
  - Chengdu, China, 610041
    - Recruiting
    - Research Site
  - Chengdu, China, 610072
    - Recruiting
    - Research Site
  - Chifeng, China, 024000
    - Recruiting
    - Research Site
  - Chongqing, China, 404197
    - Recruiting
    - Research Site
  - Guangzhou, China, 510630
    - Recruiting
    - Research Site
  - Guangzhou, China, 510515
    - Recruiting
    - Research Site
  - Guangzhou, China, 510100
    - Recruiting
    - Research Site
  - Hangzhou, China, 310014
    - Recruiting
    - Research Site
  - Harbin, China, 150001
    - Recruiting
    - Research Site
  - Hengyang, China, 421001
    - Recruiting
    - Research Site
  - Heze, China, 274099
    - Recruiting
    - Research Site
  - Hohhot, China, 010017
    - Withdrawn
    - Research Site
  - Jinan, China, 250013
    - Recruiting
    - Research Site
  - Jining, China, 272029
    - Recruiting
    - Research Site
  - Lanzhou, China, 730030
    - Recruiting
    - Research Site
  - Liaocheng, China, 252000
    - Recruiting
    - Research Site
  - Linhai, China, 317000
    - Recruiting
    - Research Site
  - Nanchang, China, 330009
    - Recruiting
    - Research Site
  - Nanchong, China, 637900
    - Completed
    - Research Site
  - Nanjing, China, 210009
    - Recruiting
    - Research Site
  - Nanjing, China, 2100008
    - Recruiting
    - Research Site
  - Nanjing, China, 210029
    - Recruiting
    - Research Site
  - Nanjing, China, 210011
    - Recruiting
    - Research Site
  - Ningbo, China, 315040
    - Recruiting
    - Research Site
  - Pingxiang, China, 337055
    - Recruiting
    - Research Site
  - Quzhou, China, 342000
    - Recruiting
    - Research Site
  - Sanya, China, 572000
    - Recruiting
    - Research Site
  - Shanghai, China, 200025
    - Recruiting
    - Research Site
  - Shanghai, China, 200062
    - Recruiting
    - Research Site
  - Shenyang, China, 110004
    - Recruiting
    - Research Site
  - Shenzhen, China, 518053
    - Recruiting
    - Research Site
  - Wuhan, China, 430030
    - Withdrawn
    - Research Site
  - Wuhan, China, 430022
    - Withdrawn
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Xi'an, China, 710068
    - Recruiting
    - Research Site
  - Xianyang, China, 750004
    - Withdrawn
    - Research Site
  - Xuzhou, China, 221000
    - Recruiting
    - Research Site
  - Xuzhou, China, 221009
    - Recruiting
    - Research Site
  - Yangzhou, China, 225001
    - Recruiting
    - Research Site
  - Zhangjiakou, China, 075061
    - Recruiting
    - Research Site
  - Zunyi, China, 563100
    - Recruiting
    - Research Site
  - Ürümqi, China, CN-830004
    - Recruiting
    - Research Site
Colombia
- - Armenia, Colombia, 630004
    - Recruiting
    - Research Site
  - Barranquilla, Colombia, 80007
    - Recruiting
    - Research Site
  - Barranquilla, Colombia, 080020
    - Recruiting
    - Research Site
  - Bogotá, Colombia, 111211
    - Recruiting
    - Research Site
  - Bogotá, Colombia, 110221
    - Completed
    - Research Site
  - Cali, Colombia, 760036
    - Recruiting
    - Research Site
  - Cali, Colombia, 760032
    - Recruiting
    - Research Site
  - Manizales, Colombia, 170004
    - Recruiting
    - Research Site
  - Medellín, Colombia, 050034
    - Recruiting
    - Research Site
  - Medellín, Colombia, 050030
    - Recruiting
    - Research Site
  - Piedecuesta, Colombia, 681017
    - Recruiting
    - Research Site
  - Rionegro, Colombia, 054047
    - Recruiting
    - Research Site
Czechia
- - Brno, Czechia, 60200
    - Recruiting
    - Research Site
  - Brno, Czechia, 639 00
    - Terminated
    - Research Site
  - Broumov, Czechia, 55001
    - Recruiting
    - Research Site
  - Jaroměř, Czechia, 551 01
    - Recruiting
    - Research Site
  - Louny, Czechia, 440 01
    - Recruiting
    - Research Site
  - Ostrava, Czechia, 702 00
    - Recruiting
    - Research Site
  - Ostrava, Czechia, 702 00
    - Suspended
    - Research Site
  - Pilsen, Czechia, 31001
    - Withdrawn
    - Research Site
  - Plzen - Bory, Czechia, 305 99
    - Recruiting
    - Research Site
  - Prague, Czechia, 120 00
    - Terminated
    - Research Site
  - Přerov, Czechia, 75152
    - Recruiting
    - Research Site
  - Slaný, Czechia, 274 01
    - Recruiting
    - Research Site
  - Svitavy, Czechia, 568 02
    - Recruiting
    - Research Site
  - Ustí Nad Labem, Czechia, 40011
    - Withdrawn
    - Research Site
  - Zlín, Czechia, 760 01
    - Recruiting
    - Research Site
  - Ústí nad Labem, Czechia, 400 01
    - Recruiting
    - Research Site
  - Česká Lípa, Czechia, 470 77
    - Recruiting
    - Research Site
Finland
- - Helsinki, Finland, 00290
    - Recruiting
    - Research Site
  - Tampere, Finland, 33520
    - Recruiting
    - Research Site
  - Turku, Finland, 20520
    - Recruiting
    - Research Site
France
- - Bron, France, 69667
    - Withdrawn
    - Research Site
  - Béziers, France, 34500
    - Recruiting
    - Research Site
  - Caen, France, 14033
    - Withdrawn
    - Research Site
  - Cholet, France, 49300
    - Recruiting
    - Research Site
  - Créteil, France, 94010
    - Recruiting
    - Research Site
  - Dijon, France, 21079
    - Recruiting
    - Research Site
  - La Roche-sur-Yon, France, 85925
    - Recruiting
    - Research Site
  - La Tronche, France, 38043
    - Withdrawn
    - Research Site
  - Le Coudray, France, 28630
    - Withdrawn
    - Research Site
  - Limoges, France, 87000
    - Recruiting
    - Research Site
  - Meaux, France, 77104
    - Recruiting
    - Research Site
  - Montauban, France, 82017
    - Withdrawn
    - Research Site
  - Montpellier, France, 34000
    - Recruiting
    - Research Site
  - Montpellier, France, 34295
    - Recruiting
    - Research Site
  - Nantes, France, 44093
    - Recruiting
    - Research Site
  - Orléans, France, 45100
    - Withdrawn
    - Research Site
  - Paris, France, 75010
    - Recruiting
    - Research Site
  - Paris, France, 75015
    - Recruiting
    - Research Site
  - Poitiers, France, 86021
    - Recruiting
    - Research Site
  - Reims, France, 51092
    - Recruiting
    - Research Site
  - Rennes, France, 35033
    - Recruiting
    - Research Site
  - Rouen, France, 76031
    - Recruiting
    - Research Site
  - Saint-Quentin, France, 02100
    - Recruiting
    - Research Site
  - Strasbourg, France, 67091
    - Withdrawn
    - Research Site
  - Toulon, France, 83100
    - Recruiting
    - Research Site
  - Toulouse, France, 31059
    - Recruiting
    - Research Site
  - Tours, France, 37044
    - Withdrawn
    - Research Site
  - Valenciennes, France, 59300
    - Recruiting
    - Research Site
Germany
- - Bad Nauheim, Germany, 61231
    - Suspended
    - Research Site
  - Bechhofen, Germany, 66894
    - Withdrawn
    - Research Site
  - Berlin, Germany, 12203
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 13405
    - Recruiting
    - Research Site
  - Bernau bei Berlin, Germany, 16321
    - Suspended
    - Research Site
  - Chemnitz, Germany, 9113
    - Withdrawn
    - Research Site
  - Coburg, Germany, 96450
    - Recruiting
    - Research Site
  - Dresden, Germany, 1307
    - Recruiting
    - Research Site
  - Dresden, Germany, 01099
    - Withdrawn
    - Research Site
  - Elsterwerda, Germany, 04910
    - Suspended
    - Research Site
  - Frankfurt, Germany, 60590
    - Withdrawn
    - Research Site
  - Freiburg im Breisgau, Germany, 79106
    - Recruiting
    - Research Site
  - Goslar, Germany, 38642
    - Not yet recruiting
    - Research Site
  - Göttingen, Germany, 37075
    - Not yet recruiting
    - Research Site
  - Hagen, Germany, 58135
    - Recruiting
    - Research Site
  - Hamburg, Germany, 20246
    - Recruiting
    - Research Site
  - Hamburg, Germany, 22457
    - Withdrawn
    - Research Site
  - Hamburg, Germany, 22459
    - Withdrawn
    - Research Site
  - Heidelberg, Germany, 69120
    - Recruiting
    - Research Site
  - Kaiserslautern, Germany, 67655
    - Withdrawn
    - Research Site
  - Langen, Germany, 63225
    - Withdrawn
    - Research Site
  - Leipzig, Germany, 04103
    - Suspended
    - Research Site
  - Leverkusen, Germany, 51375
    - Withdrawn
    - Research Site
  - Mainz, Germany, 55131
    - Withdrawn
    - Research Site
  - Mainz, Germany, 55122
    - Recruiting
    - Research Site
  - Mönchengladbach, Germany, 41063
    - Suspended
    - Research Site
  - Münster, Germany, 48149
    - Withdrawn
    - Research Site
  - Paderborn, Germany, 33098
    - Withdrawn
    - Research Site
  - Papenburg, Germany, 26871
    - Recruiting
    - Research Site
  - Regensburg, Germany, 93053
    - Recruiting
    - Research Site
  - Rostock, Germany, 18059
    - Withdrawn
    - Research Site
  - Völklingen, Germany, 66333
    - Withdrawn
    - Research Site
  - Wermsdorf, Germany, 04779
    - Suspended
    - Research Site
  - Witten, Germany, 58455
    - Withdrawn
    - Research Site
Greece
- - Athens, Greece, 11528
    - Recruiting
    - Research Site
  - Athens, Greece, 12462
    - Recruiting
    - Research Site
  - Athens, Greece, 11527
    - Recruiting
    - Research Site
  - Athens, Greece, 11526
    - Recruiting
    - Research Site
  - Athens, Greece, 11521
    - Recruiting
    - Research Site
  - Athens, Greece, 14233
    - Recruiting
    - Research Site
  - Athens, Greece, 15123
    - Recruiting
    - Research Site
  - Dragana, Greece, 68100
    - Recruiting
    - Research Site
  - Heraklio, Greece, 71110
    - Completed
    - Research Site
  - Thessaloniki, Greece, 54642
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 54636
    - Recruiting
    - Research Site
Hungary
- - Balatonfüred, Hungary, 8230
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1033
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1036
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1122
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1145
    - Withdrawn
    - Research Site
  - Békéscsaba, Hungary, 5600
    - Recruiting
    - Research Site
  - Gyula, Hungary, 5700
    - Withdrawn
    - Research Site
  - Hódmezővásárhely, Hungary, 6800
    - Withdrawn
    - Research Site
  - Kecskemét, Hungary, 6000
    - Recruiting
    - Research Site
  - Orosháza, Hungary, 5900
    - Withdrawn
    - Research Site
  - Pécs, Hungary, 7635
    - Recruiting
    - Research Site
  - Pécs, Hungary, 7623
    - Recruiting
    - Research Site
  - Székesfehérvár, Hungary, 8000
    - Recruiting
    - Research Site
India
- - Ahmedabad, India, 380054
    - Withdrawn
    - Research Site
  - Ajmer, India, 305001
    - Withdrawn
    - Research Site
  - Amritsar, India, 143501
    - Not yet recruiting
    - Research Site
  - Bangalore, India, 560099
    - Recruiting
    - Research Site
  - Belagavi, India, 590010
    - Recruiting
    - Research Site
  - Coimbatore, India, 641018
    - Recruiting
    - Research Site
  - Dehradun, India, 248001
    - Recruiting
    - Research Site
  - Delhi, India, 110062
    - Recruiting
    - Research Site
  - Hyderabad, India, 500035
    - Recruiting
    - Research Site
  - Hyderabad, India, 500018
    - Withdrawn
    - Research Site
  - Hyderabad, India, 500034
    - Suspended
    - Research Site
  - Kanpur, India, 208001
    - Recruiting
    - Research Site
  - Karamsad, India, 388345
    - Withdrawn
    - Research Site
  - Kolkata, India, 700020
    - Recruiting
    - Research Site
  - Kolkata, India, 700014
    - Recruiting
    - Research Site
  - Manipal, India, 576104
    - Suspended
    - Research Site
  - Meerut, India, 250005
    - Recruiting
    - Research Site
  - Mysuru, India, 570015
    - Withdrawn
    - Research Site
  - Nagpur, India, 441108
    - Withdrawn
    - Research Site
  - New Delhi, India, 110029
    - Recruiting
    - Research Site
  - New Delhi, India, 110017
    - Recruiting
    - Research Site
  - New Delhi, India, 110002
    - Recruiting
    - Research Site
  - Pune, India, 411001
    - Withdrawn
    - Research Site
  - Rudrapur, India, 263153
    - Recruiting
    - Research Site
  - Vijayawada, India, 520 008
    - Suspended
    - Research Site
Israel
- - Afula, Israel, 1834111
    - Recruiting
    - Research Site
  - Ashkelon, Israel, 78278
    - Recruiting
    - Research Site
  - Beersheba, Israel, 8410101
    - Recruiting
    - Research Site
  - Be’er Ya‘aqov, Israel, 70300
    - Recruiting
    - Research Site
  - Haifa, Israel, 3109601
    - Recruiting
    - Research Site
  - Holon, Israel, 5840608
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 00000
    - Recruiting
    - Research Site
  - Kfar Saba, Israel, 4428164
    - Recruiting
    - Research Site
  - Nahariya, Israel, 22100
    - Recruiting
    - Research Site
  - Petah Tikva, Israel, 49372
    - Recruiting
    - Research Site
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Research Site
  - Tiberias, Israel, 15208
    - Recruiting
    - Research Site
Italy
- - Acquaviva delle Fonti, Italy, 70021
    - Withdrawn
    - Research Site
  - Bari, Italy, 70124
    - Recruiting
    - Research Site
  - Bergamo, Italy, 24127
    - Recruiting
    - Research Site
  - Brescia, Italy, 25100
    - Recruiting
    - Research Site
  - Catania, Italy, 95100
    - Recruiting
    - Research Site
  - Catanzaro, Italy, 88100
    - Recruiting
    - Research Site
  - Cona, Italy, 44124
    - Recruiting
    - Research Site
  - Cortona, Italy, 52044
    - Recruiting
    - Research Site
  - Florence, Italy, 50134
    - Withdrawn
    - Research Site
  - Milan, Italy, 20138
    - Recruiting
    - Research Site
  - Novara, Italy, 28100
    - Withdrawn
    - Research Site
  - Pavia, Italy, 27100
    - Recruiting
    - Research Site
  - San Giovanni Rotondo, Italy, 71013
    - Withdrawn
    - Research Site
Japan
- - Beppu-shi, Japan, 874-0011
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8431
    - Recruiting
    - Research Site
  - Fujisawa-shi, Japan, 251-8550
    - Recruiting
    - Research Site
  - Fukui-shi, Japan, 910-8526
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 810-8563
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 815-8555
    - Recruiting
    - Research Site
  - Fukutsu-shi, Japan, 811-3298
    - Recruiting
    - Research Site
  - Hakusan-shi, Japan, 924-8588
    - Recruiting
    - Research Site
  - Higashiibaraki-gun, Japan, 311-3193
    - Recruiting
    - Research Site
  - Himeji, Japan, 670-8560
    - Recruiting
    - Research Site
  - Iwakuni-shi, Japan, 740-8510
    - Recruiting
    - Research Site
  - Kanazawa, Japan, 920-8530
    - Recruiting
    - Research Site
  - Kanazawa, Japan, 920-8650
    - Withdrawn
    - Research Site
  - Kanonji-shi, Japan, 769-1695
    - Recruiting
    - Research Site
  - Kasuga-shi, Japan, 816-0864
    - Suspended
    - Research Site
  - Kasugai-shi, Japan, 486-8510
    - Recruiting
    - Research Site
  - Kawaguchi, Japan, 333-0842
    - Recruiting
    - Research Site
  - Kawanishi-shi, Japan, 666-0125
    - Recruiting
    - Research Site
  - Kishiwada-shi, Japan, 596-8522
    - Recruiting
    - Research Site
  - Kitakyusyu-shi, Japan, 806-8501
    - Suspended
    - Research Site
  - Kobe, Japan, 654-0155
    - Recruiting
    - Research Site
  - Kochi, Japan, 780-8535
    - Recruiting
    - Research Site
  - Kure-shi, Japan, 737-8505
    - Recruiting
    - Research Site
  - Maebashi, Japan, 371-8511
    - Recruiting
    - Research Site
  - Matsumoto-shi, Japan, 390-8621
    - Recruiting
    - Research Site
  - Meguro-ku, Japan, 152-8902
    - Recruiting
    - Research Site
  - Mito, Japan, 311-4198
    - Recruiting
    - Research Site
  - Moriyama-shi, Japan, 524-8524
    - Recruiting
    - Research Site
  - Nagoya, Japan, 460-0001
    - Suspended
    - Research Site
  - Osaka, Japan, 540-0006
    - Recruiting
    - Research Site
  - Osaka, Japan, 543-0035
    - Recruiting
    - Research Site
  - Sagamihara-shi, Japan, 252-5188
    - Recruiting
    - Research Site
  - Saitama Shi, Japan, 336 8522
    - Recruiting
    - Research Site
  - Saitama-shi, Japan, 339-0033
    - Withdrawn
    - Research Site
  - Sakaishi, Japan, 599-8247
    - Recruiting
    - Research Site
  - Sakata, Japan, 998-8501
    - Suspended
    - Research Site
  - Sanyoonoda-shi, Japan, 756-0095
    - Recruiting
    - Research Site
  - Toshima-ku, Japan, 171-0014
    - Recruiting
    - Research Site
  - Toyota, Japan, 470-0396
    - Recruiting
    - Research Site
  - Tsuchiura-shi, Japan, 300-0028
    - Terminated
    - Research Site
  - Ueda-shi, Japan, 386-8610
    - Recruiting
    - Research Site
  - Uji-shi, Japan, 611-0041
    - Recruiting
    - Research Site
  - Uwajima-shi, Japan, 798-8510
    - Recruiting
    - Research Site
  - Yanagawa-shi, Japan, 832-0077
    - Recruiting
    - Research Site
  - Yokohama, Japan, 221-0855
    - Recruiting
    - Research Site
  - Yokohama, Japan, 227-8501
    - Withdrawn
    - Research Site
  - Yokohama, Japan, 245-8575
    - Withdrawn
    - Research Site
  - Ōita, Japan, 870-8511
    - Recruiting
    - Research Site
Malaysia
- - Kajang, Malaysia, 43000
    - Recruiting
    - Research Site
  - Kota Kinabalu, Malaysia, 88300
    - Recruiting
    - Research Site
  - Kota Samarahan, Malaysia, 94300
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 50400
    - Recruiting
    - Research Site
  - Kuala Terengganu, Malaysia, 20400
    - Recruiting
    - Research Site
  - Kuantan, Malaysia, 25200
    - Recruiting
    - Research Site
  - Sungai Buloh, Malaysia, 47000
    - Recruiting
    - Research Site
Mexico
- - Aguascalientes, Mexico, 20230
    - Recruiting
    - Research Site
  - Aguascalientes, Mexico, 20230
    - Not yet recruiting
    - Research Site
  - Chihuahua City, Mexico, 31203
    - Recruiting
    - Research Site
  - Cuauhtémoc, Mexico, 6720
    - Not yet recruiting
    - Research Site
  - Cuauhtémoc, Mexico, 06700
    - Recruiting
    - Research Site
  - Culiacán, Mexico, 80230
    - Recruiting
    - Research Site
  - Culiacán, Mexico, 80200
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44670
    - Recruiting
    - Research Site
  - Mazatlán, Mexico, 82110
    - Not yet recruiting
    - Research Site
  - Metepec, Mexico, 52170
    - Recruiting
    - Research Site
  - Mexico City, Mexico, 07300
    - Not yet recruiting
    - Research Site
  - Mexico City, Mexico, 03310
    - Withdrawn
    - Research Site
  - Monterrey, Mexico, 64460
    - Not yet recruiting
    - Research Site
  - Monterrey, Mexico, 64060
    - Not yet recruiting
    - Research Site
  - Morelia, Mexico, 58260
    - Withdrawn
    - Research Site
  - México, Mexico, 07020
    - Recruiting
    - Research Site
  - México, Mexico, 14080
    - Not yet recruiting
    - Research Site
  - México, Mexico, 11650
    - Withdrawn
    - Research Site
  - Querétaro, Mexico, 76000
    - Recruiting
    - Research Site
  - San Luis Potosí City, Mexico, 78250
    - Withdrawn
    - Research Site
  - Tijuana, Mexico, 22150
    - Recruiting
    - Research Site
  - Torreón, Mexico, 27000
    - Recruiting
    - Research Site
  - Veracruz, Mexico, 91910
    - Not yet recruiting
    - Research Site
  - Xalapa, Mexico, 91193
    - Recruiting
    - Research Site
Netherlands
- - Amsterdam, Netherlands, 1091 AC
    - Recruiting
    - Research Site
  - Arnhem, Netherlands, 6815 AD
    - Recruiting
    - Research Site
  - Emmen, Netherlands, 7824 AA
    - Recruiting
    - Research Site
  - Goes, Netherlands, 4462 RA
    - Recruiting
    - Research Site
  - Hardenberg, Netherlands, 7772 SE
    - Recruiting
    - Research Site
  - Leeuwarden, Netherlands, 8934 AD
    - Recruiting
    - Research Site
Peru
- - Bellavista, Peru, CALLAO 2
    - Recruiting
    - Research Site
  - Cusco, Peru, CUSCO 01
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15088
    - Recruiting
    - Research Site
  - Lima, Peru, 15046
    - Recruiting
    - Research Site
  - Lima, Peru, 15072
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15102
    - Not yet recruiting
    - Research Site
  - Lima, Peru, LIMA 27
    - Recruiting
    - Research Site
  - Lima, Peru, 15046
    - Withdrawn
    - Research Site
  - Lima, Peru, L18
    - Withdrawn
    - Research Site
  - Lima, Peru, 15131
    - Withdrawn
    - Research Site
  - Lima, Peru, LIMA 41
    - Recruiting
    - Research Site
  - Lima, Peru, 15024
    - Recruiting
    - Research Site
  - Lima, Peru, LIMA 11
    - Recruiting
    - Research Site
  - Piura, Peru, 20001
    - Recruiting
    - Research Site
Philippines
- - Angeles City, Philippines, 2009
    - Recruiting
    - Research Site
  - Cebu City, Philippines, 6000
    - Recruiting
    - Research Site
  - Cebu City, Philippines, 6000
    - Withdrawn
    - Research Site
  - City of Taguig, Philippines, 1634
    - Recruiting
    - Research Site
  - Davao City, Philippines, 8000
    - Recruiting
    - Research Site
  - Davao City, Philippines, PH-8000
    - Recruiting
    - Research Site
  - Davao City, Philippines, PH-8000
    - Not yet recruiting
    - Research Site
  - Iloilo City, Philippines, 5000
    - Recruiting
    - Research Site
  - Las Piñas, Philippines, PH-1704
    - Recruiting
    - Research Site
  - Mabalacat, Philippines, 2023
    - Recruiting
    - Research Site
  - Makati, Philippines, 1209
    - Recruiting
    - Research Site
  - Manadaluyong City, Philippines, 1552
    - Recruiting
    - Research Site
  - Manila, Philippines, 1008
    - Withdrawn
    - Research Site
  - Marikina City, Philippines, 1800
    - Recruiting
    - Research Site
  - Pasig, Philippines, 1605
    - Recruiting
    - Research Site
  - Quezon City, Philippines, 1101
    - Recruiting
    - Research Site
  - Quezon City, Philippines, 1112
    - Recruiting
    - Research Site
  - Quezon City, Philippines
    - Recruiting
    - Research Site
  - Roxas City, Philippines, 5800
    - Recruiting
    - Research Site
  - West San Juan City, Philippines, 1502
    - Recruiting
    - Research Site
Poland
- - Biała Podlaska, Poland, 21-500
    - Suspended
    - Research Site
  - Bielsko-Biala, Poland, 43-316
    - Withdrawn
    - Research Site
  - Bydgoszcz, Poland, 85-605
    - Withdrawn
    - Research Site
  - Bydgoszcz, Poland, 85-794
    - Terminated
    - Research Site
  - Chrzanów, Poland, 32-500
    - Recruiting
    - Research Site
  - Gdansk, Poland, 80-214
    - Recruiting
    - Research Site
  - Gdansk, Poland, 80-462
    - Recruiting
    - Research Site
  - Gdynia, Poland, 81-157
    - Withdrawn
    - Research Site
  - Katowice, Poland, 40-600
    - Recruiting
    - Research Site
  - Kazimierza Wielka, Poland, 28-500
    - Recruiting
    - Research Site
  - Krakow, Poland, 31-121
    - Recruiting
    - Research Site
  - Krakow, Poland, 30-082
    - Recruiting
    - Research Site
  - Krakow, Poland, 30-688
    - Recruiting
    - Research Site
  - Krakow, Poland, 31-322
    - Recruiting
    - Research Site
  - Krakow, Poland, 31-513
    - Withdrawn
    - Research Site
  - Kędzierzyn-Koźle, Poland, 47-200
    - Recruiting
    - Research Site
  - Lodz, Poland, 93-513
    - Recruiting
    - Research Site
  - Lodz, Poland, 90-549
    - Recruiting
    - Research Site
  - Lodz, Poland, 91-053
    - Withdrawn
    - Research Site
  - Lodz, Poland, 94-046
    - Suspended
    - Research Site
  - Lublin, Poland, 20-857
    - Recruiting
    - Research Site
  - Lublin, Poland, 20-068
    - Recruiting
    - Research Site
  - Lublin, Poland, 20-044
    - Completed
    - Research Site
  - Olsztyn, Poland, 10-165
    - Recruiting
    - Research Site
  - Ostrów Mazowiecka, Poland, 07-300
    - Recruiting
    - Research Site
  - Piekary Śląskie, Poland, 41-940
    - Recruiting
    - Research Site
  - Poznan, Poland, 60-266
    - Recruiting
    - Research Site
  - Poznan, Poland, 61- 848
    - Recruiting
    - Research Site
  - Rzeszów, Poland, 35-205
    - Recruiting
    - Research Site
  - Rzeszów, Poland, 35-055
    - Withdrawn
    - Research Site
  - Szczecin, Poland, 71-526
    - Recruiting
    - Research Site
  - Tarnów, Poland, 33-100
    - Recruiting
    - Research Site
  - Torun, Poland, 87-100
    - Recruiting
    - Research Site
  - Tychy, Poland, 43-100
    - Recruiting
    - Research Site
  - Warsaw, Poland, 00-124
    - Recruiting
    - Research Site
  - Warsaw, Poland, 00-416
    - Withdrawn
    - Research Site
  - Warsaw, Poland, 04-501
    - Withdrawn
    - Research Site
  - Wroclaw, Poland, 53-602
    - Withdrawn
    - Research Site
  - Wroclaw, Poland, 53-605
    - Recruiting
    - Research Site
  - Zabrze, Poland, 41-800
    - Recruiting
    - Research Site
Romania
- - Afumaţi, Romania, 077010
    - Recruiting
    - Research Site
  - Arad, Romania, 310037
    - Recruiting
    - Research Site
  - Baia Mare, Romania, 430222
    - Recruiting
    - Research Site
  - Brasov, Romania, 500102
    - Recruiting
    - Research Site
  - Brasov, Romania, 500388
    - Recruiting
    - Research Site
  - Bucharest, Romania, 014461
    - Recruiting
    - Research Site
  - Bucharest, Romania, 022328
    - Recruiting
    - Research Site
  - Bucharest, Romania, 040883
    - Withdrawn
    - Research Site
  - Bucharest, Romania, 010825
    - Not yet recruiting
    - Research Site
  - Bucharest, Romania, 014461
    - Terminated
    - Research Site
  - Cluj-Napoca, Romania, 400437
    - Terminated
    - Research Site
  - Iași, Romania, 700503
    - Recruiting
    - Research Site
  - Iași, Romania, 700010
    - Suspended
    - Research Site
  - Satu Mare, Romania, 440192
    - Recruiting
    - Research Site
  - Timișoara, Romania, 300254
    - Recruiting
    - Research Site
  - Timișoara, Romania, 300310
    - Terminated
    - Research Site
  - Târgu Mureş, Romania, 540099
    - Recruiting
    - Research Site
  - Târgu Mureş, Romania, 540136
    - Recruiting
    - Research Site
Saudi Arabia
- - Dammam, Saudi Arabia, 31463
    - Not yet recruiting
    - Research Site
  - Jeddah, Saudi Arabia, 22384
    - Recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 11426
    - Recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 11525
    - Recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 12713
    - Recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 11462
    - Recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 11481
    - Not yet recruiting
    - Research Site
Slovakia
- - Banská Bystrica, Slovakia, 974 01
    - Recruiting
    - Research Site
  - Bratislava, Slovakia, 831 01
    - Recruiting
    - Research Site
  - Bratislava, Slovakia, 841 08
    - Recruiting
    - Research Site
  - Brezno, Slovakia, 977 01
    - Recruiting
    - Research Site
  - Košice, Slovakia, 04022
    - Recruiting
    - Research Site
  - Košice, Slovakia, 040 01
    - Recruiting
    - Research Site
  - Martin, Slovakia, 036 01
    - Recruiting
    - Research Site
  - Myjava, Slovakia, 90701
    - Recruiting
    - Research Site
  - Nitra, Slovakia, 949 01
    - Recruiting
    - Research Site
  - Nové Zámky, Slovakia, 940 01
    - Withdrawn
    - Research Site
  - Považská Bystrica, Slovakia, 017 01
    - Recruiting
    - Research Site
  - Prešov, Slovakia, 080 01
    - Withdrawn
    - Research Site
  - Rimavská Sobota, Slovakia, 979 01
    - Recruiting
    - Research Site
  - Rimavská Sobota, Slovakia, 979 01
    - Suspended
    - Research Site
  - Svidník, Slovakia, 08901
    - Recruiting
    - Research Site
South Africa
- - Bloemfontein, South Africa, 9301
    - Recruiting
    - Research Site
  - Centurion, South Africa, 0157
    - Recruiting
    - Research Site
  - Durban, South Africa, 4052
    - Recruiting
    - Research Site
  - Johannesburg, South Africa, 2193
    - Recruiting
    - Research Site
  - KwaDukuza, South Africa, 4449
    - Recruiting
    - Research Site
  - Panorama, South Africa, 7500
    - Recruiting
    - Research Site
  - Parow, South Africa, 7505
    - Recruiting
    - Research Site
  - Pietermaritzburg, South Africa, 3201
    - Recruiting
    - Research Site
  - Somerset West, South Africa, 7130
    - Recruiting
    - Research Site
  - Soweto, South Africa, 2013
    - Recruiting
    - Research Site
  - Worcester, South Africa, 6850
    - Withdrawn
    - Research Site
South Korea
- - Anyang-si, South Korea, 14068
    - Recruiting
    - Research Site
  - Bucheon-si, South Korea, 14754
    - Recruiting
    - Research Site
  - Busan, South Korea, 47392
    - Recruiting
    - Research Site
  - Busan, South Korea, 49201
    - Recruiting
    - Research Site
  - Busan, South Korea, 49241
    - Recruiting
    - Research Site
  - Busan, South Korea, 49267
    - Recruiting
    - Research Site
  - Cheongju-si, South Korea, 28644
    - Recruiting
    - Research Site
  - Daegu, South Korea, 42601
    - Recruiting
    - Research Site
  - Daejeon, South Korea, 35015
    - Recruiting
    - Research Site
  - Gwangju, South Korea, 61469
    - Recruiting
    - Research Site
  - Gwangmyeong, South Korea, 14353
    - Recruiting
    - Research Site
  - Incheon, South Korea, 21565
    - Recruiting
    - Research Site
  - Junggu, South Korea, 22332
    - Recruiting
    - Research Site
  - Seongnam-si, South Korea, 13620
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 05505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Recruiting
    - Research Site
  - Seoul, South Korea, 08308
    - Recruiting
    - Research Site
  - Seoul, South Korea, 02841
    - Recruiting
    - Research Site
  - Seoul, South Korea, 04763
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Withdrawn
    - Research Site
  - Uijeongbu-si, South Korea, 11765
    - Recruiting
    - Research Site
  - Wŏnju, South Korea, 26426
    - Terminated
    - Research Site
  - Yangsan, South Korea, 50612
    - Recruiting
    - Research Site
Spain
- - A Coruña, Spain, 15006
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08035
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08036
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08025
    - Recruiting
    - Research Site
  - Lugo, Spain, 27004
    - Recruiting
    - Research Site
  - Madrid, Spain, 28007
    - Recruiting
    - Research Site
  - Madrid, Spain, 28027
    - Recruiting
    - Research Site
  - Majadahonda, Spain, 28222
    - Recruiting
    - Research Site
  - Seville, Spain, 41013
    - Recruiting
    - Research Site
  - Seville, Spain, 41004
    - Recruiting
    - Research Site
  - Seville, Spain, 41071
    - Recruiting
    - Research Site
  - Valencia, Spain, 46010
    - Recruiting
    - Research Site
Sweden
- - Alingsås, Sweden, 441 83
    - Withdrawn
    - Research Site
  - Gothenburg, Sweden, 413 46
    - Recruiting
    - Research Site
  - Jönköping, Sweden, 55305
    - Recruiting
    - Research Site
  - Karlstad, Sweden, 651 85
    - Recruiting
    - Research Site
  - Mölndal, Sweden, SE431 80
    - Recruiting
    - Research Site
  - Stockholm, Sweden, 112 81
    - Recruiting
    - Research Site
  - Stockholm, Sweden, 118 83
    - Recruiting
    - Research Site
  - Stockholm, Sweden, 18288
    - Recruiting
    - Research Site
  - Stockholm, Sweden, 171 64
    - Recruiting
    - Research Site
  - Uppsala, Sweden, 751 85
    - Recruiting
    - Research Site
  - Västerås, Sweden, 721 89
    - Recruiting
    - Research Site
Taiwan
- - Changhua, Taiwan, 500
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 81362
    - Recruiting
    - Research Site
  - New Taipei City, Taiwan, 220
    - Recruiting
    - Research Site
  - New Taipei City, Taiwan, 25160
    - Recruiting
    - Research Site
  - New Taipei City, Taiwan, 231
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 433004
    - Recruiting
    - Research Site
  - Taipei, Taiwan, TAIWAN
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11217
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10449
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 0116
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11101
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 110
    - Recruiting
    - Research Site
  - Taoyuan District, Taiwan, 333
    - Recruiting
    - Research Site
  - Yilan, Taiwan, 260
    - Recruiting
    - Research Site
  - Yung Kang City, Taiwan, 71044
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Chiang Mai, Thailand, 50200
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Research Site
  - Naimuang, Thailand, 30000
    - Recruiting
    - Research Site
  - Pathum Thani, Thailand, 12120
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01060
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06
    - Recruiting
    - Research Site
  - Antalya, Turkey (Türkiye), 07059
    - Recruiting
    - Research Site
  - Antalya, Turkey (Türkiye), 07100
    - Recruiting
    - Research Site
  - Bursa, Turkey (Türkiye), 16059
    - Completed
    - Research Site
  - Center, Turkey (Türkiye), 78200
    - Recruiting
    - Research Site
  - Dinar, Turkey (Türkiye), 03400
    - Recruiting
    - Research Site
  - Eskişehir, Turkey (Türkiye), 26480
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34668
    - Withdrawn
    - Research Site
  - Izmir, Turkey (Türkiye), 35340
    - Recruiting
    - Research Site
  - Kocaeli, Turkey (Türkiye), 41380
    - Recruiting
    - Research Site
  - Kütahya, Turkey (Türkiye), 43100
    - Recruiting
    - Research Site
  - Muğla, Turkey (Türkiye), 48000
    - Active, not recruiting
    - Research Site
  - Sivas, Turkey (Türkiye), 58140
    - Recruiting
    - Research Site
Ukraine
- - Chernivtsі, Ukraine, 58002
    - Recruiting
    - Research Site
  - Ivano-Frankivsk, Ukraine, 76018
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 04050
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 01601
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 02081
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 03037
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 03680
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 03151
    - Recruiting
    - Research Site
  - Ternopil, Ukraine, 46000
    - Recruiting
    - Research Site
  - Ternopil, Ukraine, 46002
    - Recruiting
    - Research Site
  - Uzhhorod, Ukraine, 88014
    - Recruiting
    - Research Site
  - Vinnytsia, Ukraine, 21001
    - Recruiting
    - Research Site
  - Vinnytsia, Ukraine, 21029
    - Recruiting
    - Research Site
  - Zhytomyr, Ukraine, 100002
    - Recruiting
    - Research Site
United Kingdom
- - Airdrie, United Kingdom, ML6 0JS
    - Recruiting
    - Research Site
  - Barnet, United Kingdom, EN5 3DJ
    - Recruiting
    - Research Site
  - Cambridge, United Kingdom, CB2 0AY
    - Withdrawn
    - Research Site
  - Clydebank, United Kingdom, G81 4DY
    - Recruiting
    - Research Site
  - Exeter, United Kingdom, EX2 5DW
    - Recruiting
    - Research Site
  - Harefield, United Kingdom, UB9 6JH
    - Recruiting
    - Research Site
  - Hastings, United Kingdom, TN37 7RD
    - Recruiting
    - Research Site
  - High Wycombe, United Kingdom, HP11 2TT
    - Withdrawn
    - Research Site
  - Kent, United Kingdom, BR6 8ND
    - Recruiting
    - Research Site
  - Kings Lynn, United Kingdom, PE30 4ET
    - Recruiting
    - Research Site
  - Lincoln, United Kingdom, LN2 5QY
    - Withdrawn
    - Research Site
  - London, United Kingdom, SE5 9RS
    - Withdrawn
    - Research Site
  - London, United Kingdom, EC1M 6BQ
    - Completed
    - Research Site
  - Middlesbrough, United Kingdom, TS4 3BW
    - Recruiting
    - Research Site
  - Portsmouth, United Kingdom, PO6 3LY
    - Recruiting
    - Research Site
  - Sheffield, United Kingdom, S5 7AU
    - Withdrawn
    - Research Site
  - Sunderland, United Kingdom, SR4 7TP
    - Recruiting
    - Research Site
  - Wakefield, United Kingdom, WF1 4DG
    - Recruiting
    - Research Site
United States
- Alabama
  - Alexander City, Alabama, United States, 35010
    - Recruiting
    - Research Site
  - Birmingham, Alabama, United States, 35209
    - Withdrawn
    - Research Site
  - Fairhope, Alabama, United States, 36532
    - Recruiting
    - Research Site
  - Huntsville, Alabama, United States, 35801
    - Recruiting
    - Research Site
- Arizona
  - Phoenix, Arizona, United States, 85016
    - Recruiting
    - Research Site
  - Phoenix, Arizona, United States, 85044
    - Recruiting
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Recruiting
    - Research Site
- California
  - Beverly Hills, California, United States, 90211
    - Recruiting
    - Research Site
  - Covina, California, United States, 91723
    - Recruiting
    - Research Site
  - Encinitas, California, United States, 92024
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90089
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90073
    - Recruiting
    - Research Site
  - Newport Beach, California, United States, 92663
    - Terminated
    - Research Site
  - Orange, California, United States, 92868
    - Withdrawn
    - Research Site
  - Redding, California, United States, 96001
    - Recruiting
    - Research Site
  - San Diego, California, United States, 92123
    - Recruiting
    - Research Site
  - San Francisco, California, United States, 94121
    - Recruiting
    - Research Site
  - San Francisco, California, United States, 94110
    - Recruiting
    - Research Site
  - Santa Ana, California, United States, 92704
    - Withdrawn
    - Research Site
  - Thousand Oaks, California, United States, 91360
    - Terminated
    - Research Site
  - Vista, California, United States, 92081
    - Recruiting
    - Research Site
  - West Hills, California, United States, 91307
    - Recruiting
    - Research Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - Research Site
  - Wheat Ridge, Colorado, United States, 80033
    - Terminated
    - Research Site
- Florida
  - Altamonte Springs, Florida, United States, 32701
    - Terminated
    - Research Site
  - Boca Raton, Florida, United States, 33486
    - Recruiting
    - Research Site
  - Bradenton, Florida, United States, 34209
    - Recruiting
    - Research Site
  - Clearwater, Florida, United States, 33756
    - Withdrawn
    - Research Site
  - Delray Beach, Florida, United States, 33484
    - Recruiting
    - Research Site
  - Fort Lauderdale, Florida, United States, 33308
    - Recruiting
    - Research Site
  - Gainesville, Florida, United States, 32610
    - Recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32209
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33176
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33133
    - Terminated
    - Research Site
  - Miami Lakes, Florida, United States, 33014
    - Recruiting
    - Research Site
  - Palm Beach Gardens, Florida, United States, 33410
    - Recruiting
    - Research Site
  - Pensacola, Florida, United States, 32503
    - Recruiting
    - Research Site
  - Port Charlotte, Florida, United States, 33952
    - Withdrawn
    - Research Site
  - Safety Harbor, Florida, United States, 34695
    - Recruiting
    - Research Site
  - Saint Augustine, Florida, United States, 32086
    - Recruiting
    - Research Site
  - St. Petersburg, Florida, United States, 33701
    - Recruiting
    - Research Site
  - Tampa, Florida, United States, 33617
    - Recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Recruiting
    - Research Site
  - Atlanta, Georgia, United States, 30309
    - Recruiting
    - Research Site
  - Peachtree City, Georgia, United States, 30269
    - Recruiting
    - Research Site
  - Thomasville, Georgia, United States, 31792
    - Recruiting
    - Research Site
  - Tucker, Georgia, United States, 30084
    - Recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - Research Site
  - Chicago, Illinois, United States, 60612
    - Withdrawn
    - Research Site
  - Glenview, Illinois, United States, 60026
    - Recruiting
    - Research Site
  - Hazel Crest, Illinois, United States, 60429
    - Recruiting
    - Research Site
  - North Chicago, Illinois, United States, 60064
    - Terminated
    - Research Site
  - Peoria, Illinois, United States, 61614
    - Recruiting
    - Research Site
  - Winfield, Illinois, United States, 60190
    - Recruiting
    - Research Site
- Indiana
  - Elkhart, Indiana, United States, 46514
    - Recruiting
    - Research Site
  - Evansville, Indiana, United States, 47710
    - Recruiting
    - Research Site
  - Hammond, Indiana, United States, 46324
    - Recruiting
    - Research Site
  - Indianapolis, Indiana, United States, 46237
    - Withdrawn
    - Research Site
  - Muncie, Indiana, United States, 47303
    - Recruiting
    - Research Site
  - Munster, Indiana, United States, 46321
    - Recruiting
    - Research Site
  - Richmond, Indiana, United States, 47374
    - Withdrawn
    - Research Site
- Iowa
  - Waterloo, Iowa, United States, 50701
    - Recruiting
    - Research Site
- Kansas
  - Wichita, Kansas, United States, 67226
    - Recruiting
    - Research Site
  - Wichita, Kansas, United States, 67218
    - Withdrawn
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Terminated
    - Research Site
- Louisiana
  - Alexandria, Louisiana, United States, 71301
    - Withdrawn
    - Research Site
  - New Orleans, Louisiana, United States, 70121
    - Withdrawn
    - Research Site
  - Shreveport, Louisiana, United States, 71105
    - Withdrawn
    - Research Site
  - West Monroe, Louisiana, United States, 71291
    - Recruiting
    - Research Site
- Maine
  - Augusta, Maine, United States, 04330
    - Withdrawn
    - Research Site
- Maryland
  - Rockville, Maryland, United States, 20850
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Research Site
  - Fall River, Massachusetts, United States, 02721
    - Withdrawn
    - Research Site
  - Worcester, Massachusetts, United States, 01655
    - Recruiting
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Withdrawn
    - Research Site
  - Bloomfield Hills, Michigan, United States, 48304
    - Recruiting
    - Research Site
  - Dearborn, Michigan, United States, 48126
    - Terminated
    - Research Site
  - Farmington Hills, Michigan, United States, 48334
    - Recruiting
    - Research Site
  - Flint, Michigan, United States, 48504
    - Recruiting
    - Research Site
  - Troy, Michigan, United States, 48098
    - Withdrawn
    - Research Site
  - Ypsilanti, Michigan, United States, 48197
    - Recruiting
    - Research Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - Withdrawn
    - Research Site
  - Saint Paul, Minnesota, United States, 55109
    - Recruiting
    - Research Site
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Recruiting
    - Research Site
- Missouri
  - Columbia, Missouri, United States, 65201
    - Recruiting
    - Research Site
  - Kansas City, Missouri, United States, 64111
    - Recruiting
    - Research Site
  - Kansas City, Missouri, United States, 64128
    - Recruiting
    - Research Site
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Recruiting
    - Research Site
  - Lincoln, Nebraska, United States, 68506
    - Recruiting
    - Research Site
- Nevada
  - Henderson, Nevada, United States, 89074
    - Recruiting
    - Research Site
  - North Las Vegas, Nevada, United States, 89086
    - Withdrawn
    - Research Site
- New Jersey
  - Bridgewater, New Jersey, United States, 08807
    - Withdrawn
    - Research Site
  - Jersey City, New Jersey, United States, 07302
    - Recruiting
    - Research Site
  - Somerset, New Jersey, United States, 08873
    - Recruiting
    - Research Site
- New York
  - Albany, New York, United States, 12208
    - Withdrawn
    - Research Site
  - Brooklyn, New York, United States, 11220
    - Recruiting
    - Research Site
  - Brooklyn, New York, United States, 11219
    - Not yet recruiting
    - Research Site
  - Clifton Park, New York, United States, 12065
    - Not yet recruiting
    - Research Site
  - Manhasset, New York, United States, 11030
    - Withdrawn
    - Research Site
  - New Windsor, New York, United States, 12553
    - Withdrawn
    - Research Site
  - New York, New York, United States, 10029
    - Recruiting
    - Research Site
  - Staten Island, New York, United States, 10310
    - Recruiting
    - Research Site
  - Stony Brook, New York, United States, 11794
    - Withdrawn
    - Research Site
  - The Bronx, New York, United States, 10451
    - Recruiting
    - Research Site
  - The Bronx, New York, United States, 10455
    - Recruiting
    - Research Site
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Recruiting
    - Research Site
  - Chapel Hill, North Carolina, United States, 27517
    - Recruiting
    - Research Site
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Research Site
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Research Site
  - Greensboro, North Carolina, United States, 27405
    - Withdrawn
    - Research Site
  - Pinehurst, North Carolina, United States, 28374
    - Recruiting
    - Research Site
  - Statesville, North Carolina, United States, 28625
    - Recruiting
    - Research Site
  - Wilmington, North Carolina, United States, 28401
    - Recruiting
    - Research Site
- Ohio
  - Cincinnati, Ohio, United States, 45267
    - Recruiting
    - Research Site
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - Research Site
  - Dayton, Ohio, United States, 45414
    - Recruiting
    - Research Site
  - Maumee, Ohio, United States, 43537
    - Withdrawn
    - Research Site
  - Springfield, Ohio, United States, 45504
    - Recruiting
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73102
    - Withdrawn
    - Research Site
- Oregon
  - Portland, Oregon, United States, 97225
    - Recruiting
    - Research Site
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Recruiting
    - Research Site
  - Camp Hill, Pennsylvania, United States, 17011
    - Recruiting
    - Research Site
  - Hershey, Pennsylvania, United States, 17033
    - Recruiting
    - Research Site
  - Horsham, Pennsylvania, United States, 19044
    - Terminated
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - Research Site
- Rhode Island
  - Providence, Rhode Island, United States, 02908
    - Recruiting
    - Research Site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Terminated
    - Research Site
  - Charleston, South Carolina, United States, 29401
    - Recruiting
    - Research Site
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Research Site
  - Ladson, South Carolina, United States, 29456
    - Withdrawn
    - Research Site
  - Lancaster, South Carolina, United States, 29720
    - Recruiting
    - Research Site
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Recruiting
    - Research Site
- Tennessee
  - Jackson, Tennessee, United States, 38305
    - Recruiting
    - Research Site
  - Knoxville, Tennessee, United States, 37916
    - Recruiting
    - Research Site
  - Memphis, Tennessee, United States, 38120
    - Recruiting
    - Research Site
  - Memphis, Tennessee, United States, 38128
    - Terminated
    - Research Site
  - Nashville, Tennessee, United States, 37212
    - Recruiting
    - Research Site
  - Tullahoma, Tennessee, United States, 37388
    - Recruiting
    - Research Site
- Texas
  - Allen, Texas, United States, 75013
    - Recruiting
    - Research Site
  - Amarillo, Texas, United States, 79106
    - Recruiting
    - Research Site
  - Amarillo, Texas, United States, 79121
    - Recruiting
    - Research Site
  - Cypress, Texas, United States, 77429
    - Recruiting
    - Research Site
  - Dallas, Texas, United States, 75216
    - Recruiting
    - Research Site
  - Dallas, Texas, United States, 75390
    - Recruiting
    - Research Site
  - Dallas, Texas, United States, 75204
    - Recruiting
    - Research Site
  - El Paso, Texas, United States, 79905
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77025
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77002
    - Terminated
    - Research Site
  - Katy, Texas, United States, 77493
    - Terminated
    - Research Site
  - Mansfield, Texas, United States, 76063
    - Terminated
    - Research Site
  - McKinney, Texas, United States, 75069
    - Recruiting
    - Research Site
  - McKinney, Texas, United States, 75071
    - Recruiting
    - Research Site
  - Odessa, Texas, United States, 79761
    - Recruiting
    - Research Site
  - Pearland, Texas, United States, 77584
    - Suspended
    - Research Site
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Research Site
  - Sherman, Texas, United States, 75092
    - Terminated
    - Research Site
  - Temple, Texas, United States, 76508
    - Recruiting
    - Research Site
  - Tyler, Texas, United States, 75702
    - Recruiting
    - Research Site
  - Tyler, Texas, United States, 75701
    - Recruiting
    - Research Site
- Utah
  - Salt Lake City, Utah, United States, 84107
    - Withdrawn
    - Research Site
  - Salt Lake City, Utah, United States, 84148
    - Recruiting
    - Research Site
- Virginia
  - Falls Church, Virginia, United States, 22042
    - Recruiting
    - Research Site
  - Newport News, Virginia, United States, 23606
    - Recruiting
    - Research Site
- Washington
  - Puyallup, Washington, United States, 98372
    - Withdrawn
    - Research Site
  - Seattle, Washington, United States, 98101
    - Withdrawn
    - Research Site
  - Tacoma, Washington, United States, 98405
    - Withdrawn
    - Research Site
Vietnam
- - Can Tho, Vietnam, 900000
    - Recruiting
    - Research Site
  - Da Nang, Vietnam, 550000
    - Recruiting
    - Research Site
  - Haiphong, Vietnam, 180000
    - Recruiting
    - Research Site
  - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 70000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 70000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Hochiminh, Vietnam, 70000
    - Recruiting
    - Research Site
  - Hochiminh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Huế, Vietnam, 530000
    - Recruiting
    - Research Site
  - Hà Nội, Vietnam, 100000
    - Recruiting
    - Research Site
  - Hồ Chí Minh, Vietnam, 700000
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Age ≥ 18 years
Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
Having had a recent HF event within 6 months (hospitalization or urgent visit)
Have a LVEF value from an assessment within the last 12 months
Managed with SoC therapy for HF and renal impairment according to local guidelines
NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter)
Not taking an MRA
An eGFR ≥ 20 to < 60 mL/min/1.73 m2
Serum/plasma potassium ≤ 5.0 mmol/L

Exclusion Criteria:

Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period
Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations
History of hypertrophic obstructive cardiomyopathy
Complex congenital heart disease or severe uncorrected primary valvular disease
Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
Systolic BP < 90 mmHg, or symptomatic hypotension within the past 24 hours
Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment
Type 1 diabetes mellitus
Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy
Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
Treatment with strong or moderate CYP3A4 inhibitor or inducer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: balcinrenone/dapagliflozin 15 mg/10 mg Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin	Drug: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg 1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Experimental: balcinrenone/dapagliflozin 40 mg/10 mg Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin	Drug: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg 1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Active Comparator: dapagliflozin 10 mg Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin	Drug: dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin 1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation Time Frame: Approximately 38 months	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation	Approximately 38 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation Time Frame: Approximately 38 months	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total occurrences of CV death, and HF events with and without hospitalisation	Approximately 38 months
Total occurrences (first and recurrent) of HF hospitalisations Time Frame: Approximately 38 months	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total HF hospitalisations	Approximately 38 months
Time to CV death Time Frame: Approximately 38 months	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death	Approximately 38 months
The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation Time Frame: Approximately 24 weeks	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause, HF events, and improving patient reported symptoms of HF	Approximately 24 weeks
Time to death from any cause Time Frame: Approximately 38 months	To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause	Approximately 38 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Bhattacharya CS, Ericsson H, Johansson S, Parkinson J, Boca SM, Yang Y, Heijer M, Housler G, Leonsson-Zachrisson M, Hartleib-Geschwindner J, Pizzato PE. The effect of severe renal impairment on the pharmacokinetics, safety and tolerability of balcinrenone. Br J Clin Pharmacol. 2025 Jul;91(7):1937-1946. doi: 10.1002/bcp.70017. Epub 2025 Feb 17.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2024

Primary Completion (Estimated)

June 11, 2027

Study Completion (Estimated)

June 11, 2027

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D6402C00012
2023-508162-15-00 (Registry Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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