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

April 29, 2024 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
    - Not yet recruiting
    - Research Site
  - Buenos Aires, Argentina, C1180AAX
    - Not yet recruiting
    - Research Site
  - Buenos Aires, Argentina, C1430EGF
    - Not yet recruiting
    - Research Site
  - Buenos Aires, Argentina, 1425DES
    - Not yet recruiting
    - Research Site
  - Caba, Argentina, C1425AGC
    - Not yet recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1419AHL
    - Not yet recruiting
    - Research Site
  - Cordoba, Argentina, X5006CBI
    - Not yet recruiting
    - Research Site
  - Corrientes, Argentina, W3400CDS
    - Not yet recruiting
    - Research Site
  - Córdoba, Argentina, X5003DCE
    - Not yet recruiting
    - Research Site
  - Esperanza, Argentina, S3080BQU
    - Not yet recruiting
    - Research Site
  - Florencio Varela, Argentina, 1888
    - Not yet recruiting
    - Research Site
  - Ganadero Baigorria, Argentina, 2152
    - Not yet recruiting
    - Research Site
  - Mar del Plata, Argentina, B7600GNY
    - Not yet recruiting
    - Research Site
  - Rosario, Argentina, 2123
    - Not yet recruiting
    - Research Site
  - San Miguel de Tucuman, Argentina, 4000
    - Not yet recruiting
    - Research Site
  - San Miguel de Tucuman, Argentina, 4000
    - Withdrawn
    - Research Site
  - San Miguel de Tucuman, Argentina, T4000ICL
    - Not yet recruiting
    - Research Site
  - Santa Fe, Argentina, S3000FWO
    - Not yet recruiting
    - Research Site
Australia
- - Chermside, Australia, 4032
    - Recruiting
    - Research Site
  - Frankston, Australia, 3199
    - Not yet recruiting
    - Research Site
  - Geelong, Australia, 3220
    - Recruiting
    - Research Site
  - Murdoch, Australia, WA6150
    - Not yet recruiting
    - Research Site
Austria
- - Braunau am Inn, Austria, 5280
    - Not yet recruiting
    - Research Site
  - Graz, Austria, 8036
    - Not yet recruiting
    - Research Site
  - Linz, Austria, 4020
    - Not yet recruiting
    - Research Site
  - Saint Stefan/Stainz, Austria, 8511
    - Not yet recruiting
    - Research Site
  - Salzburg, Austria, 5020
    - Not yet recruiting
    - Research Site
  - St. Pölten, Austria, 3100
    - Not yet recruiting
    - Research Site
  - Wien, Austria, 1090
    - Not yet recruiting
    - Research Site
  - Wien, Austria, 1100
    - Not yet recruiting
    - Research Site
  - Wien, Austria, 1160
    - Not yet recruiting
    - Research Site
Brazil
- - Aracaju, Brazil, 49015-380
    - Not yet recruiting
    - Research Site
  - Blumenau, Brazil, 89020-430
    - Not yet recruiting
    - Research Site
  - Brasilia, Brazil, 70200-730
    - Not yet recruiting
    - Research Site
  - Campina Grande do Sul, Brazil, 83.430-000
    - Not yet recruiting
    - Research Site
  - Campinas, Brazil, 13060-080
    - Not yet recruiting
    - Research Site
  - Curitiba, Brazil, 80730-150
    - Not yet recruiting
    - Research Site
  - Goiania, Brazil, 74605-020
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-903
    - Not yet recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 20551-030
    - Not yet recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 20241-180
    - Not yet recruiting
    - Research Site
  - Sao Jose dos Campos, Brazil, 12230-001
    - Not yet recruiting
    - Research Site
  - Sao Paulo, Brazil, 05403-000
    - Not yet recruiting
    - Research Site
  - São Paulo, Brazil, 04012-180
    - Not yet recruiting
    - Research Site
  - Teresina, Brazil, 64049-550
    - Not yet recruiting
    - Research Site
  - Uberlândia, Brazil, 38400-500
    - Not yet recruiting
    - Research Site
Canada
- British Columbia
  - New Westminster, British Columbia, Canada, V3L 3W4
    - Not yet recruiting
    - Research Site
  - North Vancouver, British Columbia, Canada, V7M 2H4
    - Not yet recruiting
    - Research Site
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - Not yet recruiting
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - Not yet recruiting
    - Research Site
- Nova Scotia
  - Sydney, Nova Scotia, Canada, B1P 1P3
    - Not yet recruiting
    - Research Site
- Ontario
  - Cambridge, Ontario, Canada, N1R 6V6
    - Not yet recruiting
    - Research Site
  - London, Ontario, Canada, N6A 5A5
    - Not yet recruiting
    - Research Site
  - Newmarket, Ontario, Canada, L3Y 2P6
    - Not yet recruiting
    - Research Site
  - North York, Ontario, Canada, M6B 3H7
    - Not yet recruiting
    - Research Site
  - Oshawa, Ontario, Canada, L1J 2K1
    - Recruiting
    - Research Site
  - Ottawa, Ontario, Canada, K1Y 4W7
    - Not yet recruiting
    - Research Site
  - Peterborough, Ontario, Canada, K9J 0B2
    - Not yet recruiting
    - Research Site
  - Toronto, Ontario, Canada, M6G 1M2
    - Not yet recruiting
    - Research Site
  - Waterloo, Ontario, Canada, N2T 0C1
    - Not yet recruiting
    - Research Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 7K9
    - Not yet recruiting
    - Research Site
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Not yet recruiting
    - Research Site
  - Montreal, Quebec, Canada, H4J 1C5
    - Not yet recruiting
    - Research Site
  - Montreal, Quebec, Canada, H3G 1A4
    - Withdrawn
    - Research Site
  - St Jean sur Richelieu, Quebec, Canada, J3A 1J2
    - Not yet recruiting
    - Research Site
  - Trois-Rivières, Quebec, Canada, G9A 4P3
    - Not yet recruiting
    - Research Site
Chile
- - Antofagasta, Chile
    - Not yet recruiting
    - Research Site
  - Punta Arenas, Chile, 6200000
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 7500922
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 8330044
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 7500587
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 8910259
    - Not yet recruiting
    - Research Site
  - Temuco, Chile, 4781156
    - Not yet recruiting
    - Research Site
  - Temuco, Chile, 4810345
    - Not yet recruiting
    - Research Site
  - Valdivia, Chile, 5110683
    - Not yet recruiting
    - Research Site
  - Victoria, Chile, 4720097
    - Not yet recruiting
    - Research Site
China
- - Beijing, China, 100730
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100029
    - Not yet recruiting
    - Research Site
  - Changsha, China, 430033
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410015
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610041
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610072
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510515
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310014
    - Not yet recruiting
    - Research Site
  - Lanzhou, China, 730030
    - Not yet recruiting
    - Research Site
  - Nanjing, China, 210029
    - Not yet recruiting
    - Research Site
  - Pingxiang, China, 337055
    - Not yet recruiting
    - Research Site
  - Wuhan, China, 430022
    - Not yet recruiting
    - Research Site
  - Wuhan, China, 430030
    - Not yet recruiting
    - Research Site
  - Xian, China, 710061
    - Not yet recruiting
    - Research Site
Colombia
- - Armenia, Colombia, 630004
    - Not yet recruiting
    - Research Site
  - Barranquilla, Colombia, 80007
    - Not yet recruiting
    - Research Site
  - Bogotá, Colombia
    - Not yet recruiting
    - Research Site
  - Bogotá, Colombia, 110221
    - Not yet recruiting
    - Research Site
  - Bucaramanga, Colombia
    - Not yet recruiting
    - Research Site
  - Cali, Colombia, 760032
    - Not yet recruiting
    - Research Site
  - Cali, Colombia, 760036
    - Not yet recruiting
    - Research Site
  - Medellin, Colombia, 050034
    - Not yet recruiting
    - Research Site
  - Medellin, Colombia, 050030
    - Not yet recruiting
    - Research Site
  - Rionegro, Colombia, 054047
    - Not yet recruiting
    - Research Site
Czechia
- - Brno, Czechia, 60200
    - Not yet recruiting
    - Research Site
  - Brno, Czechia, 639 00
    - Not yet recruiting
    - Research Site
  - Broumov, Czechia, 55001
    - Not yet recruiting
    - Research Site
  - Ceska Lipa, Czechia, 470 77
    - Not yet recruiting
    - Research Site
  - Jaromer, Czechia, 551 01
    - Not yet recruiting
    - Research Site
  - Louny, Czechia, 440 01
    - Not yet recruiting
    - Research Site
  - Plzen, Czechia, 31001
    - Not yet recruiting
    - Research Site
  - Plzen - Bory, Czechia, 305 99
    - Not yet recruiting
    - Research Site
  - Praha 2, Czechia, 120 00
    - Not yet recruiting
    - Research Site
  - Prerov, Czechia, 75152
    - Not yet recruiting
    - Research Site
  - Slany, Czechia, 274 01
    - Not yet recruiting
    - Research Site
  - Svitavy, Czechia, 568 25
    - Not yet recruiting
    - Research Site
  - Ustí nad Labem, Czechia, 40011
    - Not yet recruiting
    - Research Site
  - Zlin, Czechia, 760 01
    - Not yet recruiting
    - Research Site
Finland
- - Helsinki, Finland, 00290
    - Not yet recruiting
    - Research Site
  - Jyväskylä, Finland, 40620
    - Not yet recruiting
    - Research Site
  - Tampere, Finland, 33520
    - Not yet recruiting
    - Research Site
  - Turku, Finland, 20520
    - Not yet recruiting
    - Research Site
France
- - Beziers, France, 34500
    - Not yet recruiting
    - Research Site
  - Bron, France, 69667
    - Not yet recruiting
    - Research Site
  - Caen Cedex 9, France, 14033
    - Not yet recruiting
    - Research Site
  - Creteil, France, 94010
    - Not yet recruiting
    - Research Site
  - Dijon, France, 21079
    - Not yet recruiting
    - Research Site
  - La Tronche, France, 38043
    - Not yet recruiting
    - Research Site
  - Le Coudray, France, 28630
    - Not yet recruiting
    - Research Site
  - Limoges, France, 87000
    - Not yet recruiting
    - Research Site
  - Montauban, France, 82017
    - Not yet recruiting
    - Research Site
  - Montpellier Cedex, France, 34295
    - Not yet recruiting
    - Research Site
  - Nantes cedex 1, France, 44093
    - Not yet recruiting
    - Research Site
  - Orleans, France, 45100
    - Not yet recruiting
    - Research Site
  - Paris, France, 75010
    - Not yet recruiting
    - Research Site
  - Paris, France, 75015
    - Not yet recruiting
    - Research Site
  - Poitiers, France, 86021
    - Not yet recruiting
    - Research Site
  - Reims, France, 51092
    - Not yet recruiting
    - Research Site
  - Rennes Cedex 9, France, 35033
    - Not yet recruiting
    - Research Site
  - Strasbourg Cedex, France, 67091
    - Not yet recruiting
    - Research Site
  - TOURS Cedex 9, France, 37044
    - Not yet recruiting
    - Research Site
  - Toulon, France, 83100
    - Not yet recruiting
    - Research Site
  - Toulouse, France, 31059
    - Not yet recruiting
    - Research Site
  - Valenciennes, France, 59300
    - Not yet recruiting
    - Research Site
Germany
- - Bad Nauheim, Germany, 61231
    - Not yet recruiting
    - Research Site
  - Bechhofen, Germany, 66894
    - Not yet recruiting
    - Research Site
  - Bernau bei Berlin, Germany, 16321
    - Not yet recruiting
    - Research Site
  - Chemnitz, Germany, 9113
    - Not yet recruiting
    - Research Site
  - Coburg, Germany, 96450
    - Not yet recruiting
    - Research Site
  - Dresden, Germany, 1307
    - Not yet recruiting
    - Research Site
  - Dresden, Germany, 01099
    - Not yet recruiting
    - Research Site
  - Elsterwerda, Germany, 04910
    - Not yet recruiting
    - Research Site
  - Frankfurt, Germany, 60590
    - Not yet recruiting
    - Research Site
  - Freiburg, Germany, 79106
    - Not yet recruiting
    - Research Site
  - Hagen, Germany, 58135
    - Not yet recruiting
    - Research Site
  - Hamburg, Germany, 20246
    - Not yet recruiting
    - Research Site
  - Hamburg, Germany, 22457
    - Not yet recruiting
    - Research Site
  - Kaiserslautern, Germany, 67655
    - Not yet recruiting
    - Research Site
  - Köln, Germany, 50733
    - Not yet recruiting
    - Research Site
  - Langen, Germany, 63225
    - Not yet recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Not yet recruiting
    - Research Site
  - Leverkusen, Germany, 51375
    - Not yet recruiting
    - Research Site
  - Mainz, Germany, 55131
    - Withdrawn
    - Research Site
  - Mönchengladbach, Germany, 41063
    - Not yet recruiting
    - Research Site
  - Papenburg, Germany, 26871
    - Not yet recruiting
    - Research Site
  - Regensburg, Germany, 93053
    - Not yet recruiting
    - Research Site
  - Remscheid, Germany, 42859
    - Not yet recruiting
    - Research Site
  - Rostock, Germany, 18059
    - Not yet recruiting
    - Research Site
  - Völklingen, Germany, 66333
    - Not yet recruiting
    - Research Site
  - Wermsdorf, Germany, 04779
    - Not yet recruiting
    - Research Site
  - Witten, Germany, 58455
    - Not yet recruiting
    - Research Site
Greece
- - Athens, Greece, 11521
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 11527
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 12462
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 11526
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 14233
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 15123
    - Not yet recruiting
    - Research Site
  - Dragana, Greece, 68100
    - Not yet recruiting
    - Research Site
  - Heraklio, Greece, 71110
    - Not yet recruiting
    - Research Site
  - Thessaloniki, Greece, 54636
    - Not yet recruiting
    - Research Site
  - Thessaloniki, Greece, 54642
    - Not yet recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1145
    - Not yet recruiting
    - Research Site
  - Budapest, Hungary, 1122
    - Not yet recruiting
    - Research Site
  - Békéscsaba, Hungary, 5600
    - Not yet recruiting
    - Research Site
  - Gyula, Hungary, 5700
    - Not yet recruiting
    - Research Site
  - Hódmezővásárhely, Hungary, 6800
    - Not yet recruiting
    - Research Site
  - Kecskemét, Hungary, 6000
    - Not yet recruiting
    - Research Site
  - Orosháza, Hungary, 5900
    - Not yet recruiting
    - Research Site
  - Pécs, Hungary, 7635
    - Not yet recruiting
    - Research Site
  - Pécs, Hungary, 7623
    - Not yet recruiting
    - Research Site
  - Székesfehérvár, Hungary, 8000
    - Not yet recruiting
    - Research Site
Israel
- - Afula, Israel, 1834111
    - Not yet recruiting
    - Research Site
  - Ashkelon, Israel, 78278
    - Not yet recruiting
    - Research Site
  - Be'er Ya'akov, Israel, 70300
    - Not yet recruiting
    - Research Site
  - Beer Sheva, Israel, 8410101
    - Not yet recruiting
    - Research Site
  - Haifa, Israel, 3109601
    - Not yet recruiting
    - Research Site
  - Holon, Israel, 5840608
    - Not yet recruiting
    - Research Site
  - Jerusalem, Israel, 00000
    - Not yet recruiting
    - Research Site
  - Kfar-Saba, Israel, 4428164
    - Not yet recruiting
    - Research Site
  - Nahariya, Israel, 22100
    - Not yet recruiting
    - Research Site
  - Petah Tikva, Israel, 49372
    - Not yet recruiting
    - Research Site
  - Tel Aviv, Israel, 6423906
    - Not yet recruiting
    - Research Site
  - Tiberias, Israel, 15208
    - Not yet recruiting
    - Research Site
Italy
- - Acquaviva delle Fonti, Italy, 70021
    - Not yet recruiting
    - Research Site
  - Bari, Italy, 70124
    - Not yet recruiting
    - Research Site
  - Bergamo, Italy, 24127
    - Not yet recruiting
    - Research Site
  - Brescia, Italy, 25100
    - Not yet recruiting
    - Research Site
  - Catanzaro, Italy, 88100
    - Not yet recruiting
    - Research Site
  - Cona, Italy, 44124
    - Not yet recruiting
    - Research Site
  - Cortona, Italy, 52044
    - Not yet recruiting
    - Research Site
  - Firenze, Italy, 50134
    - Not yet recruiting
    - Research Site
  - Milan, Italy, 20138
    - Not yet recruiting
    - Research Site
  - Novara, Italy, 28100
    - Withdrawn
    - Research Site
  - Pavia, Italy, 27100
    - Not yet recruiting
    - Research Site
  - San Giovanni Rotondo, Italy, 71013
    - Withdrawn
    - Research Site
Japan
- - Fujisawa-shi, Japan, 251-8550
    - Not yet recruiting
    - Research Site
  - Fukuoka-Shi, Japan, 812-8582
    - Not yet recruiting
    - Research Site
  - Fukutsu-shi, Japan, 811-3298
    - Not yet recruiting
    - Research Site
  - Hakusan-shi, Japan, 924-8588
    - Not yet recruiting
    - Research Site
  - Himeji, Japan, 670-8560
    - Not yet recruiting
    - Research Site
  - Iwakuni-shi, Japan, 740-8510
    - Not yet recruiting
    - Research Site
  - Kanonji-shi, Japan, 769-1695
    - Not yet recruiting
    - Research Site
  - Kasugai-shi, Japan, 486-8510
    - Not yet recruiting
    - Research Site
  - Kawaguchi, Japan, 333-0842
    - Not yet recruiting
    - Research Site
  - Kawanishi-shi, Japan, 666-0125
    - Not yet recruiting
    - Research Site
  - Kishiwada-shi, Japan, 596-8522
    - Not yet recruiting
    - Research Site
  - Kitakyusyu-shi, Japan, 806-8501
    - Not yet recruiting
    - Research Site
  - Kobe-shi, Japan, 654-0155
    - Not yet recruiting
    - Research Site
  - Kochi-shi, Japan, 780-8535
    - Not yet recruiting
    - Research Site
  - Maebashi-shi, Japan, 371-8511
    - Not yet recruiting
    - Research Site
  - Matsumoto-shi, Japan, 390-8621
    - Not yet recruiting
    - Research Site
  - Mito-shi, Japan, 311-4198
    - Recruiting
    - Research Site
  - Moriyama-shi, Japan, 524-8524
    - Not yet recruiting
    - Research Site
  - Nagoya-shi, Japan, 460-0001
    - Not yet recruiting
    - Research Site
  - Oita-shi, Japan, 870-8511
    - Not yet recruiting
    - Research Site
  - Osaka-shi, Japan, 540-0006
    - Not yet recruiting
    - Research Site
  - Osaka-shi, Japan, 543-0035
    - Not yet recruiting
    - Research Site
  - Sagamihara-shi, Japan, 252-5188
    - Not yet recruiting
    - Research Site
  - Saitama shi, Japan, 336 8522
    - Not yet recruiting
    - Research Site
  - Saitama-shi, Japan, 339-0033
    - Withdrawn
    - Research Site
  - Sakai-shi, Japan, 599-8247
    - Not yet recruiting
    - Research Site
  - Sakata City, Japan, 998-8501
    - Not yet recruiting
    - Research Site
  - Sanyoonoda-shi, Japan, 756-0095
    - Not yet recruiting
    - Research Site
  - Toshima-ku, Japan, 171-0014
    - Not yet recruiting
    - Research Site
  - Toyota City, Japan, 470-0396
    - Not yet recruiting
    - Research Site
  - Tsuchiura-shi, Japan, 300-0028
    - Not yet recruiting
    - Research Site
  - Ueda-shi, Japan, 386-8610
    - Recruiting
    - Research Site
  - Uji-shi, Japan, 611-0041
    - Not yet recruiting
    - Research Site
  - Uwajima-shi, Japan, 798-8510
    - Not yet recruiting
    - Research Site
  - Yanagawa-shi, Japan, 832-0077
    - Not yet recruiting
    - Research Site
  - Yokohama-shi, Japan, 221-0855
    - Not yet recruiting
    - Research Site
Korea, Republic of
- - Busan, Korea, Republic of, 49241
    - Not yet recruiting
    - Research Site
  - Seongnam-si, Korea, Republic of, 13620
    - Not yet recruiting
    - Research Site
  - Seoul, Korea, Republic of, 03722
    - Not yet recruiting
    - Research Site
  - Wonju-si, Korea, Republic of, 26426
    - Not yet recruiting
    - Research Site
Malaysia
- - Kajang, Malaysia, 43000
    - Not yet recruiting
    - Research Site
  - Kota Kinabalu, Malaysia, 88300
    - Not yet recruiting
    - Research Site
  - Kota Samarahan, Malaysia, 94300
    - Not yet recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 50400
    - Not yet recruiting
    - Research Site
  - Kuala Terengganu, Malaysia, 20400
    - Not yet recruiting
    - Research Site
  - Kuantan, Malaysia, 25200
    - Not yet recruiting
    - Research Site
  - Sungai Buloh, Malaysia, 47000
    - Not yet recruiting
    - Research Site
Mexico
- - Aguascalientes, Mexico, 20230
    - Not yet recruiting
    - Research Site
  - Chihuahua, Mexico, 31203
    - Not yet recruiting
    - Research Site
  - Cuauhtémoc, Mexico, 06700
    - Not yet recruiting
    - Research Site
  - Culiacán, Mexico, 80200
    - Not yet recruiting
    - Research Site
  - Guadalajara, Mexico, 44670
    - Not yet recruiting
    - Research Site
  - Mazatlán, Mexico, 82110
    - Not yet recruiting
    - Research Site
  - Metepec, Mexico, 52170
    - Not yet recruiting
    - Research Site
  - Mexico, Mexico, 14080
    - Not yet recruiting
    - Research Site
  - Mexico, Mexico, 07020
    - Not yet recruiting
    - Research Site
  - Mexico City, Mexico, 03310
    - Not yet recruiting
    - Research Site
  - Mexico City, Mexico, 07300
    - Not yet recruiting
    - Research Site
  - Monterey, Mexico, 64060
    - Not yet recruiting
    - Research Site
  - Morelia, Mexico, 58260
    - Not yet recruiting
    - Research Site
  - México, Mexico, 11650
    - Not yet recruiting
    - Research Site
  - Querétaro, Mexico, 76000
    - Not yet recruiting
    - Research Site
  - San Luis Potosí, Mexico, 78250
    - Not yet recruiting
    - Research Site
  - Tijuana, Mexico, 22014
    - Not yet recruiting
    - Research Site
  - Veracruz, Mexico, 91910
    - Not yet recruiting
    - Research Site
  - Xalapa, Mexico, 91193
    - Not yet recruiting
    - Research Site
Netherlands
- - Amsterdam, Netherlands, 1091 AC
    - Not yet recruiting
    - Research Site
  - Arnhem, Netherlands, 6815 AD
    - Not yet recruiting
    - Research Site
  - Emmen, Netherlands, 7824 AA
    - Not yet recruiting
    - Research Site
  - Goes, Netherlands, 4462 RA
    - Not yet recruiting
    - Research Site
  - Groningen, Netherlands, 9728 NT
    - Not yet recruiting
    - Research Site
  - Hardenberg, Netherlands, 7772 SE
    - Not yet recruiting
    - Research Site
Peru
- - Bellavista, Peru, CALLAO 2
    - Not yet recruiting
    - Research Site
  - Lima, Peru, LIMA 11
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15046
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15088
    - Not yet recruiting
    - Research Site
  - Lima, Peru, L18
    - Not yet recruiting
    - Research Site
  - Lima, Peru, LIMA 27
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15072
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15024
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15131
    - Not yet recruiting
    - Research Site
  - Lima, Peru, LIMA 41
    - Not yet recruiting
    - Research Site
  - Piura, Peru, 20001
    - Not yet recruiting
    - Research Site
Philippines
- - Angeles City, Philippines, 2009
    - Not yet recruiting
    - Research Site
  - Cebu City, Philippines, 6000
    - Not yet recruiting
    - Research Site
  - Davao City, Philippines, 8000
    - Not yet recruiting
    - Research Site
  - Davao City, Philippines, PH-8000
    - Not yet recruiting
    - Research Site
  - Iloilo City, Philippines, 5000
    - Not yet recruiting
    - Research Site
  - Las Pinas City, Philippines, PH-1704
    - Not yet recruiting
    - Research Site
  - Mabalacat, Philippines, 2023
    - Not yet recruiting
    - Research Site
  - Manadaluyong City, Philippines, 1552
    - Not yet recruiting
    - Research Site
  - Manila, Philippines, 1008
    - Not yet recruiting
    - Research Site
  - Marikina, Philippines, 1800
    - Not yet recruiting
    - Research Site
  - Pasig City, Philippines, 1605
    - Not yet recruiting
    - Research Site
  - Quezon City, Philippines, 1101
    - Not yet recruiting
    - Research Site
  - Quezon City, Philippines, 1112
    - Not yet recruiting
    - Research Site
  - Roxas City, Philippines, 5800
    - Not yet recruiting
    - Research Site
  - Taguig City, Philippines, 1634
    - Not yet recruiting
    - Research Site
  - West San Juan City, Philippines, 1502
    - Not yet recruiting
    - Research Site
Poland
- - Biała Podlaska, Poland, 21-500
    - Not yet recruiting
    - Research Site
  - Białystok, Poland, 15-481
    - Not yet recruiting
    - Research Site
  - Bielsko-Biała, Poland, 43-316
    - Not yet recruiting
    - Research Site
  - Bydgoszcz, Poland, 85-605
    - Not yet recruiting
    - Research Site
  - Bydgoszcz, Poland, 85-794
    - Not yet recruiting
    - Research Site
  - Chrzanów, Poland, 32-500
    - Not yet recruiting
    - Research Site
  - Gdynia, Poland, 81-157
    - Not yet recruiting
    - Research Site
  - Kazimierza Wielka, Poland, 28-500
    - Not yet recruiting
    - Research Site
  - Kraków, Poland, 30-688
    - Not yet recruiting
    - Research Site
  - Kraków, Poland, 31-513
    - Not yet recruiting
    - Research Site
  - Kraków, Poland, 30-082
    - Not yet recruiting
    - Research Site
  - Kędzierzyn-Koźle, Poland, 47-200
    - Not yet recruiting
    - Research Site
  - Lublin, Poland, 20-044
    - Not yet recruiting
    - Research Site
  - Lublin, Poland, 20-857
    - Not yet recruiting
    - Research Site
  - Olsztyn, Poland, 10-010
    - Not yet recruiting
    - Research Site
  - Piekary Śląskie, Poland, 41-940
    - Not yet recruiting
    - Research Site
  - Poznań, Poland, 61- 848
    - Not yet recruiting
    - Research Site
  - Rzeszow, Poland, 35-055
    - Not yet recruiting
    - Research Site
  - Rzeszów, Poland, 35-205
    - Not yet recruiting
    - Research Site
  - Szczecin, Poland, 71-526
    - Not yet recruiting
    - Research Site
  - Tarnów, Poland, 33-100
    - Not yet recruiting
    - Research Site
  - Toruń, Poland, 87-100
    - Not yet recruiting
    - Research Site
  - Tychy, Poland, 43-100
    - Not yet recruiting
    - Research Site
  - Warszawa, Poland, 00-416
    - Not yet recruiting
    - Research Site
  - Warszawa, Poland, 04-501
    - Not yet recruiting
    - Research Site
  - Zabrze, Poland, 41-800
    - Not yet recruiting
    - Research Site
  - Łódź, Poland, 93-513
    - Not yet recruiting
    - Research Site
  - Łódź, Poland, 91-053
    - Not yet recruiting
    - Research Site
  - Łódź, Poland, 90-549
    - Not yet recruiting
    - Research Site
  - Łódź, Poland, 94-046
    - Not yet recruiting
    - Research Site
Romania
- - Bucharest, Romania, 014461
    - Not yet recruiting
    - Research Site
  - Bucharest, Romania, 040883
    - Not yet recruiting
    - Research Site
  - Bucuresti, Romania, 022328
    - Not yet recruiting
    - Research Site
  - Cluj-Napoca, Romania, 400437
    - Not yet recruiting
    - Research Site
  - Iasi, Romania, 700503
    - Not yet recruiting
    - Research Site
  - Targu Mures, Romania, 540136
    - Not yet recruiting
    - Research Site
  - Targu Mures, Romania, 540099
    - Not yet recruiting
    - Research Site
  - Timisoara, Romania, 300595
    - Not yet recruiting
    - Research Site
  - Timișoara, Romania, 300310
    - Not yet recruiting
    - Research Site
Slovakia
- - Banska Bystrica, Slovakia, 974 01
    - Not yet recruiting
    - Research Site
  - Bratislava, Slovakia, 831 01
    - Not yet recruiting
    - Research Site
  - Brezno, Slovakia, 977 01
    - Not yet recruiting
    - Research Site
  - Kosice, Slovakia, 04022
    - Not yet recruiting
    - Research Site
  - Martin, Slovakia, 036 01
    - Not yet recruiting
    - Research Site
  - Myjava, Slovakia, 90701
    - Not yet recruiting
    - Research Site
  - Nitra, Slovakia, 949 01
    - Not yet recruiting
    - Research Site
  - Nove Zamky, Slovakia, 940 01
    - Not yet recruiting
    - Research Site
  - Považská Bystrica, Slovakia, 017 01
    - Not yet recruiting
    - Research Site
  - Presov, Slovakia, 080 01
    - Not yet recruiting
    - Research Site
  - Prešov, Slovakia, 080 01
    - Not yet recruiting
    - Research Site
  - Rimavska Sobota, Slovakia, 979 01
    - Not yet recruiting
    - Research Site
  - Svidník, Slovakia, 08901
    - Not yet recruiting
    - Research Site
South Africa
- - Panorama, South Africa, 7500
    - Not yet recruiting
    - Research Site
Spain
- - A Coruña, Spain, 15006
    - Not yet recruiting
    - Research Site
  - Barcelona, Spain, 08035
    - Not yet recruiting
    - Research Site
  - Barcelona, Spain, 08036
    - Not yet recruiting
    - Research Site
  - Barcelona, Spain, 08025
    - Not yet recruiting
    - Research Site
  - Lugo, Spain, 27004
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28027
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28007
    - Not yet recruiting
    - Research Site
  - Majadahonda, Spain, 28222
    - Not yet recruiting
    - Research Site
  - Sevilla, Spain, 41009
    - Not yet recruiting
    - Research Site
  - Sevilla, Spain, 41014
    - Not yet recruiting
    - Research Site
Sweden
- - Alingsås, Sweden, 441 83
    - Withdrawn
    - Research Site
  - Göteborg, Sweden, 413 46
    - Not yet recruiting
    - Research Site
  - Helsingborg, Sweden, 252 23
    - Not yet recruiting
    - Research Site
  - Jönköping, Sweden, 551 85
    - Not yet recruiting
    - Research Site
  - Karlstad, Sweden, 651 85
    - Not yet recruiting
    - Research Site
  - Lund, Sweden, 22242
    - Not yet recruiting
    - Research Site
  - Molndal, Sweden, SE431 80
    - Not yet recruiting
    - Research Site
  - Stockholm, Sweden, 118 83
    - Not yet recruiting
    - Research Site
  - Stockholm, Sweden, 171 64
    - Not yet recruiting
    - Research Site
  - Stockholm, Sweden, 112 81
    - Not yet recruiting
    - Research Site
  - Uppsala, Sweden, 75185
    - Not yet recruiting
    - Research Site
  - Västerås, Sweden, 723 35
    - Not yet recruiting
    - Research Site
Taiwan
- - Changhua, Taiwan, 500
    - Not yet recruiting
    - Research Site
  - Kaohsiung, Taiwan, 81362
    - Not yet recruiting
    - Research Site
  - Kaohsiung, Taiwan, 80756
    - Recruiting
    - Research Site
  - New Taipei, Taiwan, 220
    - Not yet recruiting
    - Research Site
  - New Taipei, Taiwan, 231
    - Not yet recruiting
    - Research Site
  - New Taipei City, Taiwan, 25160
    - Not yet recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Not yet recruiting
    - Research Site
  - Taichung, Taiwan, 433
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 0116
    - Not yet recruiting
    - Research Site
  - Taipei, Taiwan, 11101
    - Not yet recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Not yet recruiting
    - Research Site
  - Taipei, Taiwan, 11217
    - Not yet recruiting
    - Research Site
  - Taipei, Taiwan, 10449
    - Not yet recruiting
    - Research Site
  - Taipei, Taiwan, TAIWAN
    - Not yet recruiting
    - Research Site
  - Taipei City, Taiwan, 110
    - Not yet recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Not yet recruiting
    - Research Site
  - Yilan, Taiwan, 260
    - Not yet recruiting
    - Research Site
  - Yung Kang City, Taiwan, 71044
    - Not yet recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10330
    - Not yet recruiting
    - Research Site
  - Bangkok, Thailand, 10400
    - Not yet recruiting
    - Research Site
  - Chiang Mai, Thailand, 50200
    - Not yet recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Not yet recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Not yet recruiting
    - Research Site
  - Naimuang, Thailand, 30000
    - Not yet recruiting
    - Research Site
  - Pathumthani, Thailand, 12120
    - Not yet recruiting
    - Research Site
Turkey
- - Adana, Turkey, 01060
    - Not yet recruiting
    - Research Site
  - Ankara, Turkey, 06
    - Not yet recruiting
    - Research Site
  - Antalya, Turkey, 07059
    - Not yet recruiting
    - Research Site
  - Antalya, Turkey, 07100
    - Not yet recruiting
    - Research Site
  - Bursa, Turkey, 16059
    - Not yet recruiting
    - Research Site
  - Dinar, Turkey, 03400
    - Not yet recruiting
    - Research Site
  - Eskisehir, Turkey, 26480
    - Not yet recruiting
    - Research Site
  - Istanbul, Turkey, 34668
    - Not yet recruiting
    - Research Site
  - Izmir, Turkey, 35340
    - Not yet recruiting
    - Research Site
  - Kocaeli, Turkey, 41380
    - Not yet recruiting
    - Research Site
  - Kütahya, Turkey, 43100
    - Not yet recruiting
    - Research Site
  - Merkez, Turkey, 78200
    - Not yet recruiting
    - Research Site
  - Mugla, Turkey, 48000
    - Not yet recruiting
    - Research Site
  - Sivas, Turkey, 58140
    - Not yet recruiting
    - Research Site
United Kingdom
- - Airdrie, United Kingdom, ML6 0JS
    - Not yet recruiting
    - Research Site
  - Barnet, United Kingdom, EN5 3DJ
    - Not yet recruiting
    - Research Site
  - Cambridge, United Kingdom, CB2 0AY
    - Not yet recruiting
    - Research Site
  - Chertsey, United Kingdom, KT16 0PZ
    - Withdrawn
    - Research Site
  - Clydebank, United Kingdom, G81 4DY
    - Not yet recruiting
    - Research Site
  - Exeter, United Kingdom, EX2 5DW
    - Not yet recruiting
    - Research Site
  - Harefield, United Kingdom, UB9 6JH
    - Not yet recruiting
    - Research Site
  - Hastings, United Kingdom, TN37 7RD
    - Not yet recruiting
    - Research Site
  - High Wycombe, United Kingdom, HP11 2TT
    - Withdrawn
    - Research Site
  - King's Lynn, United Kingdom, PE30 4ET
    - Not yet recruiting
    - Research Site
  - Lincoln, United Kingdom, LN2 5QY
    - Not yet recruiting
    - Research Site
  - London, United Kingdom, EC1M 6BQ
    - Not yet recruiting
    - Research Site
  - London, United Kingdom, SE5 9RS
    - Not yet recruiting
    - Research Site
  - Middlesborough, United Kingdom, TS4 3BW
    - Not yet recruiting
    - Research Site
  - Portsmouth, United Kingdom, PO6 3LY
    - Not yet recruiting
    - Research Site
  - Sheffield, United Kingdom, S5 7AU
    - Not yet recruiting
    - Research Site
  - Sunderland, United Kingdom, SR4 7TP
    - Not yet recruiting
    - Research Site
  - Wakefield, United Kingdom, WF1 4DG
    - Not yet recruiting
    - Research Site
United States
- Alabama
  - Alexander City, Alabama, United States, 35010
    - Not yet recruiting
    - Research Site
  - Fairhope, Alabama, United States, 36532
    - Not yet recruiting
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Recruiting
    - Research Site
- California
  - Los Angeles, California, United States, 90089
    - Not yet recruiting
    - Research Site
  - Newport Beach, California, United States, 92663
    - Not yet recruiting
    - Research Site
  - San Diego, California, United States, 92123
    - Not yet recruiting
    - Research Site
  - San Francisco, California, United States, 94121
    - Not yet recruiting
    - Research Site
  - Santa Ana, California, United States, 92704
    - Not yet recruiting
    - Research Site
  - Thousand Oaks, California, United States, 91360
    - Not yet recruiting
    - Research Site
- Florida
  - Altamonte Springs, Florida, United States, 32701
    - Not yet recruiting
    - Research Site
  - Clearwater, Florida, United States, 33756
    - Not yet recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32209
    - Not yet recruiting
    - Research Site
  - Miami, Florida, United States, 33133
    - Not yet recruiting
    - Research Site
  - Saint Augustine, Florida, United States, 32086
    - Not yet recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Not yet recruiting
    - Research Site
  - Tucker, Georgia, United States, 30084
    - Not yet recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - Not yet recruiting
    - Research Site
  - Hazel Crest, Illinois, United States, 60429
    - Recruiting
    - Research Site
- Indiana
  - Hammond, Indiana, United States, 46324
    - Not yet recruiting
    - Research Site
  - Munster, Indiana, United States, 46321
    - Recruiting
    - Research Site
  - Richmond, Indiana, United States, 47374
    - Not yet recruiting
    - Research Site
- Kansas
  - Wichita, Kansas, United States, 67226
    - Not yet recruiting
    - Research Site
  - Wichita, Kansas, United States, 67218
    - Not yet recruiting
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Not yet recruiting
    - Research Site
- Louisiana
  - Alexandria, Louisiana, United States, 71301
    - Not yet recruiting
    - Research Site
  - Shreveport, Louisiana, United States, 71105
    - Not yet recruiting
    - Research Site
- Maine
  - Augusta, Maine, United States, 04330
    - Suspended
    - Research Site
- Michigan
  - Dearborn, Michigan, United States, 48126
    - Not yet recruiting
    - Research Site
  - Flint, Michigan, United States, 48504
    - Recruiting
    - Research Site
- Minnesota
  - Saint Paul, Minnesota, United States, 55102
    - Suspended
    - Research Site
- Missouri
  - Kansas City, Missouri, United States, 64128
    - Not yet recruiting
    - Research Site
- Nebraska
  - Lincoln, Nebraska, United States, 68506
    - Not yet recruiting
    - Research Site
- New Jersey
  - Somerset, New Jersey, United States, 08873
    - Not yet recruiting
    - Research Site
- New York
  - Bronx, New York, United States, 10455
    - Recruiting
    - Research Site
  - Buffalo, New York, United States, 14215
    - Not yet recruiting
    - Research Site
- North Carolina
  - Chapel Hill, North Carolina, United States, 27517
    - Not yet recruiting
    - Research Site
  - Greensboro, North Carolina, United States, 27405
    - Not yet recruiting
    - Research Site
- Ohio
  - Cincinnati, Ohio, United States, 45267
    - Not yet recruiting
    - Research Site
  - Maumee, Ohio, United States, 43537
    - Withdrawn
    - Research Site
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Not yet recruiting
    - Research Site
  - Camp Hill, Pennsylvania, United States, 17011
    - Not yet recruiting
    - Research Site
  - Hershey, Pennsylvania, United States, 17033
    - Not yet recruiting
    - Research Site
  - Horsham, Pennsylvania, United States, 19044
    - Not yet recruiting
    - Research Site
- Rhode Island
  - Providence, Rhode Island, United States, 02908
    - Not yet recruiting
    - Research Site
- South Carolina
  - Charleston, South Carolina, United States, 29401
    - Not yet recruiting
    - Research Site
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Not yet recruiting
    - Research Site
- Tennessee
  - Jackson, Tennessee, United States, 38305
    - Not yet recruiting
    - Research Site
  - Knoxville, Tennessee, United States, 37916
    - Not yet recruiting
    - Research Site
  - Memphis, Tennessee, United States, 38128
    - Not yet recruiting
    - Research Site
  - Nashville, Tennessee, United States, 37212
    - Not yet recruiting
    - Research Site
  - Tullahoma, Tennessee, United States, 37388
    - Not yet recruiting
    - Research Site
- Texas
  - Cypress, Texas, United States, 77429
    - Not yet recruiting
    - Research Site
  - El Paso, Texas, United States, 79905
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77002
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77025
    - Not yet recruiting
    - Research Site
  - Katy, Texas, United States, 77493
    - Not yet recruiting
    - Research Site
  - Odessa, Texas, United States, 79761
    - Not yet recruiting
    - Research Site
  - Sherman, Texas, United States, 75092
    - Not yet recruiting
    - Research Site
- Utah
  - Salt Lake City, Utah, United States, 84148
    - Not yet recruiting
    - Research Site
- Virginia
  - Falls Church, Virginia, United States, 22042
    - Recruiting
    - Research Site
  - Newport News, Virginia, United States, 23606
    - Not yet recruiting
    - Research Site
Vietnam
- - Da Nang, Vietnam, 550000
    - Not yet recruiting
    - Research Site
  - Ha Noi, Vietnam, 100000
    - Not yet recruiting
    - Research Site
  - Hai Phong, Vietnam, 180000
    - Not yet recruiting
    - Research Site
  - Hanoi, Vietnam, 100000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 70000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh city, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Hochiminh, Vietnam, 70000
    - Not yet recruiting
    - Research Site
  - Hochiminh city, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Hue, Vietnam, 530000
    - Not yet 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 ≥ 3.5 mmol/L and ≤ 5.0 mmol/L

Exclusion Criteria:

Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months
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 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 < 100 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
Hepatic disease, including active HBV or HCV infection, or other cause of hepatitis, and/or hepatic impairment (Child-Pugh class A-C), AST or ALT >3 × ULN; or TBL > 2 × ULN at time of screening
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

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 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D6402C00012

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

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Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Heart Failure and Impaired Kidney Function

Clinical Trials on balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg

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