Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND) (DIAMOND)

February 22, 2023 updated by: Vifor Pharma, Inc.

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)

The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.

Study Overview

Status

Completed

Conditions

Hyperkalemia

Intervention / Treatment

Detailed Description

Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and up to 12 weeks Run-in Phase (all subjects will have patiromer initiated and RAASi medications, including mineralocorticoid receptor antagonist (MRA) optimized) and a randomized withdrawal Blinded Treatment Phase.

The study population includes subjects with heart failure (HF) with reduced ejection fraction (HFrEF) who are hyperkalemic (serum potassium [K+] > 5.0 mEq/L) while receiving treatment with renin angiotensin aldosterone system inhibitor (RAASi) medications or who are normokalemic (serum K+ 4.0 - 5.0 mEq/L) but have a history of hyperkalemia prior to screening with subsequent reduction or discontinuation of a RAASi medication.

Each subject's participation includes a Run-in Phase (maximum 12 weeks) followed by the Treatment Phase (variable per subject). Study duration for individual subjects will vary, depending on their individual enrollment date. Subjects who prematurely discontinue patiromer/placebo will remain in the study for the collection of clinical events data and will receive usual care.

Study Type

Interventional

Enrollment (Actual)

1195

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 Locations

Argentina
- - Ciudad Autonoma de Buenos Aires, Argentina, 1425
    - Investigator Site 21-012
  - Ciudad Autonoma de Buenos Aires, Argentina, C1023AAB
    - Investigator Site 21-003
  - Ciudad Autonoma de Buenos Aires, Argentina, C1407GTN
    - Investigator Site 21-018
  - Ciudad Autonoma de Buenos Aires, Argentina, C1430CKE
    - Investigator Site 21-008
  - Salta, Argentina, A4406BPF
    - Investigator Site 21-017
  - San Luis, Argentina, 5700
    - Investigator Site 21-005
  - Santa Fe, Argentina, 3000
    - Investigator Site 21-009
- Buenos Aires
  - Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1093AAS
    - Investigator Site 21-006
  - Ciudadela, Buenos Aires, Argentina, B1702BML
    - Investigator Site 21-007
  - Ramos Mejía, Buenos Aires, Argentina, B1704ETD
    - Investigator Site 21-020
  - San Nicolás, Buenos Aires, Argentina, B2900DPA
    - Investigator Site 21-004
- Cordoba
  - Córdoba, Cordoba, Argentina, 5000
    - Investigator Site 21-011
  - Córdoba, Cordoba, Argentina, X5000EVQ
    - Investigator Site 21-021
  - Córdoba, Cordoba, Argentina, X5002AOQ
    - Investigator Site 21-014
  - Villa María, Cordoba, Argentina, 5900
    - Investigator Site 21-015
- Provincia De Buenos Aires
  - Mar Del Plata, Provincia De Buenos Aires, Argentina, B7602CBM
    - Investigator Site 21-019
- Tucuman
  - San Miguel De Tucumán, Tucuman, Argentina, 4000
    - Investigator Site 21-010
Belgium
- - Aalst, Belgium, B-9300
    - Investigator Site 44-005
  - Brussels, Belgium, 1200
    - Investigator Site 44-009
  - Genk, Belgium, 3600
    - Investigator Site 44-003
  - Hasselt, Belgium, 3500
    - Investigator Site 44-008
  - Leuven, Belgium, 3000
    - Investigator Site 44-007
  - Liège, Belgium, 4000
    - Investigator Site 44-006
  - Roeselare, Belgium, 8800
    - Investigator Site 44-010
  - Yvoir, Belgium, 5530
    - Investigator Site 44-004
- Antwerp
  - Mechelen, Antwerp, Belgium, 2800
    - Investigator Site 44-002
- Oost Vlaanderen
  - Ghent, Oost Vlaanderen, Belgium, 9000
    - Investigator Site 44-001
Brazil
- - Rio De Janeiro, Brazil, 20241-180
    - Investigator Site 22-024
  - São Paulo, Brazil, 05403-000
    - Investigator Site 22-014
  - São Paulo, Brazil, 09080-110
    - Investigator Site 22-022
- Bahia
  - Salvador, Bahia, Brazil, 40170-130
    - Investigator Site 22-021
- Ceará
  - Fortaleza, Ceará, Brazil, 60430-370
    - Investigator Site 22-019
  - Fortaleza, Ceará, Brazil, 60840-285
    - Investigator Site 22-013
- Distrito Federal
  - Brasília, Distrito Federal, Brazil, 70710-100
    - Investigator Site 22-023
- Espirito Santo
  - Vitória, Espirito Santo, Brazil, 29043-260
    - Investigator Site 22-012
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30110-934
    - Investigator Site 22-011
  - Belo Horizonte, Minas Gerais, Brazil, 30150-240
    - Investigator Site 22-005
  - Uberlândia, Minas Gerais, Brazil, 38411-186
    - Investigator Site 22-004
- Paraná
  - Campina Grande Do Sul, Paraná, Brazil, 83430-000
    - Investigator Site 22-010
- RS
  - Porto Alegre, RS, Brazil, 90020-090
    - Investigator Site 22-003
  - Porto Alegre, RS, Brazil, 90035-903
    - Investigator Site 22-015
  - Porto Alegre, RS, Brazil, 90620-001
    - Investigator Site 22-002
  - Porto Alegre, RS, Brazil, 91350-200
    - Investigator Site 22-025
- Rio Grande Do Sul
  - Canoas, Rio Grande Do Sul, Brazil, 92425-900
    - Investigator Site 22-008
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90840-440
    - Investigator Site 22-009
- SC
  - Blumenau, SC, Brazil, 89020-430
    - Investigator Site 22-017
- Sergipe
  - Aracaju, Sergipe, Brazil, 49055-530
    - Investigator Site 22-007
- São Paulo
  - Campinas, São Paulo, Brazil, 13083-970
    - Investigator Site 22-016
  - Ribeirão Preto, São Paulo, Brazil, 14051-140
    - Investigator Site 22-018
  - São José Do Rio Preto, São Paulo, Brazil, 15015-210
    - Investigator Site 22-020
Bulgaria
- - Burgas, Bulgaria, 8000
    - Investigator Site 61-003
  - Pleven, Bulgaria, 5800
    - Investigator Site 61-002
  - Plovdiv, Bulgaria, 4002
    - Investigator Site 61-004
  - Ruse, Bulgaria, 7002
    - Investigator Site 61-010
  - Sofia, Bulgaria, 1233
    - Investigator Site 61-009
  - Sofia, Bulgaria, 1379
    - Investigator Site 61-008
  - Sofia, Bulgaria, 1431
    - Investigator Site 61-005
  - Sofia, Bulgaria, 1527
    - Investigator Site 61-006
Canada
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - Investigator Site 12-005
- Newfoundland and Labrador
  - Saint John's, Newfoundland and Labrador, Canada, A1B3V6
    - Investigator Site 12-013
- Ontario
  - Cambridge, Ontario, Canada, N1R7R1
    - Investigator Site 12-008
  - London, Ontario, Canada, N6A 5A5
    - Investigator Site 12-012
  - Newmarket, Ontario, Canada, L3Y 2P6
    - Investigator Site 12-010
  - Toronto, Ontario, Canada, M5B 1W8
    - Investigator Site 12-002
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2G8
    - Investigator Site 12-009
  - Sherbrooke, Quebec, Canada, J1G 2E8
    - Investigator Site 12-006
  - Trois-Rivières, Quebec, Canada, G8Z 3R9
    - Investigator Site 12-004
Czechia
- - Brno, Czechia, 65691
    - Investigator Site 62-019
  - Bílina, Czechia, 41801
    - Investigator Site 62-004
  - Havlíčkův Brod, Czechia, 58022
    - Investigator Site 62-005
  - Havířov, Czechia, 73601
    - Investigator Site 62-017
  - Liberec, Czechia, 46001
    - Investigator Site 62-013
  - Litovel, Czechia, 78401
    - Investigator Site 62-015
  - Mariánské Lázně, Czechia, 35301
    - Investigator Site 62-010
  - Náchod, Czechia, 54701
    - Investigator Site 62-018
  - Praha, Czechia, 12808
    - Investigator Site 62-001
  - Praha, Czechia, 14059
    - Investigator Site 62-012
  - Praha, Czechia, 16902
    - Investigator Site 62-009
  - Slaný, Czechia, 27401
    - Investigator Site 62-011
  - Uherské Hradiště, Czechia, 68601
    - Investigator Site 62-016
France
- - Bordeaux, France, 33075
    - Investigator Site 32-010
  - La Tronche, France, 38700
    - Investigator Site 32-002
  - Lille, France, 59000
    - Investigator Site 32-014
  - Lyon, France, 76000
    - Investigator Site 32-020
  - Montpellier, France, 34295
    - Investigator Site 32-005
  - Nancy, France, 54500
    - Investigator Site 32-001
  - Paris, France, 75010
    - Investigator Site 32-004
  - Paris, France, 75013
    - Investigator Site 32-008
  - Paris, France, 75013
    - Investigator Site 32-017
  - Paris, France, 75018
    - Investigator Site 32-007
  - Pau, France, 64000
    - Investigator Site 32-003
  - Poitiers, France, 86021
    - Investigator Site 32-015
  - Reims, France, 51092
    - Investigator Site 32-013
  - Rouen, France, 76031
    - Investigator Site 32-019
  - Saint-Brieuc, France, 22000
    - Investigator Site 32-018
  - Toulon, France, 83100
    - Investigator Site 32-006
  - Toulouse, France, 31400
    - Investigator Site 32-012
  - Tourcoing, France, 59200
    - Investigator Site 32-009
  - Valenciennes, France, 59300
    - Investigator Site 32-011
  - Valenciennes, France, 59300
    - Investigator Site 32-016
Georgia
- - Batumi, Georgia, 6004
    - Investigator Site 63-012
  - Tbilisi, Georgia, 0102
    - Investigator Site 63-007
  - Tbilisi, Georgia, 0112
    - Investigator Site 63-011
  - Tbilisi, Georgia, 0131
    - Investigator Site 63-004
  - Tbilisi, Georgia, 0159
    - Investigator Site 63-002
  - Tbilisi, Georgia, 0159
    - Investigator Site 63-006
  - Tbilisi, Georgia, 0159
    - Investigator Site 63-008
  - Tbilisi, Georgia, 0159
    - Investigator Site 63-010
  - Tbilisi, Georgia, 0167
    - Investigator Site 63-003
  - Tbilisi, Georgia, 0172
    - Investigator Site 63-009
  - Tbilisi, Georgia, 0180
    - Investigator Site 63-001
  - Tbilisi, Georgia, 0186
    - Investigator Site 63-005
Germany
- - Bad Oeynhausen, Germany, 32545
    - Investigator Site 33-023
  - Berlin, Germany, 10789
    - Investigator Site 33-020
  - Berlin, Germany, 12559
    - Investigator Site 33-013
  - Bielefeld, Germany, 33604
    - Investigator Site 33-015
  - Bremen, Germany, 28277
    - Investigator Site 33-016
  - Erfurt, Germany, 99097
    - Investigator Site 33-004
  - Essen, Germany, 45138
    - Investigator Site 33-001
  - Frankfurt, Germany, 60590
    - Investigator Site 33-019
  - Frankfurt, Germany, 65929
    - Investigator Site 33-007
  - Gießen, Germany, 35392
    - Investigator Site 33-018
  - Halle, Germany, 06120
    - Investigator Site 33-002
  - Hamburg, Germany, 20246
    - Investigator Site 33-005
  - Hanover, Germany, 30625
    - Investigator Site 33-022
  - Heilbronn, Germany, 74177
    - Investigator Site 33-012
  - Kiel, Germany, 24105
    - Investigator Site 33-017
  - Leipzig, Germany, 04103
    - Investigator Site 33-021
  - Leverkusen, Germany, 51375
    - Investigator Site 33-010
  - Minden, Germany, 32429
    - Investigator Site 33-024
  - Nürnberg, Germany, 90402
    - Investigator Site 33-014
  - Würzburg, Germany, 97078
    - Investigator Site 33-003
- Bavarian
  - Coburg, Bavarian, Germany, 96450
    - Investigator Site 33-011
- Mecklenburg-Vorpommern
  - Greifswald, Mecklenburg-Vorpommern, Germany, 17475
    - Investigator Site 33-008
- Saar
  - Homburg, Saar, Germany, D-66421
    - Investigator Site 33-006
Hungary
- - Budapest, Hungary, 1096
    - Investigator Site 64-010
  - Budapest, Hungary, 1097
    - Investigator Site 64-002
  - Budapest, Hungary, 1122
    - Investigator Site 64-006
  - Budapest, Hungary, 1134
    - Investigator Site 64-009
  - Kecskemét, Hungary, 6000
    - Investigator Site 64-001
  - Kistarcsa, Hungary, 2143
    - Investigator Site 64-007
  - Nyiregyhaza, Hungary, 4400
    - Investigator Site 64-005
Israel
- - Ashqelon, Israel, 78278
    - Investigator Site 35-008
  - Be'er Ya'aqov, Israel, 6093000
    - Investigator Site 35-009
  - Hadera, Israel, 3810101
    - Investigator Site 35-003
  - Haifa, Israel, 3109601
    - Investigator Site 35-006
  - Haifa, Israel, 3109601
    - Investigator Site 35-007
  - H̱olon, Israel, 98100
    - Investigator Site 35-002
  - Jerusalem, Israel, 9103102
    - Investigator Site 35-005
  - Jerusalem, Israel, 91120
    - Investigator Site 35-014
  - Jerusalem, Israel, 91240
    - Investigator Site 35-001
  - Nahariya, Israel, 2210001
    - Investigator Site 35-010
  - Petah tikva, Israel, 4941492
    - Investigator Site 35-011
  - Ramat Gan, Israel, 5265601
    - Investigator Site 35-013
  - Safed, Israel, 13100
    - Investigator Site 35-012
  - Tiberias, Israel, 1520800
    - Investigator Site 35-016
Italy
- - Ancona, Italy
    - Investigator Site 34-005
  - Bergamo, Italy, 24127
    - Investigator Site 34-002
  - Brescia, Italy, 25123
    - Investigator Site 34-007
  - Caserta, Italy, 81100
    - Investigator Site 34-001
  - Cona, Italy, 44120
    - Investigator Site 34-009
  - Foggia, Italy, 71100
    - Investigator Site 34-014
  - Genova, Italy, 16132
    - Investigator Site 34-010
  - Milano, Italy, 20138
    - Investigator Site 34-004
  - Piacenza, Italy, 29121
    - Investigator Site 34-012
  - Roma, Italy, 00163
    - Investigator Site 34-003
  - San Bonifacio, Italy, 37047
    - Investigator Site 34-013
Mexico
- Ciudad De Mexico
  - Cuauhtémoc, Ciudad De Mexico, Mexico, 06090
    - Investigator Site 23-007
  - Delegación Gustavo A. Madero, Ciudad De Mexico, Mexico, 07020
    - Investigator Site 23-005
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44100
    - Investigator Site 23-012
  - Guadalajara, Jalisco, Mexico, 44657
    - Investigator Site 23-004
- Nuevo Léon
  - San Pedro Garza Garcia, Nuevo Léon, Mexico, 66278
    - Investigator Site 23-010
- Oaxaca
  - Oaxaca de Juarez, Oaxaca, Mexico, 6800
    - Investigator Site 23-011
- Querétaro
  - Santiago De Querétaro, Querétaro, Mexico, 76000
    - Investigator Site 23-001
- Sinaloa
  - Culiacán, Sinaloa, Mexico, 80230
    - Investigator Site 23-002
- Veracruz
  - Xalapa, Veracruz, Mexico, 91193
    - Investigator Site 23-006
Netherlands
- - 's-Hertogenbosch, Netherlands, 5223GZ
    - Investigator Site 36-002
  - Amstelveen, Netherlands, 1186AM
    - Investigator Site 36-012
  - Blaricum, Netherlands, 1261 AN
    - Investigator Site 36-006
  - Dirksland, Netherlands, 3247BW
    - Investigator Site 36-009
  - Dordrecht, Netherlands, 3318 AT
    - Investigator Site 36-015
  - Ede, Netherlands, 6716 RP
    - Investigator Site 36-007
  - Groningen, Netherlands, 9713 GZ
    - Investigator Site 36-001
  - Helmond, Netherlands, 5707HA
    - Investigator Site 36-013
  - Hoorn, Netherlands, 1624 NP
    - Investigator Site 36-014
  - Schiedam, Netherlands, 3118 JH
    - Investigator Site 36-010
  - Tilburg, Netherlands, 5042 AD
    - Investigator Site 36-004
  - Utrecht, Netherlands, 3582 KE
    - Investigator Site 36-011
- South Holland
  - Rotterdam, South Holland, Netherlands, 3000
    - Investigator Site 36-003
Poland
- - Białystok, Poland, 15-276
    - Investigator Site 65-007
  - Katowice, Poland, 40-156
    - Investigator Site 65-014
  - Kędzierzyn-Koźle, Poland, 47-200
    - Investigator Site 65-012
  - Olsztyn, Poland, 10-010
    - Investigator Site 65-019
  - Ostrowiec Świętokrzyski, Poland, 27-400
    - Investigator Site 65-015
  - Pomorskie, Poland, 81-717
    - Investigator Site 65-021
  - Poznań, Poland, 61-485
    - Investigator Site 65-003
  - Poznań, Poland, 61-848
    - Investigator Site 65-020
  - Rzeszów, Poland, 35-055
    - Investigator Site 65-008
  - Wrocław, Poland, 50-556
    - Investigator Site 65-010
  - Wrocław, Poland, 51-162
    - Investigator Site 65-005
  - Zgierz, Poland, 95-100
    - Investigator Site 65-011
  - Łódź, Poland, 90-549
    - Investigator Site 65-001
  - Łódź, Poland, 93-513
    - Investigator Site 65-018
Russian Federation
- - Chelyabinsk, Russian Federation, 454136
    - Investigator Site 66-008
  - Ekaterinburg, Russian Federation, 620109
    - Investigator Site 66-001
  - Kazan, Russian Federation, 420033
    - Investigator Site 66-016
  - Kemerovo, Russian Federation, 650002
    - Investigator Site 66-010
  - Moscow, Russian Federation, 111539
    - Investigator Site 66-015
  - Moscow, Russian Federation, 119192
    - Investigator Site 66-004
  - Moscow, Russian Federation, 119192
    - Investigator Site 66-011
  - Moscow, Russian Federation, 124489
    - Investigator Site 66-017
  - Novosibirsk, Russian Federation, 63008
    - Investigator Site 66-002
  - Penza, Russian Federation, 440026
    - Investigator Site 66-005
  - Perm, Russian Federation, 614097
    - Investigator Site 66-007
  - Petrozavodsk, Russian Federation, 185019
    - Investigator Site 66-012
  - Ryazan', Russian Federation, 390039
    - Investigator Site 66-018
  - Saint Petersburg, Russian Federation, 198205
    - Investigator Site 66-013
  - Saint Petersburg, Russian Federation, 199106
    - Investigator Site 66-003
  - Tver, Russian Federation, 170036
    - Investigator Site 66-009
- Udmurt Republic
  - Izhevsk, Udmurt Republic, Russian Federation, 426063
    - Investigator Site 66-014
Serbia
- - Belgrade, Serbia, 11000
    - Investigator Site 67-010
  - Belgrade, Serbia, 11040
    - Investigator Site 67-002
  - Belgrade, Serbia, 11050
    - Investigator Site 67-004
  - Belgrade, Serbia, 11080
    - Investigator Site 67-008
  - Niš, Serbia, 18000
    - Investigator Site 67-005
  - Niška Banja, Serbia, 18205
    - Investigator Site 67-007
  - Sremska Kamenica, Serbia, 21204
    - Investigator Site 67-001
  - Šabac, Serbia, 15000
    - Investigator Site 67-003
Spain
- - Alicante, Spain, 03010
    - Investigator Site 37-012
  - Badalona, Spain, 08916
    - Investigator Site 37-015
  - Barcelona, Spain, 08041
    - Investigator Site 37-007
  - Barcelona, Spain, 08907
    - Investigator Site 37-002
  - Huelva, Spain, 021005
    - Investigator Site 37-018
  - La Coruña, Spain
    - Investigator Site 37-025
  - Lleida, Spain, 25198
    - Investigator Site 37-023
  - Madrid, Spain, 028007
    - Investigator Site 37-004
  - Madrid, Spain, 028041
    - Investigator Site 37-006
  - Madrid, Spain, 28006
    - Investigator Site 37-021
  - Madrid, Spain, 28034
    - Investigator Site 37-020
  - Madrid, Spain, 28040
    - Investigator Site 37-026
  - Murcia, Spain, 300008
    - Investigator Site 37-022
  - Málaga, Spain, 29010
    - Investigator Site 37-017
  - Sevilla, Spain, 041007
    - Investigator Site 37-013
  - Valencia, Spain, 046020
    - Investigator Site 37-009
  - Valencia, Spain, 4610
    - Investigator Site 37-008
- Baleares
  - Palma De Mallorca, Baleares, Spain, 07120
    - Investigator Site 37-014
- Castellon
  - Castellón De La Plana, Castellon, Spain, 12004
    - Investigator Site 37-010
- Cataluña
  - Barcelona, Cataluña, Spain, 08003
    - Investigator Site 37-003
- La Coruña
  - Santiago De Compostela, La Coruña, Spain, 015706
    - Investigator Site 37-005
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Investigator Site 37-011
- Malaga
  - Marbella, Malaga, Spain, 029603
    - Investigator Site 37-024
- Tenerife
  - La Laguna, Tenerife, Spain, 038320
    - Investigator Site 37-016
- Valencia
  - Manises, Valencia, Spain, 46940
    - Investigator Site 37-001
Ukraine
- - Dnipro, Ukraine, 49027
    - Investigator Site 68-017
  - Ivano-Frankivs'k, Ukraine, 76008
    - Investigator Site 68-009
  - Ivano-Frankivs'k, Ukraine, 76018
    - Investigator Site 68-005
  - Kharkiv, Ukraine, 61039
    - Investigator Site 68-001
  - Kharkiv, Ukraine, 61058
    - Investigator Site 68-011
  - Kharkiv, Ukraine, 61103
    - Investigator Site 68-010
  - Kharkiv, Ukraine, 61176
    - Investigator Site 68-002
  - Kyiv, Ukraine, 01601
    - Investigator Site 68-012
  - Kyiv, Ukraine, 0200
    - Investigator Site 68-003
  - Kyiv, Ukraine, 02166
    - Investigator Site 68-015
  - Kyiv, Ukraine, 03110
    - Investigator Site 68-013
  - Kyiv, Ukraine, 04050
    - Investigator Site 68-007
  - Lviv, Ukraine, 79013
    - Investigator Site 68-006
  - Vinnytsia, Ukraine, 21000
    - Investigator Site 68-014
  - Zaporizhzhya, Ukraine, 69106
    - Investigator Site 68-016
  - Zhytomyr, Ukraine, 10002
    - Investigator Site 68-004
- Novobavarskiy
  - Kharkiv, Novobavarskiy, Ukraine, 61157
    - Investigator Site 68-008
United Kingdom
- - Barnsley, United Kingdom, S75 2EP
    - Investigator Site 39-009
  - High Wycombe, United Kingdom, HP11 2TT
    - Investigator Site 39-016
  - Inverness, United Kingdom, IV2 3JH
    - Investigator Site 39-008
  - Leicester, United Kingdom, LE3 9QP
    - Investigator Site 39-011
  - Liverpool, United Kingdom, L9 7AL
    - Investigator Site 39-013
  - London, United Kingdom, SE5 9RS
    - Investigator Site 39-015
  - North Shields, United Kingdom, NE29 8NH
    - Investigator Site 39-010
  - Swansea, United Kingdom, SA6 6NL
    - Investigator Site 39-007
  - York, United Kingdom, YO31 8HE
    - Investigator Site 39-004
- Essex
  - Harlow, Essex, United Kingdom, CM2 01QX
    - Investigator Site 39-012
- North Lincolshire
  - Scunthorpe, North Lincolshire, United Kingdom, DN15 7BH
    - Investigator Site 39-003
- West Midlands
  - Dudley, West Midlands, United Kingdom, DY1 2HQ
    - Investigator Site 39-005
United States
- Alabama
  - Alexander City, Alabama, United States, 35010
    - Investigator Site 11-080
  - Huntsville, Alabama, United States, 35801
    - Investigator Site 11-041
- Arizona
  - Phoenix, Arizona, United States, 85108
    - Investigator Site 11-153
  - Tucson, Arizona, United States, 85724
    - Investigator Site 11-097
- California
  - Bakersfield, California, United States, 93308
    - Investigator Site 11-052
  - Fremont, California, United States, 94538
    - Investigator Site 11-174
  - Fresno, California, United States, 93720
    - Investigator Site 11-136
  - Huntington Beach, California, United States, 92648
    - Investigator Site 11-102
  - La Jolla, California, United States, 92037
    - Investigator Site 11-162
  - La Mesa, California, United States, 91942
    - Investigator Site 11-048
  - Laguna Hills, California, United States, 92653
    - Investigator Site 11-111
  - Long Beach, California, United States, 90813
    - Investigator Site 11-017
  - Northridge, California, United States, 91324
    - Investigator Site 11-128
  - Pasadena, California, United States, 91105
    - Investigator Site 11-035
  - Sacramento, California, United States, 95816
    - Investigator Site 11-044
  - San Diego, California, United States, 92119
    - Investigator Site 11-135
  - San Diego, California, United States, 92161
    - Investigator Site 11-086
  - Santa Ana, California, United States, 92705
    - Investigator Site 11-112
  - Stockton, California, United States, 95204
    - Investigator Site 11-101
  - Thousand Oaks, California, United States, 91360
    - Investigator Site 11-047
  - Van Nuys, California, United States, 91401
    - Investigator Site 11-057
  - West Hills, California, United States, 91307
    - Investigator Site 11-058
- Colorado
  - Aurora, Colorado, United States, 80045
    - Investigator Site 11-095
- Florida
  - Altamonte Springs, Florida, United States, 32701
    - Investigator Site 11-168
  - Boynton Beach, Florida, United States, 33437
    - Investigator Site 11-106
  - Brandon, Florida, United States, 33511
    - Investigator Site 11-028
  - Doral, Florida, United States, 33166
    - Investigator Site 11-003
  - Gainesville, Florida, United States, 32608
    - Investigator Site 11-138
  - Greenacres City, Florida, United States, 33467
    - Investigator Site 11-164
  - Homestead, Florida, United States, 33033
    - Investigator Site 11-078
  - Jacksonville, Florida, United States, 32224-1865
    - Investigator Site 11-004
  - Jacksonville, Florida, United States, 32277
    - Investigator Site 11-179
  - Medley, Florida, United States, 33166
    - Investigator Site 11-122
  - Miami, Florida, United States, 33125
    - Investigator Site 11-115
  - Miami, Florida, United States, 33144
    - Investigator Site 11-125
  - Miami, Florida, United States, 33155
    - Investigator Site 11-005
  - Miami Lakes, Florida, United States, 33014
    - Research Site 11-001
  - Miami Lakes, Florida, United States, 33014
    - Research Site 11-002
  - North Miami Beach, Florida, United States, 33169
    - Investigator Site 11-032
  - Orlando, Florida, United States, 32807
    - Investigator Site 11-171
  - Orlando, Florida, United States, 32810
    - Investigator Site 11-025
  - Orlando, Florida, United States, 32819
    - Investigator Site 11-087
  - Pembroke Pines, Florida, United States, 33026
    - Investigator Site 11-177
  - Pompano Beach, Florida, United States, 33064
    - Investigator Site 11-144
  - Tamarac, Florida, United States, 33321
    - Investigator Site 11-099
  - Tampa, Florida, United States, 33606
    - Investigator Site 11-090
  - Tampa, Florida, United States, 33614
    - Investigator Site 11-163
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Investigator Site 11-109
  - Columbus, Georgia, United States, 31904
    - Investigator Site 11-015
  - Macon, Georgia, United States, 31201
    - Investigator Site 11-141
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Investigator Site 11-031
  - Hazel Crest, Illinois, United States, 60429
    - Investigator Site 11-051
  - Peoria, Illinois, United States, 61602
    - Investigator Site 11-063
  - Peoria, Illinois, United States, 61614
    - Investigator Site 11-137
- Indiana
  - Merrillville, Indiana, United States, 46410
    - Investigator Site 11-117
  - Munster, Indiana, United States, 46321
    - Investigator Site 11-129
  - Richmond, Indiana, United States, 47347
    - Investigator Site 11-069
- Kentucky
  - Owensboro, Kentucky, United States, 42303
    - Investigator Site 11-061
- Louisiana
  - Opelousas, Louisiana, United States, 70570
    - Investigator Site 11-183
  - West Monroe, Louisiana, United States, 71291
    - Investigator Site 11-022
- Maryland
  - Baltimore, Maryland, United States, 21229
    - Investigator Site 11-027
  - Columbia, Maryland, United States, 21044
    - Investigator Site 11-023
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Investigator Site 11-132
- Michigan
  - Detroit, Michigan, United States, 48201
    - Investigator Site 11-123
  - Livonia, Michigan, United States, 48154
    - Investigator Site 11-121
  - Rochester, Michigan, United States, 48307
    - Investigator Site 11-076
  - Rochester, Michigan, United States, 48307
    - Investigator Site 11-189
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Investigator Site 11-068
- Missouri
  - Kansas City, Missouri, United States, 64111
    - Investigator Site 11-154
  - Saint Louis, Missouri, United States, 63110
    - Investigator Site 11-094
- Nebraska
  - Lincoln, Nebraska, United States, 68256-9797
    - Investigator Site 11-071
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - Investigator Site 11-049
  - North Las Vegas, Nevada, United States, 89086
    - Investigator Site 11-145
- New Jersey
  - Haddon Heights, New Jersey, United States, 08035
    - Investigator Site 11-088
  - Linden, New Jersey, United States, 07036
    - Investigator Site 11-054
  - New Brunswick, New Jersey, United States, 08901
    - Investigator Site 11-148
  - Newark, New Jersey, United States, 07102
    - Investigator Site 11-107
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Investigator Site 11-116
- New York
  - Bronx, New York, United States, 10461
    - Investigator Site 11-127
  - Brooklyn, New York, United States, 11203-2012
    - Investigator Site 11-151
  - Brooklyn, New York, United States, 11234
    - Investigator Site 11-126
  - Buffalo, New York, United States, 14215-1145
    - Investigator Site 11-073
  - Manhasset, New York, United States, 11030
    - Investigator Site 11-040
  - Richmond Hill, New York, United States, 11419
    - Investigator Site 11-053
  - Staten Island, New York, United States, 10310
    - Investigator Site 11-081
  - Stony Brook, New York, United States, 11794
    - Investigator Site 11-021
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Investigator Site 11-120
  - Charlotte, North Carolina, United States, 28207
    - Investigator Site 11-075
  - Greenville, North Carolina, United States, 27834
    - Investigator Site 11-018
  - Lumberton, North Carolina, United States, 28358
    - Investigator Site 11-157
- Ohio
  - Columbus, Ohio, United States, 43214
    - Investigator Site 11-149
  - Lorain, Ohio, United States, 44053
    - Investigator Site 11-064
  - Marion, Ohio, United States, 43302-6416
    - Investigator Site 11-042
  - Toledo, Ohio, United States, 43623
    - Investigator Site 11-187
- Oklahoma
  - Bartlesville, Oklahoma, United States, 74006
    - Investigator Site 11-074
  - Oklahoma City, Oklahoma, United States, 73112
    - Investigator Site 11-124
- Oregon
  - Hillsboro, Oregon, United States, 97123
    - Investigator Site 11-056
  - Portland, Oregon, United States, 97239
    - Investigator Site 11-169
- Pennsylvania
  - Erie, Pennsylvania, United States, 16507
    - Investigator Site 11-165
  - Hershey, Pennsylvania, United States, 17033
    - Investigator Site 11-082
- South Carolina
  - Greenville, South Carolina, United States, 29607
    - Investigator Site 11-110
  - Greenwood, South Carolina, United States, 29646
    - Investigator Site 11-098
  - Lancaster, South Carolina, United States, 29720
    - Investigator Site 11-119
  - Rock Hill, South Carolina, United States, 29732
    - Investigator Site 11-133
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Investigator Site 11-152
  - Jackson, Tennessee, United States, 38301
    - Investigator Site 11-091
  - Memphis, Tennessee, United States, 38117
    - Investigator Site 11-142
  - Memphis, Tennessee, United States, 38138
    - Investigator Site 11-083
  - Tullahoma, Tennessee, United States, 37388
    - Investigator Site 11-134
- Texas
  - Allen, Texas, United States, 75013
    - Investigator Site 11-104
  - Allen, Texas, United States, 75013
    - Investigator Site 11-185
  - Amarillo, Texas, United States, 79106
    - Investigator Site 11-070
  - Dallas, Texas, United States, 75231
    - Investigator Site 11-176
  - Dallas, Texas, United States, 75246
    - Investigator Site 11-092
  - Denison, Texas, United States, 75020
    - Investigator Site 11-170
  - Fort Worth, Texas, United States, 76104
    - Investigator Site 11-060
  - Gonzales, Texas, United States, 78629
    - Investigator Site 11-072
  - Houston, Texas, United States, 77002
    - Investigator Site 11-140
  - Houston, Texas, United States, 77070
    - Investigator Site 11-089
  - Houston, Texas, United States, 77077
    - Investigator Site 11-146
  - Houston, Texas, United States, 77094
    - Investigator Site 11-156
  - Katy, Texas, United States, 77450
    - Investigator Site 11-034
  - Lampasas, Texas, United States, 76550
    - Investigator Site 11-029
  - McKinney, Texas, United States, 75071
    - Investigator Site 11-046
  - San Antonio, Texas, United States, 78215
    - Investigator Site 11-147
  - San Antonio, Texas, United States, 78229
    - Investigator Site 11-085
  - Sugar Land, Texas, United States, 77479
    - Investigator Site 11-161
  - Webster, Texas, United States, 77598
    - Investigator Site 11-160
- Utah
  - Salt Lake City, Utah, United States, 84132
    - Investigator Site 11-178
- Virginia
  - Norfolk, Virginia, United States, 23507
    - Investigator Site 11-158
  - Norfolk, Virginia, United States, 23510
    - Investigator Site 11-188
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Investigator Site 11-065
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Investigator Site 11-045

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age at least 18 years or greater
Symptomatic low ejection fraction heart failure (weak heart muscle)
Receiving any dose of a beta blocker for the treatment of HF (unless not able to tolerate)
Kidney function not more than mild or moderately impaired
High blood potassium (>5.0 mEq/L) currently while receiving medications for heart failure OR normal blood potassium currently but previously had high potassium in the12 months prior to screening which caused a permanent reduction or discontinuation of heart failure medications
Hospitalization for heart failure or treatment in an out patient setting with intravenous medications within the last 12 months before screening.

Exclusion Criteria:

Current acute decompensated HF, within 4 weeks before screening. Subjects with a discharge from a hospitalization for acute decompensation of HF longer than 4 weeks before screening may be included
Significant primary aortic or mitral valvular heart disease (except secondary mitral regurgitation due to left ventricular dilatation)
Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant waiting list) during the study period

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: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Patiromer Subjects will be randomized to receive a daily dose of patiromer with possible dose adjustments based on subsequent local serum potassium levels.	Drug: Patiromer The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose). Other Names: Veltassa
Placebo Comparator: Group 2: Placebo Subjects will be randomized to receive a daily dose of placebo with possible dose adjustments based on subsequent local serum potassium levels.	Drug: Placebos The starting dose of placebo will be 1 packet/day and may be taken either with food or without food. Based upon the placebo treatment algorithm placebo may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, placebo may be decreased to a minimum of 0 packets/day. Doses of placebo will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Participant Group / Arm

Intervention / Treatment

Experimental: Group 1: Patiromer

Subjects will be randomized to receive a daily dose of patiromer with possible dose adjustments based on subsequent local serum potassium levels.

Drug: Patiromer

The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Other Names:

Veltassa

Placebo Comparator: Group 2: Placebo

Subjects will be randomized to receive a daily dose of placebo with possible dose adjustments based on subsequent local serum potassium levels.

Drug: Placebos

The starting dose of placebo will be 1 packet/day and may be taken either with food or without food. Based upon the placebo treatment algorithm placebo may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, placebo may be decreased to a minimum of 0 packets/day. Doses of placebo will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Serum K+ Levels From Baseline Time Frame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	Adjusted mean changes in serum K+ from Baseline.	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time Time Frame: From Day 1/Baseline to week 90	Cumulative incidence of the first event of hyperkalemia with a serum K+ value >5.5 mEq/l taking death as competing and calculated as CIF Estimates (95% CI) over time. Aalen-Johansen estimators of the cumulative incidence function with death as a competing event. CIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter	From Day 1/Baseline to week 90
CIF Estimates of the Reduction of the MRA Dose Below Target Dose Over Time Time Frame: From Day 1/Baseline to week 102	Cumulative incidence of the reduction of the MRA dose below target dose calculated as CIF Estimates (95% CI) over time. Note: The reduction below the MRA target dose must last for at least 14 days (orless if at the end of study) to confirm this endpoint. CIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter	From Day 1/Baseline to week 102
Investigator-reported Events of Hyperkalemia Time Frame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	Participant's follow-up is from the date of the first dose of randomized study medication up to the participant's end of study date or 24 Jun 2021, whichever comes first. Annualized event rate per 100 subject-years= The total number of events for all subjects in the treatment group divided by the total subject-years of follow-up in that treatment group multiplied by 100.	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
Hyperkalemia-related Hard Outcomes Endpoints Time Frame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	Analyzed using Win Ratio approach with the following hierarchical components: Time to CV death Total number of CV hospitalizations Total number of hyperkalemia toxicity events with serum K+ >6.5 mEq/l Total number of hyperkalemia events with serum K+ >6.0-6.5 mEq/l Total number of hyperkalemia events with serum K+ >5.0 mEq/l MHTE=More hyperkalemia toxicity events; MHE=More hyperkalemia events; CV=Cardiovascular	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
RAASi Use Score Time Frame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	RAASi use score (0 to 8 points) analyzed using the Win Ratio approach for each pair of participants with the following additive components: All-cause death Occurrence of a CV hospitalization HF medication use and dose for i) an ACEi/ARB/ARNi, ii) a MRA, and iii) a beta-blocker Each participant in each comparison can have 0-8 points and all participants are compared using this score at the respective appropriate follow-up time point. RAASi=renin-angiotensin-aldosterone system inhibitor; ACEi=angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARNi=angiotensin receptor/neprilysin inhibitor; MRA=mineralocorticoid receptor antagonist.	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

Collaborators and Investigators

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

Sponsor

Vifor Pharma, Inc.

Collaborators

Syneos Health, LLC

Investigators

Study Director: Peter Szecsödy, MD, Vifor Pharma

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

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 24, 2019

Primary Completion (Actual)

September 2, 2021

Study Completion (Actual)

September 2, 2021

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

PAT-CR-302
2018-005030-38 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data can be requested 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later.

Data will be indefinitely available for requesting

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and the study sponsor and researchers must sign a data sharing agreement.

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 (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

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

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

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

Keywords

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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