A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF)

May 1, 2026 updated by: Colorado Prevention Center

Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction Greater Than or Equal to 40% Hospitalized Due to an Episode of Acute Decompensated Heart Failure (REDEFINE-HF)

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment of hospitalized heart failure patients with mildly reduced or preserved ejection fraction.

Study Type

Interventional

Enrollment (Estimated)

5200

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

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1120
        • Recruiting
        • Buenos Aires City Investigative Site 20002
        • Contact:
      • Córdoba, Argentina, 5004
        • Recruiting
        • Córdoba Investigative Site 20005
        • Contact:
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, C1437JC
        • Recruiting
        • Buenos Aires Investigative Site 20009
        • Contact:
      • Buenos Aires, Buenos Aires, Argentina, 1180
        • Recruiting
        • Buenos Aires Investigative Site 20017
        • Contact:
      • La Plata, Buenos Aires, Argentina, 1904
        • Recruiting
        • La Plata, Buenos Aires Investigative Site 20023
        • Contact:
      • Lanus, Buenos Aires, Argentina, 1824
        • Recruiting
        • Lanús, Buenos Aires Investigative Site 20024
        • Contact:
    • Corrientes Province
      • Corrientes, Corrientes Province, Argentina, W3400AMZ
        • Recruiting
        • Corrientes Investigative Site 20001
        • Contact:
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5003
        • Recruiting
        • Córdoba, Córdoba Investigative Site 20014
        • Contact:
      • Córdoba, Córdoba Province, Argentina, 5000
        • Recruiting
        • Córdoba Investigative Site 20025
        • Contact:
      • Córdoba, Córdoba Province, Argentina, 5002
        • Recruiting
        • Córdoba Investigative Site 20012
        • Contact:
      • Córdoba, Córdoba Province, Argentina, 5003
        • Recruiting
        • Córdoba Investigative Site 20013
        • Contact:
      • Córdoba, Córdoba Province, Argentina, 5003
        • Recruiting
        • Córdoba Investigative Site 20016
        • Contact:
    • Salta Province
      • Salta, Salta Province, Argentina, 4400
        • Recruiting
        • Salta Investigative Site 20006
        • Contact:
    • San Juan Province
      • San Juan, San Juan Province, Argentina, 5400
        • Recruiting
        • San Juan, San Juan Investigative Site 20021
        • Contact:
      • San Juan, San Juan Province, Argentina, J5402
        • Recruiting
        • San Juan, San Juan Investigative Site 20020
        • Contact:
    • Santa Fe Province
      • Rafaela, Santa Fe Province, Argentina, 2300
        • Recruiting
        • Rafaela, Santa Fe Investigative Site 20026
        • Contact:
      • Rosario, Santa Fe Province, Argentina, 5000
        • Recruiting
        • Rosario, Santa Fe Investigative Site 20027
        • Contact:
      • Rosario, Santa Fe Province, Argentina, 2000
        • Recruiting
        • Rosario, Santa Fe Investigative Site 20003
        • Contact:
      • Rosario, Santa Fe Province, Argentina, 2000
        • Recruiting
        • Rosario, Santa Fe Investigative Site 20022
        • Contact:
      • Rosario, Santa Fe Province, Argentina, S2000CVD
        • Recruiting
        • Rosario, Santa Fe Investigative Site 20019
        • Contact:
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • Blacktown, NSW Investigative Site 50006
        • Contact:
    • Queensland
      • Milton, Queensland, Australia, 4064
        • Recruiting
        • Milton, Queensland Investigative Site 50001
        • Contact:
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Recruiting
        • Elizabeth Vale, South Australia Investigative Site 50008
        • Contact:
    • Victoria
      • Melbourne, Victoria, Australia, 3121
        • Recruiting
        • Melbourne, VIC Investigative Site 50005
        • Contact:
      • Mulgrave, Victoria, Australia, 3170
        • Recruiting
        • Mulgrave, Victoria Investigative Site 50004
        • Contact:
  • Brazil
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • São Paulo Investigative Site 21066
        • Contact:
    • Acre
      • Rio Branco, Acre, Brazil, 69915-030
        • Recruiting
        • Rio Branco, Acre Investigative Site 21063
        • Contact:
    • Alagoas
      • Arapiraca, Alagoas, Brazil, 57315-745
        • Recruiting
        • Arapiraca, Alagoas Investigative Site 21064
        • Contact:
    • Ceará I
      • Fortaleza, Ceará I, Brazil, 60864-190
        • Active, not recruiting
        • Fortaleza, Ceará Investigative Site 21055
    • Espírito Santo
      • Linhares, Espírito Santo, Brazil, 29900-010
        • Recruiting
        • Centro Linhares, Espirito Santo Investigative Site 21017
        • Contact:
      • Vila Velha, Espírito Santo, Brazil, 29118-060
        • Recruiting
        • Vila Velha, Espírito Santo Investigative Site 21059
        • Contact:
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40050-410
        • Recruiting
        • Salvador, Bahia Investigative Site 21032
        • Contact:
    • Federal District
      • Brasília, Federal District, Brazil, 70390-700
        • Recruiting
        • Brasília, Distrito Federal Investigative Site 21028
        • Contact:
    • Goiás
      • Aparecida de Goiânia, Goiás, Brazil, 74936-600
        • Recruiting
        • Aparecida de Goiânia, Goiás Investigative Site 21053
        • Contact:
      • Goiânia, Goiás, Brazil, 74453-200
        • Recruiting
        • Goiânia, Goiás Investigative Site 21003
        • Contact:
    • Minais Gerais
      • Belo Horizonte, Minais Gerais, Brazil, 30441-070
        • Recruiting
        • Belo Horizonte, Minais Gerais Investigative Site 21013
        • Contact:
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30220140
        • Recruiting
        • Belo Horizonte, Minas Gerais Investigative Site 21051
        • Contact:
      • Belo Horizonte, Minas Gerais, Brazil, 30180-080
        • Recruiting
        • Belo Horizonte, Minas Gerais Investigative Site 21020
        • Contact:
      • Poços de Caldas, Minas Gerais, Brazil, 37706-106
        • Recruiting
        • Poços de Caldas, Minas Gerais Investigative Site 21009
        • Contact:
    • Paraná
      • Curitiba, Paraná, Brazil, 80230-130
        • Recruiting
        • Curitiba, Paraná Investigative Site 21038
        • Contact:
      • Curitiba, Paraná, Brazil, 80060-900
        • Recruiting
        • Curitiba, Paraná Investigative Site 21056
        • Contact:
      • Curitiba, Paraná, Brazil, 80010-030
        • Recruiting
        • Curitiba, Parana Investigative Site 21029
        • Contact:
      • Londrina, Paraná, Brazil, 86.038-350
        • Recruiting
        • Londrina, Paraná Investigative Site 21047
        • Contact:
    • Pernambuco
      • Recife, Pernambuco, Brazil, 52010-075
        • Recruiting
        • Recife, Pernambuco Investigative Site 21061
        • Contact:
    • Piauí
      • Teresina, Piauí, Brazil, 64001-450
        • Recruiting
        • Teresina, Piaui Investigative Site 21050
        • Contact:
    • Recife
      • Recife, Recife, Brazil, 50720-110
        • Recruiting
        • Recife, Recife Investigative Site 21001
        • Contact:
    • Rio Grande Do Sull
      • Caxias do Sul, Rio Grande Do Sull, Brazil, 95070560
        • Recruiting
        • Caxias do Sul, Rio Grande do Sull Investigative Site 21008
        • Contact:
          • Marc Bonaca, MD
          • Phone Number: +1-303-860-9900
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 5902050
        • Recruiting
        • Natal, Rio Grande do Norte Investigative Site 21024
        • Contact:
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010 080
        • Recruiting
        • Passo Fundo, Rio Grande do Sul Investigative Site 21042
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brazil, 90630-165
        • Recruiting
        • Porto Alegre, Rio Grande do Sul Investigative Site 21025
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
        • Recruiting
        • Porto Alegre, RS Investigative Site 21060
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brazil, 90840-440
        • Recruiting
        • Porto Alegre, RS Investigative Site 21019
        • Contact:
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
        • Recruiting
        • Rio De Janeiro, Rio De Janeiro Investigative Site 21016
        • Contact:
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22280-003
        • Recruiting
        • Rio de Janeiro Investigative Site 21034
        • Contact:
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89204250
        • Recruiting
        • JOINVILLE, Santa Catarina Investigative Site 21007
        • Contact:
      • São José, Santa Catarina, Brazil, 88103-450
        • Recruiting
        • São José, Santa Catarina Investigative Site 21002
        • Contact:
    • Sergipe
      • Aracaju, Sergipe, Brazil, 409055-000
        • Recruiting
        • Aracaju, Sergipe Investigative Site 21058
        • Contact:
      • Aracaju, Sergipe, Brazil, 49055-530
        • Recruiting
        • Aracaju, Sergipe Investigative Site 21015
        • Contact:
    • São Paulo
      • Atibaia, São Paulo, Brazil, 12944-060
        • Recruiting
        • Atibaia, São Paulo Investigative Site 21057
        • Contact:
      • Bragança Paulista, São Paulo, Brazil, 12916542
        • Recruiting
        • Bragança Paulista, São Paulo Investigative Site 21004
        • Contact:
      • Itaquera, São Paulo, Brazil, 08270-120
        • Recruiting
        • Itaquera, São Paulo Investigative Site 21005
        • Contact:
      • Osasco, São Paulo, Brazil, 06013-070
        • Recruiting
        • Osasco, São Paulo Investigative Site 21010
        • Contact:
      • Presidente Prudente, São Paulo, Brazil, 19050-680
        • Recruiting
        • Presidente Prudente, São Paulo Investigative Site 21011
        • Contact:
      • Santo André, São Paulo, Brazil, 09090790
        • Not yet recruiting
        • Santo André, Sao Paulo Investigative Site 21043
        • Contact:
      • São Carlos, São Paulo, Brazil, 13566-448
        • Recruiting
        • São Carlos, São Paulo Investigative Site 21075
        • Contact:
      • São José dos Campos, São Paulo, Brazil, 12230-001
        • Recruiting
        • São José Dos Campos, Sao Paulo Investigative Site 21012
        • Contact:
      • São Paulo, São Paulo, Brazil, 01317002
        • Recruiting
        • São Paulo, São Paulo Investigative Site 21062
        • Contact:
      • São Paulo, São Paulo, Brazil, 04004-30
        • Recruiting
        • São Paulo, São Paulo Investigative Site 21048
        • Contact:
      • São Paulo, São Paulo, Brazil, 04550-000
        • Recruiting
        • São Paulo, São Paulo Investigative Site 21041
        • Contact:
      • São Paulo, São Paulo, Brazil, 04696040
        • Recruiting
        • São Paulo, São Paulo Investigative Site 21035
        • Contact:
      • São Paulo, São Paulo, Brazil, 05652900
        • Recruiting
        • São Paulo, São Paulo Investigative Site 21049
        • Contact:
      • São Paulo, São Paulo, Brazil, 01229-010
        • Recruiting
        • São Paulo Investigative Site 21074
        • Contact:
      • São Paulo, São Paulo, Brazil, 01308-070
        • Recruiting
        • São Paulo Investigative Site 21054
        • Contact:
      • São Paulo, São Paulo, Brazil, 01323-001
        • Recruiting
        • São Paulo Investigative Site 21037
        • Contact:
      • Votuporanga, São Paulo, Brazil, 15505-189
        • Recruiting
        • Votuporanga, São Paulo Investigative Site 21031
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • Calgary, AB Investigative Site 11009
        • Contact:
      • Edmonton, Alberta, Canada, T5H 3V9
        • Recruiting
        • Edmonton, AB Investigative Site 11018
        • Contact:
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • Edmonton, Alberta Investigative Site 11011
        • Contact:
    • British Columbia
      • Kamloops, British Columbia, Canada, V2C 2T1
        • Recruiting
        • Kamloops, BC Investigative Site 11021
        • Contact:
      • North Vancouver, British Columbia, Canada, V7M2H4
        • Not yet recruiting
        • North Vancouver, BC Investigative Site11020
        • Contact:
      • Surrey, British Columbia, Canada, V3V 0C6
        • Recruiting
        • Surrey, British Columbia Investigative Site 11012
        • Contact:
      • Vancouver, British Columbia, Canada, V6E 1M7
        • Recruiting
        • Vancouver, BC Investigative Site 11017
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Recruiting
        • Winnipeg, MB Investigative Site 11006
        • Contact:
    • Ontario
      • Cambridge, Ontario, Canada, N1R6V6
        • Recruiting
        • Cambridge, ON Investigative Site 11003
        • Contact:
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Recruiting
        • Sudbury, ON Investigative Site 11016
        • Contact:
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London, ON Investigative Site 11010
        • Contact:
      • North York, Ontario, Canada, M6B3H7
        • Recruiting
        • North York, Ontario Investigative Site 11007
        • Contact:
      • Toronto, Ontario, Canada, M4N3M5
        • Recruiting
        • Toronto, Ontario Investigative Site 11008
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • Toronto, ON Investigative Site 11019
        • Contact:
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto, ON Investigative Site 11001
        • Contact:
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Sherbrooke, QC Investigative Site 11005
        • Contact:
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • Recruiting
        • Regina, SK Investigative Site 11022
        • Contact:
  • Croatia
      • Krapinske Toplice, Croatia, 49217
        • Recruiting
        • Krapinske Toplice Investigative Site 30004
        • Contact:
      • Osijek, Croatia, 31000
        • Recruiting
        • Osijek Investigative Site 30008
        • Contact:
      • Varaždin, Croatia, 42000
        • Recruiting
        • Varazdin Investigative Site 30002
        • Contact:
      • Zagreb, Croatia, 10000
        • Recruiting
        • Zagreb Investigative Site 30001
        • Contact:
      • Zagreb, Croatia, 10000
        • Recruiting
        • Zagreb Investigative Site 30003
        • Contact:
      • Zagreb, Croatia, 10000
        • Recruiting
        • Zagreb Investigative Site 30006
        • Contact:
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 1000
        • Recruiting
        • Zagreb Investigative Site 30007
        • Contact:
    • Croatia
      • Zagreb, Croatia, Croatia, 10000
        • Recruiting
        • Zagreb, Grad Zagreb Investigative Site 30005
        • Contact:
    • Primorje-Gorski Kotar County
      • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
        • Recruiting
        • Rijeka Investigative Site 30009
        • Contact:
  • Czechia
      • Brno, Czechia, 612 00
        • Recruiting
        • Brno Investigative Site 31002
        • Contact:
      • Prague, Czechia, 140 21
        • Recruiting
        • Praha 4 Investigative Site 31003
        • Contact:
    • Czech Republic
      • Chlumec nad Cidlinou, Czech Republic, Czechia, 30100
        • Recruiting
        • Chlumec nad Cidlinou, Czech Republic Investigative Site 31005
        • Contact:
      • Pilsen, Czech Republic, Czechia, 30100
        • Recruiting
        • Plzeň, Czech Republic Investigative Site 31006
        • Contact:
    • Zidenice
      • Brno, Zidenice, Czechia, 615 00
        • Recruiting
        • Brno-Zidenice Investigative Site 31011
        • Contact:
  • Germany
      • Dresden, Germany, 01067
        • Recruiting
        • Dresden Investigative Site 32003
        • Contact:
      • Giessen, Germany, 35392
        • Recruiting
        • Giessen Investigative Site 32005
        • Contact:
      • Regensburg, Germany, 93053
        • Recruiting
        • Regensburg Investigative Site 32002
        • Contact:
    • Lübeck
      • Lübeck, Lübeck, Germany, 23538
        • Recruiting
        • Lübeck Investigative Site 32006
        • Contact:
    • State of Berlin
      • Berlin, State of Berlin, Germany, 13353
        • Recruiting
        • Berlin, Berlin Investigative Site 32001
        • Contact:
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Recruiting
        • Jena Investigative Site 32004
        • Contact:
  • Greece
    • Attica
      • Athens, Attica, Greece, 115 27
        • Recruiting
        • Athens, Attica Investigative Site 33001
        • Contact:
      • Athens, Attica, Greece, 115 27
        • Recruiting
        • Athens, Attica Investigative Site 33004
        • Contact:
      • Athens, Attica, Greece, 151 23
        • Recruiting
        • Athens, Attica Investigative Site 33005
        • Contact:
      • Chaïdári, Attica, Greece, 124 62
        • Recruiting
        • Chaidari, Attica Investigative Site 33006
        • Contact:
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece, 546 36
        • Recruiting
        • Thessaloniki, Central Macedonia Investigative Site 33002
        • Contact:
    • Greece
      • Athens, Greece, Greece, 14233
        • Recruiting
        • Athens, Investigative Site 33007
        • Contact:
      • Larissa, Greece, Greece, 41110
        • Recruiting
        • Larissa, Greece Investigative Site 33003
        • Contact:
  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Budapest Investigative Site 34001
        • Contact:
      • Budapest, Hungary, 1204
        • Recruiting
        • Budapest Investigative Site 34008
        • Contact:
      • Kaposvár, Hungary, 7400
        • Recruiting
        • Kaposvar Investigative Site 34005
        • Contact:
      • Orosháza, Hungary, 5900
        • Recruiting
        • Orosháza Investigative Site 34002
        • Contact:
      • Pécs, Hungary, 7624
        • Recruiting
        • Pecs Investigative Site 34006
        • Contact:
      • Szekszárd, Hungary, 7100
        • Recruiting
        • Szekszárd Investigative Site 34009
        • Contact:
    • Hungary
      • Nyíregyháza, Hungary, Hungary, 4400
        • Recruiting
        • Nyiregyhaza, Hungary Investigative Site 34004
        • Contact:
  • India
    • Bihar
      • Patna, Bihar, India, 800014
        • Recruiting
        • Patna, Bihar Investigative Site 51001
        • Contact:
    • Gujarat
      • Ahmedabad, Gujarat, India, 380005
        • Recruiting
        • Ahmedabad, Gujarat Investigative Site 51006
        • Contact:
    • Kerala
      • Kochi, Kerala, India, 682018
        • Recruiting
        • Kochi, Kerala Investigative Site 51007
        • Contact:
          • Marc Bonaca, MD
          • Phone Number: +1-303-860-9900
    • Maharashtra
      • Nagpur, Maharashtra, India, 440033
        • Recruiting
        • Nagpur, Maharashtra Investigative Site 51009
        • Contact:
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110017
        • Recruiting
        • New Delhi, Delhi Investigative Site 51004
        • Contact:
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Recruiting
        • New Delhi, Delhi Investigative Site 51011
        • Contact:
    • New Delhi
      • New Delhi, New Delhi, India, 110060
        • Recruiting
        • New Delhi, Delhi Investigative Site 51005
        • Contact:
    • Punjab
      • Mohali, Punjab, India, 160062
        • Recruiting
        • Mohali, Punjab Investigative Site 51012
        • Contact:
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 006
        • Recruiting
        • Chennai, Tamil Nadu Investigative site 51008
        • Contact:
  • Italy
    • BG
      • Bergamo, BG, Italy, 24127
        • Recruiting
        • Bergamo, BG Investigative Site 35001
        • Contact:
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Recruiting
        • Loc. Germaneto, Catanzaro CZ Investigative Site 35003
        • Contact:
    • GE
      • Genova, GE, Italy, 16132
        • Recruiting
        • Genova, GE Investigative Site 35005
        • Contact:
    • Varese
      • Varese, Varese, Italy, 21100
        • Recruiting
        • Varese, Varese Investigative Site 35004
        • Contact:
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • Recruiting
        • Kaunas Investigative Site 36004
        • Contact:
      • Klaipėda, Lithuania, LT-92231
        • Recruiting
        • Klaipeda Investigative Site 36002
        • Contact:
    • Lithuania
      • Alytus, Lithuania, Lithuania, LT-62114
        • Recruiting
        • Alytus, Lithuania Investigative Site 36005
        • Contact:
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • Kuala Lumpur Investigative Site 52001
        • Contact:
    • Johor
      • Johor Bahru, Johor, Malaysia, 80100
        • Recruiting
        • Johor Bahru Investigative Site 52002
        • Contact:
    • Kedah
      • Alor Star, Kedah, Malaysia, 05460
        • Recruiting
        • Alor Setar, Kedah Investigative Site 52006
        • Contact:
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50400
        • Recruiting
        • Kuala Lumpur, Wilayah Persekutuan Investigative Site 52007
        • Contact:
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Recruiting
        • Kuantan, Pahang Investigative Site 52004
        • Contact:
      • Kuantan, Pahang, Malaysia, 25200
        • Recruiting
        • Kuantan, Pahang Investigative Site 52009
        • Contact:
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10050
        • Recruiting
        • George Town, Penang Investigative Site 52003
        • Contact:
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Recruiting
        • Kajang, Selangor Investigative Site 52008
        • Contact:
    • Terengganu
      • Kuala, Terengganu, Malaysia, 20400
        • Recruiting
        • Kuala, Terengganu Investigative Site 52005
        • Contact:
  • Mexico
      • Mexico City, Mexico, C.P. 14080
        • Recruiting
        • Ciudad de México Investigative Site 23010
        • Contact:
    • Aguascalientes
      • Aguascalientes, Aguascalientes, Mexico, 20230
        • Recruiting
        • Aguascalientes Investigative Site 23001
        • Contact:
    • Flores
      • Culiacán, Flores, Mexico, 80230
        • Not yet recruiting
        • CULIACÁN, Flores Investigative Site 23002
        • Contact:
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Recruiting
        • Guadalajara, Jalisco Investigative Site 23003
        • Contact:
    • Mexico City
      • Cuauhtémoc, Mexico City, Mexico, 06720
        • Recruiting
        • Alcaldía Cuauhtémoc, Ciudad de México Investigative Site 23004
        • Contact:
      • Mexico City, Mexico City, Mexico, 10700
        • Recruiting
        • Ciudad de México Investigative Site 23011
        • Contact:
    • Michoacán
      • Morelia, Michoacán, Mexico, 58260
        • Not yet recruiting
        • Morelia, Michoacan Investigative Site 23007
        • Contact:
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Monterrey, Nuevo León Investigative Site 23005
        • Contact:
      • San Nicolás, Nuevo León, Mexico, 66465
        • Recruiting
        • San Nicolás de los Garza, Nuevo León Investigative Site 23008
        • Contact:
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80020
        • Recruiting
        • Culiacan, Sinaloa Investigative Site 23006
        • Contact:
    • Tlalpan
      • Mexico City, Tlalpan, Mexico, 14080
        • Recruiting
        • Ciudad de México Investigative Site 23009
        • Contact:
    • Veracruz
      • Xalapa, Veracruz, Mexico, 91193
        • Recruiting
        • Xalapa, Veracruz Investigative Site 23012
        • Contact:
  • Peru
      • Lima, Peru, 15036
        • Recruiting
        • Lima Investigative Site 24009
        • Contact:
      • Lima, Peru, 15036
        • Recruiting
        • Lima Investigative Site 24010
        • Contact:
      • Lima, Peru, 15072
        • Recruiting
        • Lima Investigative Site 24003
        • Contact:
      • Lima, Peru, 15076
        • Recruiting
        • Lima Investigative Site 24008
        • Contact:
      • Lima, Peru, 15082
        • Recruiting
        • Lima Investigative Site 24005
        • Contact:
      • Lima, Peru, 15102
        • Recruiting
        • Lima Investigative Site 24004
        • Contact:
    • Lima Province
      • Lima, Lima Province, Peru, 15046
        • Recruiting
        • Lima, Lima Investigative Site 24011
        • Contact:
  • Poland
      • Lodz, Poland, 92213
        • Recruiting
        • Łódź Investigative Site 37003
        • Contact:
      • Lodz, Poland, 90-549
        • Recruiting
        • Lodz Investigative Site 37001
        • Contact:
      • Lublin, Poland, 20-011
        • Recruiting
        • Lublin Investigative Site 37006
        • Contact:
      • Oświęcim, Poland, 32-600
        • Recruiting
        • Oświęcim Investigative Site 37002
        • Contact:
  • South Korea
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
        • Recruiting
        • Wonju-si, Gangwon-do Investigative Site 53002
        • Contact:
    • Guro-gu
      • Seoul, Guro-gu, South Korea, 08308
        • Recruiting
        • Guro-gu, Seoul Investigative Site 53007
        • Contact:
    • Incheon
      • Incheon, Incheon, South Korea, 22332
        • Recruiting
        • Jung-gu, Incheon Investigative Site 53009
        • Contact:
    • Jung-gu
      • Daejeon, Jung-gu, South Korea, 35015
        • Recruiting
        • Daejeon, Jung-gu Investigative Site 53004
        • Contact:
    • Seongbuk-gu
      • Seoul, Seongbuk-gu, South Korea, 02841
        • Recruiting
        • Seoul, Seongbuk-gu Investigative Site, 53006
        • Contact:
    • Seoul
      • Seoul, Seoul, South Korea, 03722
        • Recruiting
        • Seodaemun-gu, Seoul Investigative Site 53001
        • Contact:
  • Spain
      • Girona, Spain, 17007
        • Recruiting
        • Girona Investigative Site 38017
        • Contact:
      • Madrid, Spain, 28046
        • Recruiting
        • Madrid Investigative Site 38011
        • Contact:
      • Madrid, Spain, 28222
        • Recruiting
        • Madrid Investigative Site 38006
        • Contact:
      • Madrid, Spain, 28034
        • Recruiting
        • Madrid Investigative Site 38002
        • Contact:
      • Murcia, Spain, 30120
        • Recruiting
        • Murcia Investigative Site 38003
        • Contact:
      • Valencia, Spain, 46010
        • Recruiting
        • Valencia Investigative Site 38001
        • Contact:
      • Valencia, Spain, 46026
        • Recruiting
        • Valencia Investigative Site 38007
        • Contact:
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Badalona, Barcelona Investigative Site 38005
        • Contact:
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Recruiting
        • A Coruña, Galicia Investigative Site 38004
        • Contact:
      • Santiago de Compostela, Galicia, Spain, 15706
        • Recruiting
        • Santiago De Compostela, Galicia Investigative Site 38008
        • Contact:
    • Spain
      • Barcelona, Spain, Spain, 08907
        • Recruiting
        • Barcelona, Spain Investigative Site 38010
        • Contact:
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Recruiting
        • Manises, Valencia Investigative Site 38009
        • Contact:
  • Sri Lanka
    • Central Province
      • Kandy, Central Province, Sri Lanka, 2000
        • Recruiting
        • Kandy, Central Province Investigative Site 54001
        • Contact:
    • North Central Province
      • Polonnaruwa, North Central Province, Sri Lanka, 51000
        • Recruiting
        • Polonnaruwa, North Central Province Investigative Site 54012
        • Contact:
    • Northern Province
      • Jaffna, Northern Province, Sri Lanka, 40000
        • Recruiting
        • Jaffna, Northern Province Investigative Site 54010
        • Contact:
    • Western Province
      • Colombo, Western Province, Sri Lanka, 00200
        • Recruiting
        • Colombo 02, Western Province Investigative Site 54009
        • Contact:
      • Colombo, Western Province, Sri Lanka, 01000
        • Recruiting
        • Colombo 10, Western Province Investigative Site 54004
        • Contact:
      • Colombo, Western Province, Sri Lanka, 01000
        • Recruiting
        • Colombo 10, Western Province Investigative Site 54006
        • Contact:
      • Colombo, Western Province, Sri Lanka, 01000
        • Recruiting
        • Colombo 10, Western Province
        • Contact:
      • Colombo, Western Province, Sri Lanka, 10290
        • Recruiting
        • Boralesgamuwa, Western Province Investigative Site 54011
        • Contact:
      • Dehiwala, Western Province, Sri Lanka, 10350
        • Recruiting
        • Dehiwala, Western Province Investigative Site 54007
        • Contact:
      • Negombo, Western Province, Sri Lanka, 11500
        • Recruiting
        • Negombo, Western Province Investigative Site 54002
        • Contact:
      • Nugegoda, Western Province, Sri Lanka, 10250
        • Recruiting
        • Nugegoda, Western Province Investigative Site 54003
        • Contact:
      • Ragama, Western Province, Sri Lanka, 11010
        • Recruiting
        • Ragama, Western Province Investigative Site 54008
        • Contact:
  • Taiwan
    • Taiwan
      • Kaohsiung City, Taiwan, Taiwan, 807
        • Recruiting
        • Kaohsiung City, Taiwan, Investigative Site 55002
        • Contact:
      • Taipei, Taiwan, Taiwan, 106
        • Recruiting
        • Taipei, Taiwan Investigative Site 55008
        • Contact:
      • Taipei, Taiwan, Taiwan, 112401
        • Recruiting
        • Taipei City, Taiwan Investigative Site 55009
        • Contact:
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • Cardiff, Investigative Site 39015
        • Contact:
      • Glasgow, United Kingdom, G4 0SF
        • Recruiting
        • Glasgow Investigative Site 39001
        • Contact:
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • London, Investigative Site 39016
        • Contact:
      • London, United Kingdom, SW17 0QT
        • Recruiting
        • London, Investigative Site 39002
        • Contact:
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Manchester Investigative Site 39003
        • Contact:
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Plymouth, Investigative Site 39014
        • Contact:
      • Portadown, United Kingdom, BT63 5QQ
        • Recruiting
        • Portadown, Investigative Site 39005
        • Contact:
      • Swindon, United Kingdom, SN3 6BB
        • Recruiting
        • Swindon Investigative Site 39004
        • Contact:
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 1ES
        • Recruiting
        • Brighton, East Sussex Investigative Site 39021
        • Contact:
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton, Hampshire Investigative Site 39006
        • Contact:
    • Kent
      • Ashford, Kent, United Kingdom, TN02 0LZ
        • Recruiting
        • Ashford, Kent Investigative Site 39020
        • Contact:
    • Liverpool
      • Liverpool, Liverpool, United Kingdom, L9 7AL
        • Recruiting
        • Liverpool, Liverpool Investigative Site 39024
        • Contact:
    • North West England
      • Chester, North West England, United Kingdom, CH2 1UL
        • Recruiting
        • Chester, North West England Investigative Site 39022
        • Contact:
    • Northumberland
      • Ashington, Northumberland, United Kingdom, NE63 9JJ
        • Recruiting
        • Ashington, Northumberland Investigative Site 39017
        • Contact:
    • West Midlands
      • Dudley, West Midlands, United Kingdom, DY1 2HQ
        • Recruiting
        • Dudley, West Midlands Investigative Site 39018
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Birmingham, AL Investigative Site 10012
        • Contact:
      • Fairhope, Alabama, United States, 36532
        • Recruiting
        • Fairhope, AL Investigative Site 10004
        • Contact:
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Huntsville, AL Investigative Site 10026
        • Contact:
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Recruiting
        • Glendale, AZ Investigative Site 10096
        • Contact:
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Scottsdale, AZ Investigative Site 10003
        • Contact:
    • California
      • Chula Vista, California, United States, 91911
        • Recruiting
        • Chula Vista, CA Investigative Site 10111
        • Contact:
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Huntington Beach, CA Investigative Site 10031
        • Contact:
      • Los Angeles, California, United States, 90073
        • Recruiting
        • Los Angeles, CA Investigative Site 10089
        • Contact:
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sacramento, CA Investigative Site 10024
        • Contact:
      • San Francisco, California, United States, 94118
        • Recruiting
        • San Francisco, CA Investigative Site 10023
        • Contact:
      • Tarzana, California, United States, 91356
        • Recruiting
        • Tarzana, CA Investigative Site 10409
        • Contact:
      • Van Nuys, California, United States, 91405
        • Recruiting
        • Van Nuys, CA Investigative Site 10109
        • Contact:
      • West Hills, California, United States, 91307
        • Recruiting
        • West Hills, CA Investigative Site 10013
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Aurora, CO Investigative Site 10001
        • Contact:
      • Denver, Colorado, United States, 80204
        • Recruiting
        • Denver, CO Investigative Site 10005
        • Contact:
    • Florida
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Bradenton, FL Investigative Site 10125
        • Contact:
      • Brooksville, Florida, United States, 34613
        • Recruiting
        • Brooksville, FL Investigative Site 10077
        • Contact:
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Fort Lauderdale, FL Investigative Site 10114
        • Contact:
      • Fort Myers, Florida, United States, 33919
        • Recruiting
        • Fort Myers, FL Investigative Site 10076
        • Contact:
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Hialeah, FL Investigative Site 10104
        • Contact:
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • Jacksonville, FL Investigative Site 10028
        • Contact:
      • Miami, Florida, United States, 33135
        • Recruiting
        • Miami, FL Investigative Site 10105
        • Contact:
      • Miami, Florida, United States, 33173
        • Recruiting
        • Miami, FL Investigative Site 10040
        • Contact:
      • Miramar, Florida, United States, 33027
        • Not yet recruiting
        • Miramar, FL Investigative Site 10113
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Atlanta, GA Investigative Site 10022
        • Contact:
      • Duluth, Georgia, United States, 30096
        • Recruiting
        • Duluth, GA Investigative Site 10083
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Boise, Idaho Investigative Site 10073
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Chicago, IL Investigative Site 10062
        • Contact:
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • Glenview, IL Investigative Site 10021
        • Contact:
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Naperville, IL Investigative Site 10025
        • Contact:
      • Peoria, Illinois, United States, 61603
        • Recruiting
        • Peoria, IL Investigative Site 10019
        • Contact:
      • Peoria, Illinois, United States, 61614
        • Recruiting
        • Peoria, IL Investigative Site 10010
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Indianapolis, IN Investigative Site 10074
        • Contact:
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Indianapolis, IN Investigative Site 10008
        • Contact:
      • Merrillville, Indiana, United States, 46410
        • Recruiting
        • Merrillville, IN Investigative Site 10064
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • Recruiting
        • Kansas City, KS Investigative Site 10060
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • Lexington, KY Investigative Site 10118
        • Contact:
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Lexington, KY Investigative Site 10080
        • Contact:
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Louisville, KY Investigative Site 10006
        • Contact:
      • Louisville, Kentucky, United States, 40205
        • Not yet recruiting
        • Louisville, KY Investigative Site 10086
        • Contact:
      • Paducah, Kentucky, United States, 42003
        • Recruiting
        • Paducah, KY Investigative Site 10079
        • Contact:
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Baton Rouge, LA Investigative Site 10030
        • Contact:
      • Hammond, Louisiana, United States, 70403
        • Recruiting
        • Hammond, LA Investigative Site 10106
        • Contact:
      • West Monroe, Louisiana, United States, 71291
        • Recruiting
        • West Monroe, LA Investigative Site 10090
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Baltimore, MD Investigative Site 10101
        • Contact:
      • Bowie, Maryland, United States, 20715
        • Recruiting
        • Bowie, MD Investigative Site 10020
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Boston, MA Investigative Stie 10087
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407-1139
        • Recruiting
        • Minneapolis, MN Investigative Site 10091
        • Contact:
      • Minneapolis, Minnesota, United States, 55417
        • Recruiting
        • Minneapolis, MN Investigative Site 10035
        • Contact:
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Not yet recruiting
        • Tupelo, MS Investigative Site 10100
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Kansas City, MO Investigative Site 10002
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Recruiting
        • Omaha, NE Investigative Site 10018
        • Contact:
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Camden, NJ Investigative Site 10033
        • Contact:
    • New York
      • Roslyn, New York, United States, 11576
        • Recruiting
        • Roslyn, NY Investigative Site 10058
        • Contact:
      • Stony Brook, New York, United States, 11794-8171
        • Recruiting
        • Stony Brook, NY Investigative Site 10017
        • Contact:
    • Ohio
      • Akron, Ohio, United States, 44304
        • Recruiting
        • Akron, OH Investigative Site 10081
        • Contact:
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Centerville, OH Investigative Site 10119
        • Contact:
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • Cincinnati, OH Investigative Site 10088
        • Contact:
    • Oklahoma
      • Bartlesville, Oklahoma, United States, 74006
        • Recruiting
        • Bartlesville, OK Investigative Site 10095
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Philadelphia, PA Investigative Site 10068
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Pittsburg, PA Investigative Site 1044
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Recruiting
        • Providence, RI Investigative Site 10050
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Charleston, SC Investigative Site 10056
        • Contact:
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Germantown, TN Investigative Site 10063
        • Contact:
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • Memphis, TN Investigative Site 10059
        • Contact:
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Nashville, TN Investigative Site 10071
        • Contact:
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • Amarillo, TX Investigative Site 10045
        • Contact:
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin, TX Investigative Site 10015
        • Contact:
      • Dallas, Texas, United States, 75216
        • Recruiting
        • Dallas, TX Investigative Site 10042
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston, TX Investigative Site 10085
        • Contact:
      • Plano, Texas, United States, 75093
        • Recruiting
        • Plano, TX Investigative Site 10014
        • Contact:
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • Burlington, VT Investigative Site 10053
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Norfolk, VA Investigative Site 10009
        • Contact:
      • Richmond, Virginia, United States, 23225
        • Recruiting
        • Richmond, VA Investigative Site 10069
        • Contact:
      • Richmond, Virginia, United States, 23249
        • Recruiting
        • Richmond, VA Investigative Site 10067
        • Contact:
          • Marc Bonaca, MD
          • Phone Number: +1-303-860-9900
      • Salem, Virginia, United States, 24153
        • Recruiting
        • Salem, VA Investigative Site 10048
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Milwaukee, WI Investigative Site 10061
        • Contact:

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

No

Description

Inclusion Criteria:

  • Provide written informed consent
  • Age ≥18 years or legal age of majority if >18 years in the participant's country of residence
  • Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure
  • Heart failure signs and symptoms at the time of hospital admission
  • Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
  • Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF

Exclusion Criteria:

  • Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA)
  • Documented prior history of severe hyperkalemia in the setting of MRA use
  • Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or potassium >5.0 mmol/L at screening
  • Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
  • Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
  • Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction
  • Probable alternative cause of participant's heart failure symptoms
  • Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
  • Known hypersensitivity to the IP (active substance or excipients)

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matching oral placebo
Experimental: Finerenone
Drug: Finerenone
Oral finerenone
Other Names:
  • Kerendia
  • Firialta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of serious adverse events.
Time Frame: Ongoing, up to ~30 months
Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Ongoing, up to ~30 months
Number of adverse events leading to discontinuation of study drug.
Time Frame: Ongoing, up to ~30 months
Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.
Ongoing, up to ~30 months
Composite of total HF events and cardiovascular (CV) death.
Time Frame: Ongoing, up to ~30 months
Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
Ongoing, up to ~30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first occurrence of the composite of CV death or HF event.
Time Frame: Ongoing, up to ~30 months
Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.
Ongoing, up to ~30 months
Total HF events.
Time Frame: Ongoing, up to ~30 months
Total HF events with finerenone compared to placebo.
Ongoing, up to ~30 months
Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.
Time Frame: 6 Months
6 Months
Time to CV death.
Time Frame: Ongoing, up to ~30 months
Time to CV death with finerenone compared to placebo.
Ongoing, up to ~30 months
Time to death from any cause.
Time Frame: Ongoing, up to ~30 months
Time to death from any cause with finerenone compared to placebo.
Ongoing, up to ~30 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total hospitalizations for any cause.
Time Frame: Ongoing, up to ~30 months
Total hospitalizations for any cause with finerenone compared to placebo.
Ongoing, up to ~30 months
Total number of days alive and out of the hospital.
Time Frame: Ongoing, up to ~30 months
Days alive and out of hospital with finerenone compared to placebo.
Ongoing, up to ~30 months
Number of patients with sustained decrease in eGFR ≥40% relative to baseline.
Time Frame: Ongoing, up to ~30 months
Sustained decrease in eGFR ≥40% relative to baseline with finerenone compared to placebo.
Ongoing, up to ~30 months
Number of patients with sustained eGFR <15 ml/min/1.73 m^2.
Time Frame: Ongoing, up to ~30 months
Sustained eGFR <15 ml/min/1.73 m^2 with finerenone compared to placebo.
Ongoing, up to ~30 months
Number of patients requiring initiation of dialysis or renal transplant.
Time Frame: Ongoing, up to ~30 months
Initiation of dialysis or renal transplant with finerenone compared to placebo.
Ongoing, up to ~30 months

Collaborators and Investigators

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

Sponsor

Colorado Prevention Center

Collaborators

Bayer
St. Luke's Hospital, Kansas City, Missouri

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)

January 17, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301CPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plan to share individual patient data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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