A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)

July 8, 2026 updated by: Colorado Prevention Center

A Randomized, Double-blind, Placebo-controlled Pragmatic Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure and Reduced Ejection Fraction Who Are Intolerant of or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

2600

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, 1425
        • Recruiting
        • Buenos Aires Investigative Site FIN-20031
        • Contact:
      • Córdoba, Argentina, 5000
        • Recruiting
        • Córdoba Investigative Site FIN-20025
        • Contact:
      • Córdoba, Argentina, 5000
        • Recruiting
        • Córdoba Investigative Site FIN-20030
        • Contact:
      • San Juan, Argentina, J5402DIL
        • Recruiting
        • San Juan, San Juan Investigative Site FIN-20020
        • Contact:
      • San Juan, Argentina, J5402DIL
        • Recruiting
        • San Juan, San Juan Investigative Site FIN-20021
        • Contact:
    • Buenos Aires
      • Lanus, Buenos Aires, Argentina, 1824
        • Recruiting
        • Lanus, Buenos Aires Investigative Site FIN-20024
        • Contact:
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2300
        • Recruiting
        • Rosario, Santa Fe Investigative Site FIN-20022
        • Contact:
  • Brazil
      • Rio de Janeiro, Brazil, 22280-003
        • Recruiting
        • Rio de Janeiro Investigative Site FIN-21034
        • Contact:
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • São Paulo Investigative Site FIN-21066
        • Contact:
    • Acre
      • Rio Branco, Acre, Brazil, 69915-030
        • Recruiting
        • FIN-21063, Rio Branco, Acre
        • Contact:
    • Alagoas
      • Maceió, Alagoas, Brazil, 57051-160
        • Recruiting
        • FIN-21078, Maceió, Alagoas
        • Contact:
    • Bahia - BA
      • Salvador, Bahia - BA, Brazil, 40290-000
        • Recruiting
        • FIN-21072 Salvador, Bahia - BA
        • Contact:
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430275
        • Recruiting
        • Fortaleza, Ceará Investigative Site'FIN-21076
        • Contact:
      • Fortaleza, Ceará, Brazil, 60864-190
        • Recruiting
        • Fortaleza, Ceará Investigative Site FIN-21055
        • Contact:
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40050-410
        • Recruiting
        • FIN-21032, Salvador, Bahia
        • Contact:
    • Federal District
      • Brasília, Federal District, Brazil, 70390-700
        • Recruiting
        • FIN-21028, Brasilia, Distrito Federal
        • Contact:
    • Goiás
      • Aparecida de Goiânia, Goiás, Brazil, 74936-600
        • Recruiting
        • FIN-21053, Aparecida de Goiânia, Goiás
        • Contact:
      • Goiânia, Goiás, Brazil, 74453-200
        • Recruiting
        • FIN-21003 Goiania, Goias Investigational Site
        • Contact:
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-934
        • Recruiting
        • Belo Horizonte, Minas Gerais
        • Contact:
      • Belo Horizonte, Minas Gerais, Brazil, 30150-320
        • Recruiting
        • FIN-21071, Belo Horizonte, Minas Gerais
        • Contact:
      • Belo Horizonte, Minas Gerais, Brazil, 30220-140
        • Recruiting
        • FIN-21051, Belo Horizonte, Minas Gerais
        • Contact:
      • Belo Horizonte, Minas Gerais, Brazil, 30220-330
        • Recruiting
        • Belo Horizonte, Minas Gerais Investigative Site FIN-21079
        • Contact:
      • Belo Horizonte, Minas Gerais, Brazil, 30441-070
        • Recruiting
        • FIN-21013, Belo Horizonte, Minas Gerais
        • Contact:
    • Paraná
      • Curitiba, Paraná, Brazil, 80060-900
        • Recruiting
        • FIN-21056, Curitiba, Paraná
        • Contact:
      • Londrina, Paraná, Brazil, 86.038-350
        • Recruiting
        • FIN-21047, Londrina, Paraná
        • Contact:
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50100-040
        • Recruiting
        • FIN-21021, Recife, Pernambuco
        • Contact:
      • Recife, Pernambuco, Brazil, 51.110-160
        • Recruiting
        • Recife, Pernambuco Investigative Site FIN-21086
        • Contact:
      • Recife, Pernambuco, Brazil, 52010-075
        • Recruiting
        • FIN-21061, Recife, Pernambuco
        • Contact:
    • Piauí
      • Teresina, Piauí, Brazil, 64001-450
        • Recruiting
        • Teresina, Piaui Investigative Site FIN-21050
        • Contact:
    • Recife
      • Recife, Recife, Brazil, 50720-110
        • Recruiting
        • FIN-21001, Recife, Recife
        • Contact:
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 5902050
        • Recruiting
        • FIN-21024, Natal, Rio Grande do Norte
        • Contact:
    • Rio Grande do Sul
      • Caxias do Sul, Rio Grande do Sul, Brazil, 95070-560
        • Recruiting
        • FIN-21008, Caxias do Sul, Rio Grande do Sul
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brazil, 90840-440
        • Recruiting
        • FIN-21019, Porto Alegre, Rio Grande do Sul
        • Contact:
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
        • Recruiting
        • FIN-21016, Rio De Janeiro, Rio De Janeiro
        • Contact:
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22240-006
        • Recruiting
        • FIN-21014, Rio de Janeiro, Rio de Janeiro
        • Contact:
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89200-000
        • Recruiting
        • FIN-21007, Joinville, Santa Catarina
        • Contact:
    • Sergipe
      • Aracaju, Sergipe, Brazil, 49055-210
        • Recruiting
        • FIN-21058, Aracaju, Sergipe
        • Contact:
    • São Paulo
      • Bragança Paulista, São Paulo, Brazil, 12916542
        • Recruiting
        • FIN-21004 Braganca Paulista, Sao Paulo
        • Contact:
      • Campinas, São Paulo, Brazil, 13083-190
        • Recruiting
        • Campinas, São Paulo Investigative Site' FIN-21083
        • Contact:
      • Guarulhos, São Paulo, Brazil, 07197-000
        • Recruiting
        • FIN-21068, Guarulhos, São Paulo
        • Contact:
      • Itaquera, São Paulo, Brazil, 08270-120
        • Recruiting
        • FIN-21005, Itaquera, São Paulo
        • Contact:
      • Osasco, São Paulo, Brazil, 06013-070
        • Recruiting
        • FIN-21010, Osasco, São Paulo
        • Contact:
      • Presidente Prudente, São Paulo, Brazil, 19050-680
        • Recruiting
        • FIN-21011, Presidente Prudente, São Paulo
        • Contact:
      • Santo André, São Paulo, Brazil, 09090790
        • Recruiting
        • FIN-21043, Santo André, São Paulo
        • Contact:
      • São Carlos, São Paulo, Brazil, 13566-448
        • Recruiting
        • São Carlos, São Paulo Investigative Site FIN-21075
        • Contact:
      • São José dos Campos, São Paulo, Brazil, 12243000
        • Recruiting
        • São José dos Campos, São Paulo Investigative Site'FIN-21081
        • Contact:
      • São Paulo, São Paulo, Brazil, 01229-010
        • Recruiting
        • FIN-21074, São Paulo, São Paulo
        • Contact:
      • São Paulo, São Paulo, Brazil, 01323-001
        • Recruiting
        • FIN-21037, São Paulo, São Paulo
        • Contact:
      • São Paulo, São Paulo, Brazil, 04004-30
        • Recruiting
        • FIN-21048, São Paulo, São Paulo
        • Contact:
      • São Paulo, São Paulo, Brazil, 05652-900
        • Recruiting
        • FIN-21049 Sao Paulo, Sao Paulo
        • Contact:
      • Votuporanga, São Paulo, Brazil, 15505-189
        • Recruiting
        • FIN-21031, Votuporanga, São Paulo
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Recruiting
        • Calgary, AB Investigative Site FIN-11009
        • Contact:
      • Edmonton, Alberta, Canada, T5H 4B9
        • Recruiting
        • FIN-11028, Edmonton, AB
        • Contact:
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • FIN-11011, Edmonton, AB
        • Contact:
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7M 2H4
        • Recruiting
        • FIN-11020, North Vancouver, BC
        • Contact:
      • Surrey, British Columbia, Canada, V3V OC6
        • Recruiting
        • FIN-11012 Surrey, BC Investigational Site
        • Contact:
      • Victoria, British Columbia, Canada, V8R 1B2
        • Recruiting
        • FIN-11025, Victoria, BC
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Recruiting
        • FIN-11006, Winnipeg, MB
        • Contact:
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Recruiting
        • FIN-11016, Sudbury, ON
        • Contact:
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • FIN-11024, Kingston, ON
        • Contact:
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • FIN-11010, London, ON
        • Contact:
      • North York, Ontario, Canada, M6B 3H7
        • Recruiting
        • FIN-11007, North York, ON
        • Contact:
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • FIN-11008, Toronto, ON
        • Contact:
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • FIN-11019, Toronto, ON
        • Contact:
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • FIN-11005, Sherbrooke, QC
        • Contact:
  • Croatia
      • Krapinske Toplice, Croatia, 49217
        • Recruiting
        • FIN-30004, Krapinske Toplice
        • Contact:
      • Osijek, Croatia, 31000
        • Recruiting
        • Osijek Investigative Site FIN-30008
        • Contact:
      • Čepin, Croatia, 31431
        • Recruiting
        • Cepin Investigative Site FIN-30010
        • Contact:
    • Croatia
      • Zagreb, Croatia, Croatia, 10000
        • Recruiting
        • FIN-30001, Zagreb, Croatia
        • Contact:
      • Zagreb, Croatia, Croatia, 10000
        • Recruiting
        • FIN-30003, Zagreb, Croatia
        • Contact:
      • Zagreb, Croatia, Croatia, 10000
        • Recruiting
        • FIN-30007, Zagreb, Croatia
        • Contact:
  • Czechia
    • Czech Republic
      • Brno, Czech Republic, Czechia, 612 00
        • Recruiting
        • FIN-31002, Brno, Czech Republic
        • Contact:
  • Greece
    • Attica
      • Athens, Attica, Greece, 115 27
        • Recruiting
        • Athens, Attica Investigative Site FIN-33004
        • Contact:
      • Athens, Attica, Greece, 155 62
        • Recruiting
        • Athens, Attica Investigative Site FIN-33009
        • Contact:
          • Marc Bonaca, MD
          • Phone Number: +1-303-860-9900
      • Chaïdári, Attica, Greece, 124 62
        • Recruiting
        • Chaidari, Attica Investigative Site FIN-33006
        • Contact:
      • Kallithea, Attica, Greece, 176 74
        • Recruiting
        • Kallithea, Attica Investigative Site FIN-33010
        • Contact:
      • Nea Ionia, Attica, Greece, 142 33
        • Recruiting
        • Nea Ionia, Attica Investigative Site FIN-33007
        • Contact:
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece, 546 36
        • Recruiting
        • Thessaloniki, Central Macedonia Investigative Site FIN-33002
        • Contact:
          • Marc Bonaca, MD
          • Phone Number: +1-303-860-9900
    • Evros
      • Alexandroupoli, Evros, Greece, 68100
        • Recruiting
        • Alexandroupolis, Evros Investigative Site FIN-33012
        • Contact:
  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Budapest Investigative Site FIN-34001
        • Contact:
      • Gyöngyös, Hungary, 3200
        • Recruiting
        • Gyöngyös Investigative Site FIN-34011
        • Contact:
      • Pécs, Hungary, 7624
        • Recruiting
        • Pecs Investigative Site FIN-34006
        • Contact:
    • Hungary
      • Nyíregyháza, Hungary, Hungary, 4400
        • Recruiting
        • FIN-34004, Nyiregyhaza, Hungary
        • Contact:
  • Italy
    • BS
      • Brescia, BS, Italy, 25123
        • Recruiting
        • Brescia, BS Investigative Site FIN-35006
        • Contact:
    • CZ
      • Germaneto, CZ, Italy, 88100
        • Recruiting
        • FIN-35003, Loc. Germaneto - Catanzaro, CZ
        • Contact:
  • Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • FIN-57002, Sapporo, Hokkaido
        • Contact:
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Recruiting
        • FIN-57009, Isehara, Kanagawa
        • Contact:
      • Sagamihara, Kanagawa, Japan, 252-5188
        • Recruiting
        • FIN-57006, Sagamiharam, Kanagawa
        • Contact:
    • Kyoto
      • Kyoto, Kyoto, Japan, 606-8507
        • Recruiting
        • FIN-57001, Kyoto, Kyoto
        • Contact:
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • FIN-57003, Sendai, Miyagi
        • Contact:
    • Osaka
      • Osaka, Osaka, Japan, 530-0005
        • Recruiting
        • FIN-57004, Osaka, Osaka
        • Contact:
      • Suita, Osaka, Japan, 564-8565
        • Recruiting
        • FIN-57007, Suita, Osaka
        • Contact:
    • Tokyo
      • Ōta-ku, Tokyo, Japan, 143-8540
        • Recruiting
        • FIN-57009, Ota-ku, Tokyo
        • Contact:
    • Yamaguchi
      • Iwakuni, Yamaguchi, Japan, 740-8510
        • Recruiting
        • FIN-57005, Iwakuni, Yamaguchi
        • Contact:
  • Poland
      • Krakow, Poland, 30-702
        • Recruiting
        • Kraków Investigative Site FIN-37007
        • Contact:
      • Lodz, Poland, 92-213
        • Recruiting
        • Łódź Investigative Site FIN-37003
        • Contact:
      • Tychy, Poland, 43-100
        • Recruiting
        • Tychy, Investigative Site FIN-37009
        • Contact:
          • Marc Bonaca, MD
          • Phone Number: +1-303-860-9900
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-011
        • Recruiting
        • FIN-37006, Lublin, Lublin
        • Contact:
    • Oswiecim
      • Oświęcim, Oswiecim, Poland, 32-600
        • Recruiting
        • FIN-37002, Oswiecim, Oswiecim
        • Contact:
  • Spain
      • Barcelona, Spain, 08907
        • Recruiting
        • Barcelona Investigative Site FIN-38010
        • Contact:
    • Catalonia
      • Girona, Catalonia, Spain, 17007
        • Recruiting
        • Gerona, Cataluña Investigative Site FIN-38017
        • Contact:
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Recruiting
        • A Coruña, Galicia Investigative Site FIN-38004
        • Contact:
      • Santiago de Compostela, Galicia, Spain, 15706
        • Recruiting
        • FIN-38008, Santiago de Compostela, Galicia
        • Contact:
    • Madrid
      • Madrid, Madrid, Spain, 28034
        • Recruiting
        • FIN-38002, Madrid, Madrid
        • Contact:
      • Madrid, Madrid, Spain, 28046
        • Recruiting
        • FIN-38011, Madrid, Madrid
        • Contact:
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • FIN-38006, Majadahonda, Madrid
        • Contact:
    • Málaga
      • Málaga, Málaga, Spain, 29010
        • Recruiting
        • FIN-38012, Málaga, Málaga
        • Contact:
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Recruiting
        • FIN-38009, Manises, Valencia
        • Contact:
      • Valencia, Valencia, Spain, 46026
        • Recruiting
        • FIN-38001, Valencia, Valencia
        • Contact:
      • Valencia, Valencia, Spain, 46026
        • Recruiting
        • FIN-38007, Valencia, Valencia
        • Contact:
  • Sri Lanka
    • Central Province
      • Kandy, Central Province, Sri Lanka, 2000
        • Recruiting
        • Kandy, Central Province Investigative Site FIN-54001
        • Contact:
    • Northern Province
      • Jaffna, Northern Province, Sri Lanka, 40000
        • Recruiting
        • Jaffna, Northern Province Investigative Site FIN-54014
        • Contact:
    • Northwestern Province
      • Kurunegala, Northwestern Province, Sri Lanka, 60000
        • Recruiting
        • Kurunegala, Northwestern Province Investigative Site FIN-54013
        • Contact:
    • Western Province
      • Colombo, Western Province, Sri Lanka, 01000
        • Recruiting
        • Colombo, Western Province Investigative Site FIN-54004
        • Contact:
      • Colombo, Western Province, Sri Lanka, 01000
        • Recruiting
        • Colombo, Western Province Investigative Site FIN-54006
        • Contact:
      • Colombo, Western Province, Sri Lanka, 10350
        • Recruiting
        • Colombo, Western Province Investigative Site FIN-54007
        • Contact:
      • Negombo, Western Province, Sri Lanka, 11500
        • Recruiting
        • Negombo, Western Province Investigative Site FIN-54002
        • Contact:
      • Ragama, Western Province, Sri Lanka, 11010
        • Recruiting
        • Ragama, Western Province Investigative Site FIN-54008
        • Contact:
  • United Kingdom
      • Glasgow, United Kingdom, G4 0SF
        • Recruiting
        • FIN-39001, Glasgow, UK
        • Contact:
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • FIN-39006, Southampton, UK
        • Contact:
    • UK
      • Bristol, UK, United Kingdom, BS10 5NB
        • Recruiting
        • FIN-39007, Bristol, UK
        • Contact:
      • London, UK, United Kingdom, SW17 0QT
        • Recruiting
        • London, UK
        • Contact:
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Recruiting
        • FIN-10004 Fairhope, AL Investigational Site
        • Contact:
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Phoenix, AZ Investigative Site FIN-10115
        • Contact:
      • Yuma, Arizona, United States, 85365
        • Recruiting
        • FIN-10401, Yuma, AZ
        • Contact:
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Chula Vista, CA Investigative Site FIN-10419
        • Contact:
      • Chula Vista, California, United States, 91911
        • Recruiting
        • Chula Vista, CA Investigative Site FIN-10111
        • Contact:
      • Northridge, California, United States, 91324
        • Recruiting
        • FIN-10407, Northridge, CA
        • Contact:
      • Orange, California, United States, 92866
        • Recruiting
        • FIN-10412, Orange, CA
        • Contact:
      • Pomona, California, United States, 91767
        • Recruiting
        • FIN-10070, Pamona, CA
        • Contact:
      • Sacramento, California, United States, 95816
        • Recruiting
        • FIN-10024, Sacramento, CA
        • Contact:
      • San Diego, California, United States, 92243
        • Recruiting
        • FIN-10075 San Diego, CA Investigational Site
        • Contact:
      • San Diego, California, United States, 91127
        • Recruiting
        • FIN-10406, San Diego, CA
        • Contact:
      • San Diego, California, United States, 92111
        • Recruiting
        • San Diego, CA Investigative Site FIN-10420
        • Contact:
      • San Francisco, California, United States, 94118
        • Recruiting
        • San Francisco, CA Investigative Site FIN-10023
        • Contact:
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • FIN-10423, Sherman Oaks, CA
        • Contact:
      • Tarzana, California, United States, 91356
        • Recruiting
        • FON-10409, Tarzana, CA
        • Contact:
      • Van Nuys, California, United States, 91405
        • Recruiting
        • FIN-10109, Van Nuys, CA
        • Contact:
      • West Covina, California, United States, 91790
        • Recruiting
        • FIN-10408, West Covina, CA
        • Contact:
      • West Hills, California, United States, 91307
        • Recruiting
        • FIN-10013, West Hills, CA
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • FIN-10110, Aurora, CO
        • Contact:
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • FIN-10001, Aurora, CO
        • Contact:
    • Florida
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Bradenton, FL Investigative Site FIN-10125
        • Contact:
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • FIN-10104, Hialeah, FL
        • Contact:
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • FIN-10028, Jacksonville, FL
        • Contact:
      • Miami, Florida, United States, 33135
        • Recruiting
        • FIN-10105, Miami, FL
        • Contact:
      • Miramar, Florida, United States, 33027
        • Recruiting
        • FIN-10113, Miramar, FL
        • Contact:
    • Illinois
      • Peoria, Illinois, United States, 61603
        • Recruiting
        • FIN-10019, Peoria, IL
        • Contact:
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Recruiting
        • FIN-10064, Merrillville, IN
        • Contact:
    • Kentucky
      • Cynthiana, Kentucky, United States, 41031
        • Recruiting
        • Cynthiana, KY Investigative Site FIN-10124
        • Contact:
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • FIN-10080, Lexington, KY
        • Contact:
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • Lexington, KY Investigative Site FIN-10118
        • Contact:
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • FIN-10086, Louisville, KY
        • Contact:
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Louisville, KY Investigative Site FIN-10417
        • Contact:
      • Paducah, Kentucky, United States, 42003
        • Recruiting
        • FIN-10079, Paducah, KY
        • Contact:
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • FIN-10030, Baton Rouge, LA
        • Contact:
      • Hammond, Louisiana, United States, 70403
        • Recruiting
        • FIN-10106, Hammond, LA
        • Contact:
      • West Monroe, Louisiana, United States, 71291
        • Recruiting
        • FIN-10090, West Monroe, LA
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Recruiting
        • Minneapolis, MN Investigative Site FIN-10035
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • FIN-10002 Kansas City, MO Investigational Site
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • FIN-10318, Charlotte, NC
        • Contact:
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Greenville, NC Investigative Site FIN-10122
        • Contact:
    • Ohio
      • Akron, Ohio, United States, 44304
        • Recruiting
        • FIN-10081, Akron, OH
        • Contact:
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • FIN-10119, Centerville, OH
        • Contact:
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • FIN- 10112, Cincinnati, OH
        • Contact:
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Recruiting
        • Orangeburg, SC Investigative Site FIN-10433
        • Contact:
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • FIN-10015 Austin, TX Investigational Site
        • Contact:
      • Denison, Texas, United States, 75020
        • Recruiting
        • FIN-10404, Denison, TX
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • FIN-10085, Houston, TX
        • Contact:
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Tyler, TX Investigative Site FIN-10422
        • Contact:
    • Utah
      • Layton, Utah, United States, 84041
        • Recruiting
        • FIN-10405, Layton, UT
        • Contact:
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • FIN-10053, Burlington, VT
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Recruiting
        • FIN-10402, Norfolk, VA
        • Contact:
      • Richmond, Virginia, United States, 23298-5051
        • Recruiting
        • FIN-10093, Richmond, VA
        • Contact:
      • Salem, Virginia, United States, 24153
        • Recruiting
        • Salem, VA Investigative Site FIN-10048
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Milwaukee, WI Investigative Site FIN-10428
        • 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 electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
  • Age ≥18 years or legal age of majority if >18 years in the participant's country of residence
  • Symptomatic HFrEF per protocol defined criteria
  • Not on sMRA due to history of intolerance, contraindication, or ineligibility for treatment
  • Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)

Exclusion Criteria:

  • Treatment with non-steroidal MRA (nsMRA)
  • Documented prior history of severe hyperkalemia in the setting of MRA use
  • eGFR < 25 mL/min/1.73m² and / or potassium > 5.0 mmol/L
  • Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned
  • Prior or planned heart transplant
  • Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure
  • Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
  • Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
  • Probable alternative cause of participant's HF
  • Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers
  • Known hypersensitivity to the IP (active substance or excipients)
  • Any other condition or therapy which would make the participant unsuitable for the study
  • Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first occurrence of cardiovascular (CV) death or HF event.
Time Frame: Ongoing, up to ~30 months
- Time to first CV death or HF event with finerenone compared to placebo.
Ongoing, up to ~30 months
Number of serious adverse events
Time Frame: Ongoing, up to ~30 months
- 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
- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.
Ongoing, up to ~30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Timing and occurrence of total CV deaths and HF events
Time Frame: Ongoing, up to ~30 months
- Timing and occurrence of total (first and subsequent) events of CV death and HF events and CV deaths with finerenone compared to placebo.
Ongoing, up to ~30 months
Timing and occurrence of total HF events
Time Frame: Ongoing, up to ~30 months
Timing and occurrence of total (first and recurrent) HF events with finerenone compared to placebo.
Ongoing, up to ~30 months
Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Month 6.
Time Frame: 180 days
- Change in KCCQ-TSS with finerenone compared to placebo.
180 days
Time to all-cause death.
Time Frame: Ongoing, up to ~30 months
- Time to all-cause mortality 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 Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
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)

August 20, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202304CPC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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