Heart FailurePhase 3FINALITY-HFNCT06033950
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
A Phase 3 study testing Finerenone in people with Heart Failure, run by Colorado Prevention Center at 176 sites in 14 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Finerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,600 participants
- Where
- 176 sitesin 14 countries
- Study dates
- 20 Aug 2024to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
176 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
176 sites in 14 countries
United States54 sites, 54 recruiting
- Recruiting
FIN-10081, Akron, OH
Akron, Ohio, 44304
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10110, Aurora, CO
Aurora, Colorado, 80012
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10001, Aurora, CO
Aurora, Colorado, 80045
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10015 Austin, TX Investigational Site
Austin, Texas, 78705
Bonaca, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10030, Baton Rouge, LA
Baton Rouge, Louisiana, 70808
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Bradenton, FL Investigative Site FIN-10125
Bradenton, Florida, 34209
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10053, Burlington, VT
Burlington, Vermont, 05401
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10119, Centerville, OH
Centerville, Ohio, 45459
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10318, Charlotte, NC
Charlotte, North Carolina, 28207
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Chula Vista, CA Investigative Site FIN-10419
Chula Vista, California, 91910
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Chula Vista, CA Investigative Site FIN-10111
Chula Vista, California, 91911
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN- 10112, Cincinnati, OH
Cincinnati, Ohio, 45219
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Cynthiana, KY Investigative Site FIN-10124
Cynthiana, Kentucky, 41031
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10404, Denison, TX
Denison, Texas, 75020
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10004 Fairhope, AL Investigational Site
Fairhope, Alabama, 36532
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Greenville, NC Investigative Site FIN-10122
Greenville, North Carolina, 27834
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10106, Hammond, LA
Hammond, Louisiana, 70403
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10104, Hialeah, FL
Hialeah, Florida, 33012
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10085, Houston, TX
Houston, Texas, 77030
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10028, Jacksonville, FL
Jacksonville, Florida, 32209
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10002 Kansas City, MO Investigational Site
Kansas City, Missouri, 64111
Bonaca, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10405, Layton, UT
Layton, Utah, 84041
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10080, Lexington, KY
Lexington, Kentucky, 40503
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Lexington, KY Investigative Site FIN-10118
Lexington, Kentucky, 40536
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10086, Louisville, KY
Louisville, Kentucky, 40205
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Louisville, KY Investigative Site FIN-10417
Louisville, Kentucky, 40205
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10064, Merrillville, IN
Merrillville, Indiana, 46410
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10105, Miami, FL
Miami, Florida, 33135
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Milwaukee, WI Investigative Site FIN-10428
Milwaukee, Wisconsin, 53215
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Minneapolis, MN Investigative Site FIN-10035
Minneapolis, Minnesota, 55417
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10113, Miramar, FL
Miramar, Florida, 33027
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10402, Norfolk, VA
Norfolk, Virginia, 23510
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10407, Northridge, CA
Northridge, California, 91324
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10412, Orange, CA
Orange, California, 92866
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Orangeburg, SC Investigative Site FIN-10433
Orangeburg, South Carolina, 29118
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10079, Paducah, KY
Paducah, Kentucky, 42003
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10019, Peoria, IL
Peoria, Illinois, 61603
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Phoenix, AZ Investigative Site FIN-10115
Phoenix, Arizona, 85006
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10070, Pamona, CA
Pomona, California, 91767
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10093, Richmond, VA
Richmond, Virginia, 23298-5051
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10024, Sacramento, CA
Sacramento, California, 95816
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Salem, VA Investigative Site FIN-10048
Salem, Virginia, 24153
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10406, San Diego, CA
San Diego, California, 91127
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
San Diego, CA Investigative Site FIN-10420
San Diego, California, 92111
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10075 San Diego, CA Investigational Site
San Diego, California, 92243
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
San Francisco, CA Investigative Site FIN-10023
San Francisco, California, 94118
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10423, Sherman Oaks, CA
Sherman Oaks, California, 91403
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FON-10409, Tarzana, CA
Tarzana, California, 91356
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Tyler, TX Investigative Site FIN-10422
Tyler, Texas, 75702
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10109, Van Nuys, CA
Van Nuys, California, 91405
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10408, West Covina, CA
West Covina, California, 91790
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10013, West Hills, CA
West Hills, California, 91307
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10090, West Monroe, LA
West Monroe, Louisiana, 71291
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-10401, Yuma, AZ
Yuma, Arizona, 85365
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Brazil44 sites, 44 recruiting
- Recruiting
FIN-21053, Aparecida de Goiânia, Goiás
Aparecida de Goiânia, Goiás, 74936-600
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21058, Aracaju, Sergipe
Aracaju, Sergipe, 49055-210
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Belo Horizonte, Minas Gerais
Belo Horizonte, Minas Gerais, 30110-934
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21071, Belo Horizonte, Minas Gerais
Belo Horizonte, Minas Gerais, 30150-320
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21051, Belo Horizonte, Minas Gerais
Belo Horizonte, Minas Gerais, 30220-140
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Belo Horizonte, Minas Gerais Investigative Site FIN-21079
Belo Horizonte, Minas Gerais, 30220-330
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21013, Belo Horizonte, Minas Gerais
Belo Horizonte, Minas Gerais, 30441-070
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21004 Braganca Paulista, Sao Paulo
Bragança Paulista, São Paulo, 12916542
Bonaca, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21028, Brasilia, Distrito Federal
Brasília, Federal District, 70390-700
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Campinas, São Paulo Investigative Site' FIN-21083
Campinas, São Paulo, 13083-190
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21008, Caxias do Sul, Rio Grande do Sul
Caxias do Sul, Rio Grande do Sul, 95070-560
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21056, Curitiba, Paraná
Curitiba, Paraná, 80060-900
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Fortaleza, Ceará Investigative Site'FIN-21076
Fortaleza, Ceará, 60430275
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Fortaleza, Ceará Investigative Site FIN-21055
Fortaleza, Ceará, 60864-190
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21003 Goiania, Goias Investigational Site
Goiânia, Goiás, 74453-200
Bonaca, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21068, Guarulhos, São Paulo
Guarulhos, São Paulo, 07197-000
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21005, Itaquera, São Paulo
Itaquera, São Paulo, 08270-120
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21007, Joinville, Santa Catarina
Joinville, Santa Catarina, 89200-000
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21047, Londrina, Paraná
Londrina, Paraná, 86.038-350
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21078, Maceió, Alagoas
Maceió, Alagoas, 57051-160
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21024, Natal, Rio Grande do Norte
Natal, Rio Grande do Norte, 5902050
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21010, Osasco, São Paulo
Osasco, São Paulo, 06013-070
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21019, Porto Alegre, Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90840-440
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21011, Presidente Prudente, São Paulo
Presidente Prudente, São Paulo, 19050-680
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21021, Recife, Pernambuco
Recife, Pernambuco, 50100-040
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Recife, Pernambuco Investigative Site FIN-21086
Recife, Pernambuco, 51.110-160
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21061, Recife, Pernambuco
Recife, Pernambuco, 52010-075
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21001, Recife, Recife
Recife, Recife, 50720-110
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21063, Rio Branco, Acre
Rio Branco, Acre, 69915-030
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21016, Rio De Janeiro, Rio De Janeiro
Rio de Janeiro, Rio de Janeiro, 20551-030
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21014, Rio de Janeiro, Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 22240-006
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Rio de Janeiro Investigative Site FIN-21034
Rio de Janeiro, 22280-003
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21072 Salvador, Bahia - BA
Salvador, Bahia - BA, 40290-000
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21032, Salvador, Bahia
Salvador, Estado de Bahia, 40050-410
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21043, Santo André, São Paulo
Santo André, São Paulo, 09090790
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
São Carlos, São Paulo Investigative Site FIN-21075
São Carlos, São Paulo, 13566-448
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
São José dos Campos, São Paulo Investigative Site'FIN-21081
São José dos Campos, São Paulo, 12243000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21074, São Paulo, São Paulo
São Paulo, São Paulo, 01229-010
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21037, São Paulo, São Paulo
São Paulo, São Paulo, 01323-001
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21048, São Paulo, São Paulo
São Paulo, São Paulo, 04004-30
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21049 Sao Paulo, Sao Paulo
São Paulo, São Paulo, 05652-900
Bonaca, +1-303-860-9900, info@cpcmed.org
- Recruiting
São Paulo Investigative Site FIN-21066
São Paulo, 05403-000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Teresina, Piaui Investigative Site FIN-21050
Teresina, Piauí, 64001-450
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-21031, Votuporanga, São Paulo
Votuporanga, São Paulo, 15505-189
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Canada14 sites, 14 recruiting
- Recruiting
Calgary, AB Investigative Site FIN-11009
Calgary, Alberta, T2N 1N4
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11028, Edmonton, AB
Edmonton, Alberta, T5H 4B9
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11011, Edmonton, AB
Edmonton, Alberta, T6G 2B7
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11016, Sudbury, ON
Greater Sudbury, Ontario, P3E 5J1
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11024, Kingston, ON
Kingston, Ontario, K7L 2V7
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11010, London, ON
London, Ontario, N6A 5A5
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11020, North Vancouver, BC
North Vancouver, British Columbia, V7M 2H4
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11007, North York, ON
North York, Ontario, M6B 3H7
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11005, Sherbrooke, QC
Sherbrooke, Quebec, J1H 5N4
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11012 Surrey, BC Investigational Site
Surrey, British Columbia, V3V OC6
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11008, Toronto, ON
Toronto, Ontario, M4N 3M5
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11019, Toronto, ON
Toronto, Ontario, M5B 1W8
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11025, Victoria, BC
Victoria, British Columbia, V8R 1B2
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-11006, Winnipeg, MB
Winnipeg, Manitoba, R2H 2A6
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Spain11 sites, 11 recruiting
- Recruiting
A Coruña, Galicia Investigative Site FIN-38004
A Coruña, Galicia, 15006
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Barcelona Investigative Site FIN-38010
Barcelona, 08907
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Gerona, Cataluña Investigative Site FIN-38017
Girona, Catalonia, 17007
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-38002, Madrid, Madrid
Madrid, Madrid, 28034
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-38011, Madrid, Madrid
Madrid, Madrid, 28046
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-38006, Majadahonda, Madrid
Majadahonda, Madrid, 28222
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-38012, Málaga, Málaga
Málaga, Málaga, 29010
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-38009, Manises, Valencia
Manises, Valencia, 46940
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-38008, Santiago de Compostela, Galicia
Santiago de Compostela, Galicia, 15706
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-38001, Valencia, Valencia
Valencia, Valencia, 46026
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-38007, Valencia, Valencia
Valencia, Valencia, 46026
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Japan9 sites, 9 recruiting
- Recruiting
FIN-57009, Isehara, Kanagawa
Isehara, Kanagawa, 259-1193
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-57005, Iwakuni, Yamaguchi
Iwakuni, Yamaguchi, 740-8510
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-57001, Kyoto, Kyoto
Kyoto, Kyoto, 606-8507
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-57004, Osaka, Osaka
Osaka, Osaka, 530-0005
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-57009, Ota-ku, Tokyo
Ōta-ku, Tokyo, 143-8540
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-57006, Sagamiharam, Kanagawa
Sagamihara, Kanagawa, 252-5188
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-57002, Sapporo, Hokkaido
Sapporo, Hokkaido, 060-8648
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-57003, Sendai, Miyagi
Sendai, Miyagi, 980-8574
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-57007, Suita, Osaka
Suita, Osaka, 564-8565
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Sri Lanka8 sites, 8 recruiting
- Recruiting
Colombo, Western Province Investigative Site FIN-54004
Colombo, Western Province, 01000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Colombo, Western Province Investigative Site FIN-54006
Colombo, Western Province, 01000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Colombo, Western Province Investigative Site FIN-54007
Colombo, Western Province, 10350
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Jaffna, Northern Province Investigative Site FIN-54014
Jaffna, Northern Province, 40000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Kandy, Central Province Investigative Site FIN-54001
Kandy, Central Province, 2000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Kurunegala, Northwestern Province Investigative Site FIN-54013
Kurunegala, Northwestern Province, 60000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Negombo, Western Province Investigative Site FIN-54002
Negombo, Western Province, 11500
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Ragama, Western Province Investigative Site FIN-54008
Ragama, Western Province, 11010
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Argentina7 sites, 7 recruiting
- Recruiting
Buenos Aires Investigative Site FIN-20031
Buenos Aires, 1425
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Córdoba Investigative Site FIN-20025
Córdoba, 5000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Córdoba Investigative Site FIN-20030
Córdoba, 5000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Lanus, Buenos Aires Investigative Site FIN-20024
Lanus, Buenos Aires, 1824
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Rosario, Santa Fe Investigative Site FIN-20022
Rosario, Santa Fe Province, 2300
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
San Juan, San Juan Investigative Site FIN-20020
San Juan, J5402DIL
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
San Juan, San Juan Investigative Site FIN-20021
San Juan, J5402DIL
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Greece7 sites, 7 recruiting
- Recruiting
Alexandroupolis, Evros Investigative Site FIN-33012
Alexandroupoli, Evros, 68100
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Athens, Attica Investigative Site FIN-33004
Athens, Attica, 115 27
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Athens, Attica Investigative Site FIN-33009
Athens, Attica, 155 62
Marc Bonaca, MD, +1-303-860-9900
- Recruiting
Chaidari, Attica Investigative Site FIN-33006
Chaïdári, Attica, 124 62
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Kallithea, Attica Investigative Site FIN-33010
Kallithea, Attica, 176 74
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Nea Ionia, Attica Investigative Site FIN-33007
Nea Ionia, Attica, 142 33
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Thessaloniki, Central Macedonia Investigative Site FIN-33002
Thessaloniki, Central Macedonia, 546 36
Marc Bonaca, MD, +1-303-860-9900
Croatia6 sites, 6 recruiting
- Recruiting
Cepin Investigative Site FIN-30010
Čepin, 31431
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-30004, Krapinske Toplice
Krapinske Toplice, 49217
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Osijek Investigative Site FIN-30008
Osijek, 31000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-30001, Zagreb, Croatia
Zagreb, Croatia, 10000
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-30003, Zagreb, Croatia
Zagreb, Croatia, 10000
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-30007, Zagreb, Croatia
Zagreb, Croatia, 10000
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Poland5 sites, 5 recruiting
- Recruiting
Kraków Investigative Site FIN-37007
Krakow, 30-702
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Łódź Investigative Site FIN-37003
Lodz, 92-213
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-37006, Lublin, Lublin
Lublin, Lublin Voivodeship, 20-011
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-37002, Oswiecim, Oswiecim
Oświęcim, Oswiecim, 32-600
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Tychy, Investigative Site FIN-37009
Tychy, 43-100
Marc Bonaca, MD, +1-303-860-9900
Hungary4 sites, 4 recruiting
- Recruiting
Budapest Investigative Site FIN-34001
Budapest, 1122
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Gyöngyös Investigative Site FIN-34011
Gyöngyös, 3200
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-34004, Nyiregyhaza, Hungary
Nyíregyháza, Hungary, 4400
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Pecs Investigative Site FIN-34006
Pécs, 7624
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
United Kingdom4 sites, 4 recruiting
- Recruiting
FIN-39007, Bristol, UK
Bristol, UK, BS10 5NB
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-39001, Glasgow, UK
Glasgow, G4 0SF
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
London, UK
London, UK, SW17 0QT
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-39006, Southampton, UK
Southampton, SO16 6YD
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Italy2 sites, 2 recruiting
- Recruiting
Brescia, BS Investigative Site FIN-35006
Brescia, BS, 25123
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
FIN-35003, Loc. Germaneto - Catanzaro, CZ
Germaneto, CZ, 88100
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Czechia1 site, 1 recruiting
- Recruiting
FIN-31002, Brno, Czech Republic
Brno, Czech Republic, 612 00
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
About this study
Official title: 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).
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Finerenone, Placebo
- Keywords
- Reduced ejection fraction, Symptomatic heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Oral finerenone.
PlaceboDrug
Matching oral placebo.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Not described Receives: Drug: Finerenone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of cardiovascular (CV) death or HF event.
- Time to first CV death or HF event with finerenone compared to placebo.
Measured: Ongoing, up to ~30 months
Number of serious adverse events
- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Measured: Ongoing, up to ~30 months
Number of adverse events leading to discontinuation of study drug.
- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.
Measured: Ongoing, up to ~30 months
Secondary outcomes (5)
Timing and occurrence of total CV deaths and HF events
- Timing and occurrence of total (first and subsequent) events of CV death and HF events and CV deaths with finerenone compared to placebo.
Measured: Ongoing, up to ~30 months
Timing and occurrence of total HF events
Timing and occurrence of total (first and recurrent) HF events with finerenone compared to placebo.
Measured: Ongoing, up to ~30 months
Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Month 6.
- Change in KCCQ-TSS with finerenone compared to placebo.
Measured: 180 days
Time to CV death.
- Time to CV death with finerenone compared to placebo.
Measured: Ongoing, up to ~30 months
Time to all-cause death.
- Time to all-cause mortality with finerenone compared to placebo.
Measured: Ongoing, up to ~30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start20 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Prevention Center
- Sponsor type
- University, hospital or other
- Collaborators
- St. Luke's Hospital, Kansas City, Missouri, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033950
- Sponsor's protocol ID
- 202304CPC
- Acronym
- FINALITY-HF
- Status last verified
- Jul 2026
- First submitted
- 29 Aug 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06033950
- Acronym / sponsor ID
- FINALITY-HF / 202304CPC
- Conditions
- Heart Failure
- Keywords
- Reduced ejection fraction, Symptomatic heart failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Colorado Prevention CenterUniversity, hospital or other
- Collaborators
- St. Luke's Hospital, Kansas City, Missouri, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: Finerenone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneOral finerenone. | Drug | Finerenone |
| PlaceboMatching oral placebo. | Drug | Placebo |
Primary outcome
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.
Number of serious adverse events
Time frame: Ongoing, up to ~30 months
- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
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.
5 secondary outcomes
Timing and occurrence of total CV deaths and HF events
Time frame: Ongoing, up to ~30 months
Timing and occurrence of total HF events
Time frame: 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
Time to CV death.
Time frame: Ongoing, up to ~30 months
Time to all-cause death.
Time frame: Ongoing, up to ~30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
176 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Finerenone in people with Heart Failure, run by Colorado Prevention Center at 176 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 176 sites in United States, Brazil, Canada, Spain, Japan and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Bonaca ((303) 860-9900, info@cpcmed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first occurrence of cardiovascular (CV) death or HF event. (time frame: Ongoing, up to ~30 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.