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
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)
1 other identifier
interventional
2,600
14 countries
176
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Aug 2024
Typical duration for phase_3 heart-failure
176 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedStudy Start
First participant enrolled
August 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
ExpectedJuly 10, 2026
July 1, 2026
1.9 years
August 29, 2023
July 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Time to first occurrence of cardiovascular (CV) death or HF event.
\- Time to first CV death or HF event with finerenone compared to placebo.
Ongoing, up to ~30 months
Number of serious adverse events
\- 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.
\- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.
Ongoing, up to ~30 months
Secondary Outcomes (5)
Timing and occurrence of total CV deaths and HF events
Ongoing, up to ~30 months
Timing and occurrence of total HF events
Ongoing, up to ~30 months
Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Month 6.
180 days
Time to CV death.
Ongoing, up to ~30 months
Time to all-cause death.
Ongoing, up to ~30 months
Study Arms (2)
Finerenone
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (176)
FIN-10004 Fairhope, AL Investigational Site
Fairhope, Alabama, 36532, United States
Phoenix, AZ Investigative Site FIN-10115
Phoenix, Arizona, 85006, United States
FIN-10401, Yuma, AZ
Yuma, Arizona, 85365, United States
Chula Vista, CA Investigative Site FIN-10419
Chula Vista, California, 91910, United States
Chula Vista, CA Investigative Site FIN-10111
Chula Vista, California, 91911, United States
FIN-10407, Northridge, CA
Northridge, California, 91324, United States
FIN-10412, Orange, CA
Orange, California, 92866, United States
FIN-10070, Pamona, CA
Pomona, California, 91767, United States
FIN-10024, Sacramento, CA
Sacramento, California, 95816, United States
FIN-10406, San Diego, CA
San Diego, California, 91127, United States
San Diego, CA Investigative Site FIN-10420
San Diego, California, 92111, United States
FIN-10075 San Diego, CA Investigational Site
San Diego, California, 92243, United States
San Francisco, CA Investigative Site FIN-10023
San Francisco, California, 94118, United States
FIN-10423, Sherman Oaks, CA
Sherman Oaks, California, 91403, United States
FON-10409, Tarzana, CA
Tarzana, California, 91356, United States
FIN-10109, Van Nuys, CA
Van Nuys, California, 91405, United States
FIN-10408, West Covina, CA
West Covina, California, 91790, United States
FIN-10013, West Hills, CA
West Hills, California, 91307, United States
FIN-10110, Aurora, CO
Aurora, Colorado, 80012, United States
FIN-10001, Aurora, CO
Aurora, Colorado, 80045, United States
Bradenton, FL Investigative Site FIN-10125
Bradenton, Florida, 34209, United States
FIN-10104, Hialeah, FL
Hialeah, Florida, 33012, United States
FIN-10028, Jacksonville, FL
Jacksonville, Florida, 32209, United States
FIN-10105, Miami, FL
Miami, Florida, 33135, United States
FIN-10113, Miramar, FL
Miramar, Florida, 33027, United States
FIN-10019, Peoria, IL
Peoria, Illinois, 61603, United States
FIN-10064, Merrillville, IN
Merrillville, Indiana, 46410, United States
Cynthiana, KY Investigative Site FIN-10124
Cynthiana, Kentucky, 41031, United States
FIN-10080, Lexington, KY
Lexington, Kentucky, 40503, United States
Lexington, KY Investigative Site FIN-10118
Lexington, Kentucky, 40536, United States
FIN-10086, Louisville, KY
Louisville, Kentucky, 40205, United States
Louisville, KY Investigative Site FIN-10417
Louisville, Kentucky, 40205, United States
FIN-10079, Paducah, KY
Paducah, Kentucky, 42003, United States
FIN-10030, Baton Rouge, LA
Baton Rouge, Louisiana, 70808, United States
FIN-10106, Hammond, LA
Hammond, Louisiana, 70403, United States
FIN-10090, West Monroe, LA
West Monroe, Louisiana, 71291, United States
Minneapolis, MN Investigative Site FIN-10035
Minneapolis, Minnesota, 55417, United States
FIN-10002 Kansas City, MO Investigational Site
Kansas City, Missouri, 64111, United States
FIN-10318, Charlotte, NC
Charlotte, North Carolina, 28207, United States
Greenville, NC Investigative Site FIN-10122
Greenville, North Carolina, 27834, United States
FIN-10081, Akron, OH
Akron, Ohio, 44304, United States
FIN-10119, Centerville, OH
Centerville, Ohio, 45459, United States
FIN- 10112, Cincinnati, OH
Cincinnati, Ohio, 45219, United States
Orangeburg, SC Investigative Site FIN-10433
Orangeburg, South Carolina, 29118, United States
FIN-10015 Austin, TX Investigational Site
Austin, Texas, 78705, United States
FIN-10404, Denison, TX
Denison, Texas, 75020, United States
FIN-10085, Houston, TX
Houston, Texas, 77030, United States
Tyler, TX Investigative Site FIN-10422
Tyler, Texas, 75702, United States
FIN-10405, Layton, UT
Layton, Utah, 84041, United States
FIN-10053, Burlington, VT
Burlington, Vermont, 05401, United States
FIN-10402, Norfolk, VA
Norfolk, Virginia, 23510, United States
FIN-10093, Richmond, VA
Richmond, Virginia, 23298-5051, United States
Salem, VA Investigative Site FIN-10048
Salem, Virginia, 24153, United States
Milwaukee, WI Investigative Site FIN-10428
Milwaukee, Wisconsin, 53215, United States
Lanus, Buenos Aires Investigative Site FIN-20024
Lanus, Buenos Aires, 1824, Argentina
Rosario, Santa Fe Investigative Site FIN-20022
Rosario, Santa Fe Province, 2300, Argentina
Buenos Aires Investigative Site FIN-20031
Buenos Aires, 1425, Argentina
Córdoba Investigative Site FIN-20025
Córdoba, 5000, Argentina
Córdoba Investigative Site FIN-20030
Córdoba, 5000, Argentina
San Juan, San Juan Investigative Site FIN-20020
San Juan, J5402DIL, Argentina
San Juan, San Juan Investigative Site FIN-20021
San Juan, J5402DIL, Argentina
FIN-21063, Rio Branco, Acre
Rio Branco, Acre, 69915-030, Brazil
FIN-21078, Maceió, Alagoas
Maceió, Alagoas, 57051-160, Brazil
FIN-21072 Salvador, Bahia - BA
Salvador, Bahia - BA, 40290-000, Brazil
Fortaleza, Ceará Investigative Site'FIN-21076
Fortaleza, Ceará, 60430275, Brazil
Fortaleza, Ceará Investigative Site FIN-21055
Fortaleza, Ceará, 60864-190, Brazil
FIN-21032, Salvador, Bahia
Salvador, Estado de Bahia, 40050-410, Brazil
FIN-21028, Brasilia, Distrito Federal
Brasília, Federal District, 70390-700, Brazil
FIN-21053, Aparecida de Goiânia, Goiás
Aparecida de Goiânia, Goiás, 74936-600, Brazil
FIN-21003 Goiania, Goias Investigational Site
Goiânia, Goiás, 74453-200, Brazil
Belo Horizonte, Minas Gerais
Belo Horizonte, Minas Gerais, 30110-934, Brazil
FIN-21071, Belo Horizonte, Minas Gerais
Belo Horizonte, Minas Gerais, 30150-320, Brazil
FIN-21051, Belo Horizonte, Minas Gerais
Belo Horizonte, Minas Gerais, 30220-140, Brazil
Belo Horizonte, Minas Gerais Investigative Site FIN-21079
Belo Horizonte, Minas Gerais, 30220-330, Brazil
FIN-21013, Belo Horizonte, Minas Gerais
Belo Horizonte, Minas Gerais, 30441-070, Brazil
FIN-21056, Curitiba, Paraná
Curitiba, Paraná, 80060-900, Brazil
FIN-21047, Londrina, Paraná
Londrina, Paraná, 86.038-350, Brazil
FIN-21021, Recife, Pernambuco
Recife, Pernambuco, 50100-040, Brazil
Recife, Pernambuco Investigative Site FIN-21086
Recife, Pernambuco, 51.110-160, Brazil
FIN-21061, Recife, Pernambuco
Recife, Pernambuco, 52010-075, Brazil
Teresina, Piaui Investigative Site FIN-21050
Teresina, Piauí, 64001-450, Brazil
FIN-21001, Recife, Recife
Recife, Recife, 50720-110, Brazil
FIN-21016, Rio De Janeiro, Rio De Janeiro
Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
FIN-21014, Rio de Janeiro, Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 22240-006, Brazil
FIN-21024, Natal, Rio Grande do Norte
Natal, Rio Grande do Norte, 5902050, Brazil
FIN-21008, Caxias do Sul, Rio Grande do Sul
Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
FIN-21019, Porto Alegre, Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90840-440, Brazil
FIN-21007, Joinville, Santa Catarina
Joinville, Santa Catarina, 89200-000, Brazil
FIN-21058, Aracaju, Sergipe
Aracaju, Sergipe, 49055-210, Brazil
FIN-21004 Braganca Paulista, Sao Paulo
Bragança Paulista, São Paulo, 12916542, Brazil
Campinas, São Paulo Investigative Site' FIN-21083
Campinas, São Paulo, 13083-190, Brazil
FIN-21068, Guarulhos, São Paulo
Guarulhos, São Paulo, 07197-000, Brazil
FIN-21005, Itaquera, São Paulo
Itaquera, São Paulo, 08270-120, Brazil
FIN-21010, Osasco, São Paulo
Osasco, São Paulo, 06013-070, Brazil
FIN-21011, Presidente Prudente, São Paulo
Presidente Prudente, São Paulo, 19050-680, Brazil
FIN-21043, Santo André, São Paulo
Santo André, São Paulo, 09090790, Brazil
São Carlos, São Paulo Investigative Site FIN-21075
São Carlos, São Paulo, 13566-448, Brazil
São José dos Campos, São Paulo Investigative Site'FIN-21081
São José dos Campos, São Paulo, 12243000, Brazil
FIN-21074, São Paulo, São Paulo
São Paulo, São Paulo, 01229-010, Brazil
FIN-21037, São Paulo, São Paulo
São Paulo, São Paulo, 01323-001, Brazil
FIN-21048, São Paulo, São Paulo
São Paulo, São Paulo, 04004-30, Brazil
FIN-21049 Sao Paulo, Sao Paulo
São Paulo, São Paulo, 05652-900, Brazil
FIN-21031, Votuporanga, São Paulo
Votuporanga, São Paulo, 15505-189, Brazil
Rio de Janeiro Investigative Site FIN-21034
Rio de Janeiro, 22280-003, Brazil
São Paulo Investigative Site FIN-21066
São Paulo, 05403-000, Brazil
Calgary, AB Investigative Site FIN-11009
Calgary, Alberta, T2N 1N4, Canada
FIN-11028, Edmonton, AB
Edmonton, Alberta, T5H 4B9, Canada
FIN-11011, Edmonton, AB
Edmonton, Alberta, T6G 2B7, Canada
FIN-11020, North Vancouver, BC
North Vancouver, British Columbia, V7M 2H4, Canada
FIN-11012 Surrey, BC Investigational Site
Surrey, British Columbia, V3V OC6, Canada
FIN-11025, Victoria, BC
Victoria, British Columbia, V8R 1B2, Canada
FIN-11006, Winnipeg, MB
Winnipeg, Manitoba, R2H 2A6, Canada
FIN-11016, Sudbury, ON
Greater Sudbury, Ontario, P3E 5J1, Canada
FIN-11024, Kingston, ON
Kingston, Ontario, K7L 2V7, Canada
FIN-11010, London, ON
London, Ontario, N6A 5A5, Canada
FIN-11007, North York, ON
North York, Ontario, M6B 3H7, Canada
FIN-11008, Toronto, ON
Toronto, Ontario, M4N 3M5, Canada
FIN-11019, Toronto, ON
Toronto, Ontario, M5B 1W8, Canada
FIN-11005, Sherbrooke, QC
Sherbrooke, Quebec, J1H 5N4, Canada
FIN-30001, Zagreb, Croatia
Zagreb, Croatia, 10000, Croatia
FIN-30003, Zagreb, Croatia
Zagreb, Croatia, 10000, Croatia
FIN-30007, Zagreb, Croatia
Zagreb, Croatia, 10000, Croatia
Cepin Investigative Site FIN-30010
Čepin, 31431, Croatia
FIN-30004, Krapinske Toplice
Krapinske Toplice, 49217, Croatia
Osijek Investigative Site FIN-30008
Osijek, 31000, Croatia
FIN-31002, Brno, Czech Republic
Brno, Czech Republic, 612 00, Czechia
Athens, Attica Investigative Site FIN-33004
Athens, Attica, 115 27, Greece
Athens, Attica Investigative Site FIN-33009
Athens, Attica, 155 62, Greece
Chaidari, Attica Investigative Site FIN-33006
Chaïdári, Attica, 124 62, Greece
Kallithea, Attica Investigative Site FIN-33010
Kallithea, Attica, 176 74, Greece
Nea Ionia, Attica Investigative Site FIN-33007
Nea Ionia, Attica, 142 33, Greece
Thessaloniki, Central Macedonia Investigative Site FIN-33002
Thessaloniki, Central Macedonia, 546 36, Greece
Alexandroupolis, Evros Investigative Site FIN-33012
Alexandroupoli, Evros, 68100, Greece
FIN-34004, Nyiregyhaza, Hungary
Nyíregyháza, Hungary, 4400, Hungary
Budapest Investigative Site FIN-34001
Budapest, 1122, Hungary
Gyöngyös Investigative Site FIN-34011
Gyöngyös, 3200, Hungary
Pecs Investigative Site FIN-34006
Pécs, 7624, Hungary
Brescia, BS Investigative Site FIN-35006
Brescia, BS, 25123, Italy
FIN-35003, Loc. Germaneto - Catanzaro, CZ
Germaneto, CZ, 88100, Italy
FIN-57002, Sapporo, Hokkaido
Sapporo, Hokkaido, 060-8648, Japan
FIN-57009, Isehara, Kanagawa
Isehara, Kanagawa, 259-1193, Japan
FIN-57006, Sagamiharam, Kanagawa
Sagamihara, Kanagawa, 252-5188, Japan
FIN-57001, Kyoto, Kyoto
Kyoto, Kyoto, 606-8507, Japan
FIN-57003, Sendai, Miyagi
Sendai, Miyagi, 980-8574, Japan
FIN-57004, Osaka, Osaka
Osaka, Osaka, 530-0005, Japan
FIN-57007, Suita, Osaka
Suita, Osaka, 564-8565, Japan
FIN-57009, Ota-ku, Tokyo
Ōta-ku, Tokyo, 143-8540, Japan
FIN-57005, Iwakuni, Yamaguchi
Iwakuni, Yamaguchi, 740-8510, Japan
FIN-37006, Lublin, Lublin
Lublin, Lublin Voivodeship, 20-011, Poland
FIN-37002, Oswiecim, Oswiecim
Oświęcim, Oswiecim, 32-600, Poland
Kraków Investigative Site FIN-37007
Krakow, 30-702, Poland
Łódź Investigative Site FIN-37003
Lodz, 92-213, Poland
Tychy, Investigative Site FIN-37009
Tychy, 43-100, Poland
Gerona, Cataluña Investigative Site FIN-38017
Girona, Catalonia, 17007, Spain
A Coruña, Galicia Investigative Site FIN-38004
A Coruña, Galicia, 15006, Spain
FIN-38008, Santiago de Compostela, Galicia
Santiago de Compostela, Galicia, 15706, Spain
FIN-38002, Madrid, Madrid
Madrid, Madrid, 28034, Spain
FIN-38011, Madrid, Madrid
Madrid, Madrid, 28046, Spain
FIN-38006, Majadahonda, Madrid
Majadahonda, Madrid, 28222, Spain
FIN-38012, Málaga, Málaga
Málaga, Málaga, 29010, Spain
FIN-38009, Manises, Valencia
Manises, Valencia, 46940, Spain
FIN-38001, Valencia, Valencia
Valencia, Valencia, 46026, Spain
FIN-38007, Valencia, Valencia
Valencia, Valencia, 46026, Spain
Barcelona Investigative Site FIN-38010
Barcelona, 08907, Spain
Kandy, Central Province Investigative Site FIN-54001
Kandy, Central Province, 2000, Sri Lanka
Jaffna, Northern Province Investigative Site FIN-54014
Jaffna, Northern Province, 40000, Sri Lanka
Kurunegala, Northwestern Province Investigative Site FIN-54013
Kurunegala, Northwestern Province, 60000, Sri Lanka
Colombo, Western Province Investigative Site FIN-54004
Colombo, Western Province, 01000, Sri Lanka
Colombo, Western Province Investigative Site FIN-54006
Colombo, Western Province, 01000, Sri Lanka
Colombo, Western Province Investigative Site FIN-54007
Colombo, Western Province, 10350, Sri Lanka
Negombo, Western Province Investigative Site FIN-54002
Negombo, Western Province, 11500, Sri Lanka
Ragama, Western Province Investigative Site FIN-54008
Ragama, Western Province, 11010, Sri Lanka
FIN-39007, Bristol, UK
Bristol, UK, BS10 5NB, United Kingdom
London, UK
London, UK, SW17 0QT, United Kingdom
FIN-39001, Glasgow, UK
Glasgow, G4 0SF, United Kingdom
FIN-39006, Southampton, UK
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2023
First Posted
September 13, 2023
Study Start
August 20, 2024
Primary Completion
August 1, 2026
Study Completion (Estimated)
January 1, 2028
Last Updated
July 10, 2026
Record last verified: 2026-07