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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

NCT06033950 · Colorado Prevention Center
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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)
About this study
This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced ejection fraction.
Eligibility criteria
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 design
Enrollment target: 2600 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-08-20
Estimated completion: 2028-01
Last updated: 2026-07-10
Interventions
Drug: FinerenoneDrug: Placebo
Primary outcomes
  • Time to first occurrence of cardiovascular (CV) death or HF event. (Ongoing, up to ~30 months)
  • Number of serious adverse events (Ongoing, up to ~30 months)
  • Number of adverse events leading to discontinuation of study drug. (Ongoing, up to ~30 months)
Sponsor
Colorado Prevention Center · other
With: St. Luke's Hospital, Kansas City, Missouri, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Contacts & investigators
ContactMarc Bonaca · contact · info@cpcmed.org · (303) 860-9900
All locations (176)
FIN-10004 Fairhope, AL Investigational SiteRecruiting
Fairhope, Alabama, United States
Phoenix, AZ Investigative Site FIN-10115Recruiting
Phoenix, Arizona, United States
FIN-10401, Yuma, AZRecruiting
Yuma, Arizona, United States
Chula Vista, CA Investigative Site FIN-10419Recruiting
Chula Vista, California, United States
Chula Vista, CA Investigative Site FIN-10111Recruiting
Chula Vista, California, United States
FIN-10407, Northridge, CARecruiting
Northridge, California, United States
FIN-10412, Orange, CARecruiting
Orange, California, United States
FIN-10070, Pamona, CARecruiting
Pomona, California, United States
FIN-10024, Sacramento, CARecruiting
Sacramento, California, United States
FIN-10406, San Diego, CARecruiting
San Diego, California, United States
San Diego, CA Investigative Site FIN-10420Recruiting
San Diego, California, United States
FIN-10075 San Diego, CA Investigational SiteRecruiting
San Diego, California, United States
San Francisco, CA Investigative Site FIN-10023Recruiting
San Francisco, California, United States
FIN-10423, Sherman Oaks, CARecruiting
Sherman Oaks, California, United States
FON-10409, Tarzana, CARecruiting
Tarzana, California, United States
FIN-10109, Van Nuys, CARecruiting
Van Nuys, California, United States
FIN-10408, West Covina, CARecruiting
West Covina, California, United States
FIN-10013, West Hills, CARecruiting
West Hills, California, United States
FIN-10110, Aurora, CORecruiting
Aurora, Colorado, United States
FIN-10001, Aurora, CORecruiting
Aurora, Colorado, United States
Bradenton, FL Investigative Site FIN-10125Recruiting
Bradenton, Florida, United States
FIN-10104, Hialeah, FLRecruiting
Hialeah, Florida, United States
FIN-10028, Jacksonville, FLRecruiting
Jacksonville, Florida, United States
FIN-10105, Miami, FLRecruiting
Miami, Florida, United States
FIN-10113, Miramar, FLRecruiting
Miramar, Florida, United States
FIN-10019, Peoria, ILRecruiting
Peoria, Illinois, United States
FIN-10064, Merrillville, INRecruiting
Merrillville, Indiana, United States
Cynthiana, KY Investigative Site FIN-10124Recruiting
Cynthiana, Kentucky, United States
FIN-10080, Lexington, KYRecruiting
Lexington, Kentucky, United States
Lexington, KY Investigative Site FIN-10118Recruiting
Lexington, Kentucky, United States
FIN-10086, Louisville, KYRecruiting
Louisville, Kentucky, United States
Louisville, KY Investigative Site FIN-10417Recruiting
Louisville, Kentucky, United States
FIN-10079, Paducah, KYRecruiting
Paducah, Kentucky, United States
FIN-10030, Baton Rouge, LARecruiting
Baton Rouge, Louisiana, United States
FIN-10106, Hammond, LARecruiting
Hammond, Louisiana, United States
FIN-10090, West Monroe, LARecruiting
West Monroe, Louisiana, United States
Minneapolis, MN Investigative Site FIN-10035Recruiting
Minneapolis, Minnesota, United States
FIN-10002 Kansas City, MO Investigational SiteRecruiting
Kansas City, Missouri, United States
FIN-10318, Charlotte, NCRecruiting
Charlotte, North Carolina, United States
Greenville, NC Investigative Site FIN-10122Recruiting
Greenville, North Carolina, United States
FIN-10081, Akron, OHRecruiting
Akron, Ohio, United States
FIN-10119, Centerville, OHRecruiting
Centerville, Ohio, United States
FIN- 10112, Cincinnati, OHRecruiting
Cincinnati, Ohio, United States
Orangeburg, SC Investigative Site FIN-10433Recruiting
Orangeburg, South Carolina, United States
FIN-10015 Austin, TX Investigational SiteRecruiting
Austin, Texas, United States
FIN-10404, Denison, TXRecruiting
Denison, Texas, United States
FIN-10085, Houston, TXRecruiting
Houston, Texas, United States
Tyler, TX Investigative Site FIN-10422Recruiting
Tyler, Texas, United States
FIN-10405, Layton, UTRecruiting
Layton, Utah, United States
FIN-10053, Burlington, VTRecruiting
Burlington, Vermont, United States
FIN-10402, Norfolk, VARecruiting
Norfolk, Virginia, United States
FIN-10093, Richmond, VARecruiting
Richmond, Virginia, United States
Salem, VA Investigative Site FIN-10048Recruiting
Salem, Virginia, United States
Milwaukee, WI Investigative Site FIN-10428Recruiting
Milwaukee, Wisconsin, United States
Lanus, Buenos Aires Investigative Site FIN-20024Recruiting
Lanus, Buenos Aires, Argentina
Rosario, Santa Fe Investigative Site FIN-20022Recruiting
Rosario, Santa Fe Province, Argentina
Buenos Aires Investigative Site FIN-20031Recruiting
Buenos Aires, Argentina
Córdoba Investigative Site FIN-20025Recruiting
Córdoba, Argentina
Córdoba Investigative Site FIN-20030Recruiting
Córdoba, Argentina
San Juan, San Juan Investigative Site FIN-20020Recruiting
San Juan, Argentina
San Juan, San Juan Investigative Site FIN-20021Recruiting
San Juan, Argentina
FIN-21063, Rio Branco, AcreRecruiting
Rio Branco, Acre, Brazil
FIN-21078, Maceió, AlagoasRecruiting
Maceió, Alagoas, Brazil
FIN-21072 Salvador, Bahia - BARecruiting
Salvador, Bahia - BA, Brazil
Fortaleza, Ceará Investigative Site'FIN-21076Recruiting
Fortaleza, Ceará, Brazil
Fortaleza, Ceará Investigative Site FIN-21055Recruiting
Fortaleza, Ceará, Brazil
FIN-21032, Salvador, BahiaRecruiting
Salvador, Estado de Bahia, Brazil
FIN-21028, Brasilia, Distrito FederalRecruiting
Brasília, Federal District, Brazil
FIN-21053, Aparecida de Goiânia, GoiásRecruiting
Aparecida de Goiânia, Goiás, Brazil
FIN-21003 Goiania, Goias Investigational SiteRecruiting
Goiânia, Goiás, Brazil
Belo Horizonte, Minas GeraisRecruiting
Belo Horizonte, Minas Gerais, Brazil
FIN-21071, Belo Horizonte, Minas GeraisRecruiting
Belo Horizonte, Minas Gerais, Brazil
FIN-21051, Belo Horizonte, Minas GeraisRecruiting
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais Investigative Site FIN-21079Recruiting
Belo Horizonte, Minas Gerais, Brazil
FIN-21013, Belo Horizonte, Minas GeraisRecruiting
Belo Horizonte, Minas Gerais, Brazil
FIN-21056, Curitiba, ParanáRecruiting
Curitiba, Paraná, Brazil
FIN-21047, Londrina, ParanáRecruiting
Londrina, Paraná, Brazil
FIN-21021, Recife, PernambucoRecruiting
Recife, Pernambuco, Brazil
Recife, Pernambuco Investigative Site FIN-21086Recruiting
Recife, Pernambuco, Brazil
FIN-21061, Recife, PernambucoRecruiting
Recife, Pernambuco, Brazil
Teresina, Piaui Investigative Site FIN-21050Recruiting
Teresina, Piauí, Brazil
FIN-21001, Recife, RecifeRecruiting
Recife, Recife, Brazil
FIN-21016, Rio De Janeiro, Rio De JaneiroRecruiting
Rio de Janeiro, Rio de Janeiro, Brazil
FIN-21014, Rio de Janeiro, Rio de JaneiroRecruiting
Rio de Janeiro, Rio de Janeiro, Brazil
FIN-21024, Natal, Rio Grande do NorteRecruiting
Natal, Rio Grande do Norte, Brazil
FIN-21008, Caxias do Sul, Rio Grande do SulRecruiting
Caxias do Sul, Rio Grande do Sul, Brazil
FIN-21019, Porto Alegre, Rio Grande do SulRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
FIN-21007, Joinville, Santa CatarinaRecruiting
Joinville, Santa Catarina, Brazil
FIN-21058, Aracaju, SergipeRecruiting
Aracaju, Sergipe, Brazil
FIN-21004 Braganca Paulista, Sao PauloRecruiting
Bragança Paulista, São Paulo, Brazil
Campinas, São Paulo Investigative Site' FIN-21083Recruiting
Campinas, São Paulo, Brazil
FIN-21068, Guarulhos, São PauloRecruiting
Guarulhos, São Paulo, Brazil
FIN-21005, Itaquera, São PauloRecruiting
Itaquera, São Paulo, Brazil
FIN-21010, Osasco, São PauloRecruiting
Osasco, São Paulo, Brazil
FIN-21011, Presidente Prudente, São PauloRecruiting
Presidente Prudente, São Paulo, Brazil
FIN-21043, Santo André, São PauloRecruiting
Santo André, São Paulo, Brazil
São Carlos, São Paulo Investigative Site FIN-21075Recruiting
São Carlos, São Paulo, Brazil
São José dos Campos, São Paulo Investigative Site'FIN-21081Recruiting
São José dos Campos, São Paulo, Brazil
FIN-21074, São Paulo, São PauloRecruiting
São Paulo, São Paulo, Brazil
FIN-21037, São Paulo, São PauloRecruiting
São Paulo, São Paulo, Brazil
FIN-21048, São Paulo, São PauloRecruiting
São Paulo, São Paulo, Brazil
FIN-21049 Sao Paulo, Sao PauloRecruiting
São Paulo, São Paulo, Brazil
FIN-21031, Votuporanga, São PauloRecruiting
Votuporanga, São Paulo, Brazil
Rio de Janeiro Investigative Site FIN-21034Recruiting
Rio de Janeiro, Brazil
São Paulo Investigative Site FIN-21066Recruiting
São Paulo, Brazil
Calgary, AB Investigative Site FIN-11009Recruiting
Calgary, Alberta, Canada
FIN-11028, Edmonton, ABRecruiting
Edmonton, Alberta, Canada
FIN-11011, Edmonton, ABRecruiting
Edmonton, Alberta, Canada
FIN-11020, North Vancouver, BCRecruiting
North Vancouver, British Columbia, Canada
FIN-11012 Surrey, BC Investigational SiteRecruiting
Surrey, British Columbia, Canada
FIN-11025, Victoria, BCRecruiting
Victoria, British Columbia, Canada
FIN-11006, Winnipeg, MBRecruiting
Winnipeg, Manitoba, Canada
FIN-11016, Sudbury, ONRecruiting
Greater Sudbury, Ontario, Canada
FIN-11024, Kingston, ONRecruiting
Kingston, Ontario, Canada
FIN-11010, London, ONRecruiting
London, Ontario, Canada
FIN-11007, North York, ONRecruiting
North York, Ontario, Canada
FIN-11008, Toronto, ONRecruiting
Toronto, Ontario, Canada
FIN-11019, Toronto, ONRecruiting
Toronto, Ontario, Canada
FIN-11005, Sherbrooke, QCRecruiting
Sherbrooke, Quebec, Canada
FIN-30001, Zagreb, CroatiaRecruiting
Zagreb, Croatia, Croatia
FIN-30003, Zagreb, CroatiaRecruiting
Zagreb, Croatia, Croatia
FIN-30007, Zagreb, CroatiaRecruiting
Zagreb, Croatia, Croatia
Cepin Investigative Site FIN-30010Recruiting
Čepin, Croatia
FIN-30004, Krapinske TopliceRecruiting
Krapinske Toplice, Croatia
Osijek Investigative Site FIN-30008Recruiting
Osijek, Croatia
FIN-31002, Brno, Czech RepublicRecruiting
Brno, Czech Republic, Czechia
Athens, Attica Investigative Site FIN-33004Recruiting
Athens, Attica, Greece
Athens, Attica Investigative Site FIN-33009Recruiting
Athens, Attica, Greece
Chaidari, Attica Investigative Site FIN-33006Recruiting
Chaïdári, Attica, Greece
Kallithea, Attica Investigative Site FIN-33010Recruiting
Kallithea, Attica, Greece
Nea Ionia, Attica Investigative Site FIN-33007Recruiting
Nea Ionia, Attica, Greece
Thessaloniki, Central Macedonia Investigative Site FIN-33002Recruiting
Thessaloniki, Central Macedonia, Greece
Alexandroupolis, Evros Investigative Site FIN-33012Recruiting
Alexandroupoli, Evros, Greece
FIN-34004, Nyiregyhaza, HungaryRecruiting
Nyíregyháza, Hungary, Hungary
Budapest Investigative Site FIN-34001Recruiting
Budapest, Hungary
Gyöngyös Investigative Site FIN-34011Recruiting
Gyöngyös, Hungary
Pecs Investigative Site FIN-34006Recruiting
Pécs, Hungary
Brescia, BS Investigative Site FIN-35006Recruiting
Brescia, BS, Italy
FIN-35003, Loc. Germaneto - Catanzaro, CZRecruiting
Germaneto, CZ, Italy
FIN-57002, Sapporo, HokkaidoRecruiting
Sapporo, Hokkaido, Japan
FIN-57009, Isehara, KanagawaRecruiting
Isehara, Kanagawa, Japan
FIN-57006, Sagamiharam, KanagawaRecruiting
Sagamihara, Kanagawa, Japan
FIN-57001, Kyoto, KyotoRecruiting
Kyoto, Kyoto, Japan
FIN-57003, Sendai, MiyagiRecruiting
Sendai, Miyagi, Japan
FIN-57004, Osaka, OsakaRecruiting
Osaka, Osaka, Japan
FIN-57007, Suita, OsakaRecruiting
Suita, Osaka, Japan
FIN-57009, Ota-ku, TokyoRecruiting
Ōta-ku, Tokyo, Japan
FIN-57005, Iwakuni, YamaguchiRecruiting
Iwakuni, Yamaguchi, Japan
FIN-37006, Lublin, LublinRecruiting
Lublin, Lublin Voivodeship, Poland
FIN-37002, Oswiecim, OswiecimRecruiting
Oświęcim, Oswiecim, Poland
Kraków Investigative Site FIN-37007Recruiting
Krakow, Poland
Łódź Investigative Site FIN-37003Recruiting
Lodz, Poland
Tychy, Investigative Site FIN-37009Recruiting
Tychy, Poland
Gerona, Cataluña Investigative Site FIN-38017Recruiting
Girona, Catalonia, Spain
A Coruña, Galicia Investigative Site FIN-38004Recruiting
A Coruña, Galicia, Spain
FIN-38008, Santiago de Compostela, GaliciaRecruiting
Santiago de Compostela, Galicia, Spain
FIN-38002, Madrid, MadridRecruiting
Madrid, Madrid, Spain
FIN-38011, Madrid, MadridRecruiting
Madrid, Madrid, Spain
FIN-38006, Majadahonda, MadridRecruiting
Majadahonda, Madrid, Spain
FIN-38012, Málaga, MálagaRecruiting
Málaga, Málaga, Spain
FIN-38009, Manises, ValenciaRecruiting
Manises, Valencia, Spain
FIN-38001, Valencia, ValenciaRecruiting
Valencia, Valencia, Spain
FIN-38007, Valencia, ValenciaRecruiting
Valencia, Valencia, Spain
Barcelona Investigative Site FIN-38010Recruiting
Barcelona, Spain
Kandy, Central Province Investigative Site FIN-54001Recruiting
Kandy, Central Province, Sri Lanka
Jaffna, Northern Province Investigative Site FIN-54014Recruiting
Jaffna, Northern Province, Sri Lanka
Kurunegala, Northwestern Province Investigative Site FIN-54013Recruiting
Kurunegala, Northwestern Province, Sri Lanka
Colombo, Western Province Investigative Site FIN-54004Recruiting
Colombo, Western Province, Sri Lanka
Colombo, Western Province Investigative Site FIN-54006Recruiting
Colombo, Western Province, Sri Lanka
Colombo, Western Province Investigative Site FIN-54007Recruiting
Colombo, Western Province, Sri Lanka
Negombo, Western Province Investigative Site FIN-54002Recruiting
Negombo, Western Province, Sri Lanka
Ragama, Western Province Investigative Site FIN-54008Recruiting
Ragama, Western Province, Sri Lanka
FIN-39007, Bristol, UKRecruiting
Bristol, UK, United Kingdom
London, UKRecruiting
London, UK, United Kingdom
FIN-39001, Glasgow, UKRecruiting
Glasgow, United Kingdom
FIN-39006, Southampton, UKRecruiting
Southampton, United Kingdom