A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment... | NCT06033950 | Trialant

A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment... | NCT06033950 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

FIN-10004 Fairhope, AL Investigational SiteRecruiting

Fairhope, Alabama 36532, United States

Bonaca, MDContact

info@cpcmed.org+1-303-860-9900

Phoenix, AZ Investigative Site FIN-10115Recruiting

Phoenix, Arizona 85006, United States

FIN-10401, Yuma, AZRecruiting

Yuma, Arizona 85365, United States

Chula Vista, CA Investigative Site FIN-10419Recruiting

Chula Vista, California 91910, United States

Chula Vista, CA Investigative Site FIN-10111Recruiting

Chula Vista, California 91911, United States

FIN-10407, Northridge, CARecruiting

Northridge, California 91324, United States

FIN-10412, Orange, CARecruiting

Orange, California 92866, United States

FIN-10070, Pamona, CARecruiting

Pomona, California 91767, United States

FIN-10024, Sacramento, CARecruiting

Sacramento, California 95816, United States

FIN-10406, San Diego, CARecruiting

San Diego, California 91127, United States

San Diego, CA Investigative Site FIN-10420Recruiting

San Diego, California 92111, United States

FIN-10075 San Diego, CA Investigational SiteRecruiting

San Diego, California 92243, United States

San Francisco, CA Investigative Site FIN-10023Recruiting

San Francisco, California 94118, United States

FIN-10423, Sherman Oaks, CARecruiting

Sherman Oaks, California 91403, United States

FON-10409, Tarzana, CARecruiting

Tarzana, California 91356, United States

FIN-10109, Van Nuys, CARecruiting

Van Nuys, California 91405, United States

FIN-10408, West Covina, CARecruiting

West Covina, California 91790, United States

FIN-10013, West Hills, CARecruiting

West Hills, California 91307, United States

FIN-10110, Aurora, CORecruiting

Aurora, Colorado 80012, United States

FIN-10001, Aurora, CORecruiting

Aurora, Colorado 80045, United States

Bradenton, FL Investigative Site FIN-10125Recruiting

Bradenton, Florida 34209, United States

FIN-10104, Hialeah, FLRecruiting

Hialeah, Florida 33012, United States

FIN-10028, Jacksonville, FLRecruiting

Jacksonville, Florida 32209, United States

FIN-10105, Miami, FLRecruiting

Miami, Florida 33135, United States

FIN-10113, Miramar, FLRecruiting

Miramar, Florida 33027, United States

FIN-10019, Peoria, ILRecruiting

Peoria, Illinois 61603, United States

FIN-10064, Merrillville, INRecruiting

Merrillville, Indiana 46410, United States

Cynthiana, KY Investigative Site FIN-10124Recruiting

Cynthiana, Kentucky 41031, United States

FIN-10080, Lexington, KYRecruiting

Lexington, Kentucky 40503, United States

Lexington, KY Investigative Site FIN-10118Recruiting

Lexington, Kentucky 40536, United States

FIN-10086, Louisville, KYRecruiting

Louisville, Kentucky 40205, United States

Louisville, KY Investigative Site FIN-10417Recruiting

Louisville, Kentucky 40205, United States

FIN-10079, Paducah, KYRecruiting

Paducah, Kentucky 42003, United States

FIN-10030, Baton Rouge, LARecruiting

Baton Rouge, Louisiana 70808, United States

FIN-10106, Hammond, LARecruiting

Hammond, Louisiana 70403, United States

FIN-10090, West Monroe, LARecruiting

West Monroe, Louisiana 71291, United States

Minneapolis, MN Investigative Site FIN-10035Recruiting

Minneapolis, Minnesota 55417, United States

FIN-10002 Kansas City, MO Investigational SiteRecruiting

Kansas City, Missouri 64111, United States

FIN-10318, Charlotte, NCRecruiting

Charlotte, North Carolina 28207, United States

Greenville, NC Investigative Site FIN-10122Recruiting

Greenville, North Carolina 27834, United States

FIN-10081, Akron, OHRecruiting

Akron, Ohio 44304, United States

FIN-10119, Centerville, OHRecruiting

Centerville, Ohio 45459, United States

FIN- 10112, Cincinnati, OHRecruiting

Cincinnati, Ohio 45219, United States

Orangeburg, SC Investigative Site FIN-10433Recruiting

Orangeburg, South Carolina 29118, United States

FIN-10015 Austin, TX Investigational SiteRecruiting

Austin, Texas 78705, United States

FIN-10404, Denison, TXRecruiting

Denison, Texas 75020, United States

FIN-10085, Houston, TXRecruiting

Houston, Texas 77030, United States

Tyler, TX Investigative Site FIN-10422Recruiting

Tyler, Texas 75702, United States

FIN-10405, Layton, UTRecruiting

Layton, Utah 84041, United States

FIN-10053, Burlington, VTRecruiting

Burlington, Vermont 05401, United States

FIN-10402, Norfolk, VARecruiting

Norfolk, Virginia 23510, United States

FIN-10093, Richmond, VARecruiting

Richmond, Virginia 23298-5051, United States

Salem, VA Investigative Site FIN-10048Recruiting

Salem, Virginia 24153, United States

Milwaukee, WI Investigative Site FIN-10428Recruiting

Milwaukee, Wisconsin 53215, United States

Lanus, Buenos Aires Investigative Site FIN-20024Recruiting

Lanus, Buenos Aires 1824, Argentina

Rosario, Santa Fe Investigative Site FIN-20022Recruiting

Rosario, Santa Fe Province 2300, Argentina

Buenos Aires Investigative Site FIN-20031Recruiting

Buenos Aires, 1425, Argentina

Córdoba Investigative Site FIN-20025Recruiting

Córdoba, 5000, Argentina

Córdoba Investigative Site FIN-20030Recruiting

Córdoba, 5000, Argentina

San Juan, San Juan Investigative Site FIN-20020Recruiting

San Juan, J5402DIL, Argentina

San Juan, San Juan Investigative Site FIN-20021Recruiting

San Juan, J5402DIL, Argentina

FIN-21063, Rio Branco, AcreRecruiting

Rio Branco, Acre 69915-030, Brazil

FIN-21078, Maceió, AlagoasRecruiting

Maceió, Alagoas 57051-160, Brazil

FIN-21072 Salvador, Bahia - BARecruiting

Salvador, Bahia - BA 40290-000, Brazil

Fortaleza, Ceará Investigative Site'FIN-21076Recruiting

Fortaleza, Ceará 60430275, Brazil

Fortaleza, Ceará Investigative Site FIN-21055Recruiting

Fortaleza, Ceará 60864-190, Brazil

FIN-21032, Salvador, BahiaRecruiting

Salvador, Estado de Bahia 40050-410, Brazil

FIN-21028, Brasilia, Distrito FederalRecruiting

Brasília, Federal District 70390-700, Brazil

FIN-21053, Aparecida de Goiânia, GoiásRecruiting

Aparecida de Goiânia, Goiás 74936-600, Brazil

FIN-21003 Goiania, Goias Investigational SiteRecruiting

Goiânia, Goiás 74453-200, Brazil

Belo Horizonte, Minas GeraisRecruiting

Belo Horizonte, Minas Gerais 30110-934, Brazil

FIN-21071, Belo Horizonte, Minas GeraisRecruiting

Belo Horizonte, Minas Gerais 30150-320, Brazil

FIN-21051, Belo Horizonte, Minas GeraisRecruiting

Belo Horizonte, Minas Gerais 30220-140, Brazil

Belo Horizonte, Minas Gerais Investigative Site FIN-21079Recruiting

Belo Horizonte, Minas Gerais 30220-330, Brazil

FIN-21013, Belo Horizonte, Minas GeraisRecruiting

Belo Horizonte, Minas Gerais 30441-070, Brazil

FIN-21056, Curitiba, ParanáRecruiting

Curitiba, Paraná 80060-900, Brazil

FIN-21047, Londrina, ParanáRecruiting

Londrina, Paraná 86.038-350, Brazil

FIN-21021, Recife, PernambucoRecruiting

Recife, Pernambuco 50100-040, Brazil

Recife, Pernambuco Investigative Site FIN-21086Recruiting

Recife, Pernambuco 51.110-160, Brazil

FIN-21061, Recife, PernambucoRecruiting

Recife, Pernambuco 52010-075, Brazil

Teresina, Piaui Investigative Site FIN-21050Recruiting

Teresina, Piauí 64001-450, Brazil

FIN-21001, Recife, RecifeRecruiting

Recife, Recife 50720-110, Brazil

FIN-21016, Rio De Janeiro, Rio De JaneiroRecruiting

Rio de Janeiro, Rio de Janeiro 20551-030, Brazil

FIN-21014, Rio de Janeiro, Rio de JaneiroRecruiting

Rio de Janeiro, Rio de Janeiro 22240-006, Brazil

FIN-21024, Natal, Rio Grande do NorteRecruiting

Natal, Rio Grande do Norte 5902050, Brazil

FIN-21008, Caxias do Sul, Rio Grande do SulRecruiting

Caxias do Sul, Rio Grande do Sul 95070-560, Brazil

FIN-21019, Porto Alegre, Rio Grande do SulRecruiting

Porto Alegre, Rio Grande do Sul 90840-440, Brazil

FIN-21007, Joinville, Santa CatarinaRecruiting

Joinville, Santa Catarina 89200-000, Brazil

FIN-21058, Aracaju, SergipeRecruiting

Aracaju, Sergipe 49055-210, Brazil

FIN-21004 Braganca Paulista, Sao PauloRecruiting

Bragança Paulista, São Paulo 12916542, Brazil

Campinas, São Paulo Investigative Site' FIN-21083Recruiting

Campinas, São Paulo 13083-190, Brazil

FIN-21068, Guarulhos, São PauloRecruiting

Guarulhos, São Paulo 07197-000, Brazil

FIN-21005, Itaquera, São PauloRecruiting

Itaquera, São Paulo 08270-120, Brazil

FIN-21010, Osasco, São PauloRecruiting

Osasco, São Paulo 06013-070, Brazil

FIN-21011, Presidente Prudente, São PauloRecruiting

Presidente Prudente, São Paulo 19050-680, Brazil

FIN-21043, Santo André, São PauloRecruiting

Santo André, São Paulo 09090790, Brazil

São Carlos, São Paulo Investigative Site FIN-21075Recruiting

São Carlos, São Paulo 13566-448, Brazil

São José dos Campos, São Paulo Investigative Site'FIN-21081Recruiting

São José dos Campos, São Paulo 12243000, Brazil

FIN-21074, São Paulo, São PauloRecruiting

São Paulo, São Paulo 01229-010, Brazil

FIN-21037, São Paulo, São PauloRecruiting

São Paulo, São Paulo 01323-001, Brazil

FIN-21048, São Paulo, São PauloRecruiting

São Paulo, São Paulo 04004-30, Brazil

FIN-21049 Sao Paulo, Sao PauloRecruiting

São Paulo, São Paulo 05652-900, Brazil

FIN-21031, Votuporanga, São PauloRecruiting

Votuporanga, São Paulo 15505-189, Brazil

Rio de Janeiro Investigative Site FIN-21034Recruiting

Rio de Janeiro, 22280-003, Brazil

São Paulo Investigative Site FIN-21066Recruiting

São Paulo, 05403-000, Brazil

Calgary, AB Investigative Site FIN-11009Recruiting

Calgary, Alberta T2N 1N4, Canada

FIN-11028, Edmonton, ABRecruiting

Edmonton, Alberta T5H 4B9, Canada

FIN-11011, Edmonton, ABRecruiting

Edmonton, Alberta T6G 2B7, Canada

FIN-11020, North Vancouver, BCRecruiting

North Vancouver, British Columbia V7M 2H4, Canada

FIN-11012 Surrey, BC Investigational SiteRecruiting

Surrey, British Columbia V3V OC6, Canada

FIN-11025, Victoria, BCRecruiting

Victoria, British Columbia V8R 1B2, Canada

FIN-11006, Winnipeg, MBRecruiting

Winnipeg, Manitoba R2H 2A6, Canada

FIN-11016, Sudbury, ONRecruiting

Greater Sudbury, Ontario P3E 5J1, Canada

FIN-11024, Kingston, ONRecruiting

Kingston, Ontario K7L 2V7, Canada

FIN-11010, London, ONRecruiting

London, Ontario N6A 5A5, Canada

FIN-11007, North York, ONRecruiting

North York, Ontario M6B 3H7, Canada

Bonaca, MDContact

info@cpcmed.org+1-303-860-9900

FIN-11008, Toronto, ONRecruiting

Toronto, Ontario M4N 3M5, Canada

FIN-11019, Toronto, ONRecruiting

Toronto, Ontario M5B 1W8, Canada

FIN-11005, Sherbrooke, QCRecruiting

Sherbrooke, Quebec J1H 5N4, Canada

FIN-30001, Zagreb, CroatiaRecruiting

Zagreb, Croatia 10000, Croatia

FIN-30003, Zagreb, CroatiaRecruiting

Zagreb, Croatia 10000, Croatia

FIN-30007, Zagreb, CroatiaRecruiting

Zagreb, Croatia 10000, Croatia

Cepin Investigative Site FIN-30010Recruiting

Čepin, 31431, Croatia

FIN-30004, Krapinske TopliceRecruiting

Krapinske Toplice, 49217, Croatia

Osijek Investigative Site FIN-30008Recruiting

Osijek, 31000, Croatia

FIN-31002, Brno, Czech RepublicRecruiting

Brno, Czech Republic 612 00, Czechia

Athens, Attica Investigative Site FIN-33004Recruiting

Athens, Attica 115 27, Greece

Athens, Attica Investigative Site FIN-33009Recruiting

Athens, Attica 155 62, Greece

Chaidari, Attica Investigative Site FIN-33006Recruiting

Chaïdári, Attica 124 62, Greece

Kallithea, Attica Investigative Site FIN-33010Recruiting

Kallithea, Attica 176 74, Greece

Nea Ionia, Attica Investigative Site FIN-33007Recruiting

Nea Ionia, Attica 142 33, Greece

Thessaloniki, Central Macedonia Investigative Site FIN-33002Recruiting

Thessaloniki, Central Macedonia 546 36, Greece

Alexandroupolis, Evros Investigative Site FIN-33012Recruiting

Alexandroupoli, Evros 68100, Greece

FIN-34004, Nyiregyhaza, HungaryRecruiting

Nyíregyháza, Hungary 4400, Hungary

Budapest Investigative Site FIN-34001Recruiting

Budapest, 1122, Hungary

Gyöngyös Investigative Site FIN-34011Recruiting

Gyöngyös, 3200, Hungary

Pecs Investigative Site FIN-34006Recruiting

Pécs, 7624, Hungary

Brescia, BS Investigative Site FIN-35006Recruiting

Brescia, BS 25123, Italy

FIN-35003, Loc. Germaneto - Catanzaro, CZRecruiting

Germaneto, CZ 88100, Italy

FIN-57002, Sapporo, HokkaidoRecruiting

Sapporo, Hokkaido 060-8648, Japan

FIN-57009, Isehara, KanagawaRecruiting

Isehara, Kanagawa 259-1193, Japan

FIN-57006, Sagamiharam, KanagawaRecruiting

Sagamihara, Kanagawa 252-5188, Japan

FIN-57001, Kyoto, KyotoRecruiting

Kyoto, Kyoto 606-8507, Japan

FIN-57003, Sendai, MiyagiRecruiting

Sendai, Miyagi 980-8574, Japan

FIN-57004, Osaka, OsakaRecruiting

Osaka, Osaka 530-0005, Japan

FIN-57007, Suita, OsakaRecruiting

Suita, Osaka 564-8565, Japan

FIN-57009, Ota-ku, TokyoRecruiting

Ōta-ku, Tokyo 143-8540, Japan

FIN-57005, Iwakuni, YamaguchiRecruiting

Iwakuni, Yamaguchi 740-8510, Japan

FIN-37006, Lublin, LublinRecruiting

Lublin, Lublin Voivodeship 20-011, Poland

FIN-37002, Oswiecim, OswiecimRecruiting

Oświęcim, Oswiecim 32-600, Poland

Kraków Investigative Site FIN-37007Recruiting

Krakow, 30-702, Poland

Łódź Investigative Site FIN-37003Recruiting

Lodz, 92-213, Poland

Tychy, Investigative Site FIN-37009Recruiting

Tychy, 43-100, Poland

Gerona, Cataluña Investigative Site FIN-38017Recruiting

Girona, Catalonia 17007, Spain

A Coruña, Galicia Investigative Site FIN-38004Recruiting

A Coruña, Galicia 15006, Spain

FIN-38008, Santiago de Compostela, GaliciaRecruiting

Santiago de Compostela, Galicia 15706, Spain

FIN-38002, Madrid, MadridRecruiting

Madrid, Madrid 28034, Spain

FIN-38011, Madrid, MadridRecruiting

Madrid, Madrid 28046, Spain

FIN-38006, Majadahonda, MadridRecruiting

Majadahonda, Madrid 28222, Spain

FIN-38012, Málaga, MálagaRecruiting

Málaga, Málaga 29010, Spain

FIN-38009, Manises, ValenciaRecruiting

Manises, Valencia 46940, Spain

FIN-38001, Valencia, ValenciaRecruiting

Valencia, Valencia 46026, Spain

FIN-38007, Valencia, ValenciaRecruiting

Valencia, Valencia 46026, Spain

Barcelona Investigative Site FIN-38010Recruiting

Barcelona, 08907, Spain

Kandy, Central Province Investigative Site FIN-54001Recruiting

Kandy, Central Province 2000, Sri Lanka

Jaffna, Northern Province Investigative Site FIN-54014Recruiting

Jaffna, Northern Province 40000, Sri Lanka

Kurunegala, Northwestern Province Investigative Site FIN-54013Recruiting

Kurunegala, Northwestern Province 60000, Sri Lanka

Colombo, Western Province Investigative Site FIN-54004Recruiting

Colombo, Western Province 01000, Sri Lanka

Colombo, Western Province Investigative Site FIN-54006Recruiting

Colombo, Western Province 01000, Sri Lanka

Colombo, Western Province Investigative Site FIN-54007Recruiting

Colombo, Western Province 10350, Sri Lanka

Negombo, Western Province Investigative Site FIN-54002Recruiting

Negombo, Western Province 11500, Sri Lanka

Ragama, Western Province Investigative Site FIN-54008Recruiting

Ragama, Western Province 11010, Sri Lanka

FIN-39007, Bristol, UKRecruiting

Bristol, UK BS10 5NB, United Kingdom

London, UKRecruiting

London, UK SW17 0QT, United Kingdom

FIN-39001, Glasgow, UKRecruiting

Glasgow, G4 0SF, United Kingdom

FIN-39006, Southampton, UKRecruiting

Southampton, SO16 6YD, United Kingdom