A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

NCT06008197 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 202301CPC
• Study Type: interventional
• Target: 5,200
• Locations: 22 countries
• Sites: 299

Brief Summary

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

Conditions

Heart Failure; Acute Heart Failure

Keywords

Heart failure; Preserved ejection fraction; Mildly reduced ejection fraction; Hospitalized

Outcome Measures

Primary Outcomes (3)

• Composite of total HF events and cardiovascular (CV) death.

  Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.

  Ongoing, up to ~30 months

• Number of serious adverse events.

  Occurrence of 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.

  Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.

  Ongoing, up to ~30 months

Secondary Outcomes (5)

• Time to first occurrence of the composite of CV death or HF event.

  Ongoing, up to ~30 months

• Total HF events.

  Ongoing, up to ~30 months

• Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.

  6 Months

• Time to CV death.

  Ongoing, up to ~30 months

• Time to death from any cause.

  Ongoing, up to ~30 months

Study Arms (2)

Finerenone

EXPERIMENTAL

Drug: Finerenone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Finerenone DRUG

Oral finerenone

Also known as: Kerendia, Firialta

Finerenone

Placebo DRUG

Matching oral placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent
• Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence
• Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure
• Heart failure signs and symptoms at the time of hospital admission
• Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
• Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF

You may not qualify if:

• Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA)
• Documented prior history of severe hyperkalemia in the setting of MRA use
• Estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73m² or potassium \>5.0 mmol/L at screening
• Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
• Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
• Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction
• Probable alternative cause of participant's heart failure symptoms
• Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
• Known hypersensitivity to the IP (active substance or excipients)

Sponsors & Collaborators

• Colorado Prevention Center: lead
• St. Luke's Hospital, Kansas City, Missouri: collaborator
• Bayer: collaborator

Study Sites (299)

Birmingham, AL Investigative Site 10012

Birmingham, Alabama, 35205, United States

RECRUITING

Fairhope, AL Investigative Site 10004

Fairhope, Alabama, 36532, United States

RECRUITING

Huntsville, AL Investigative Site 10026

Huntsville, Alabama, 35801, United States

RECRUITING

Glendale, AZ Investigative Site 10096

Glendale, Arizona, 85304, United States

RECRUITING

Scottsdale, AZ Investigative Site 10003

Scottsdale, Arizona, 85258, United States

RECRUITING

Chula Vista, CA Investigative Site 10111

Chula Vista, California, 91911, United States

RECRUITING

Huntington Beach, CA Investigative Site 10031

Huntington Beach, California, 92648, United States

RECRUITING

Los Angeles, CA Investigative Site 10089

Los Angeles, California, 90073, United States

RECRUITING

Sacramento, CA Investigative Site 10024

Sacramento, California, 95816, United States

RECRUITING

San Francisco, CA Investigative Site 10023

San Francisco, California, 94118, United States

RECRUITING

Tarzana, CA Investigative Site 10409

Tarzana, California, 91356, United States

RECRUITING

Van Nuys, CA Investigative Site 10109

Van Nuys, California, 91405, United States

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West Hills, CA Investigative Site 10013

West Hills, California, 91307, United States

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Aurora, CO Investigative Site 10001

Aurora, Colorado, 80045, United States

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Denver, CO Investigative Site 10005

Denver, Colorado, 80204, United States

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Bradenton, FL Investigative Site 10125

Bradenton, Florida, 34209, United States

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Brooksville, FL Investigative Site 10077

Brooksville, Florida, 34613, United States

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Fort Lauderdale, FL Investigative Site 10114

Fort Lauderdale, Florida, 33308, United States

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Fort Myers, FL Investigative Site 10076

Fort Myers, Florida, 33919, United States

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Hialeah, FL Investigative Site 10104

Hialeah, Florida, 33012, United States

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Jacksonville, FL Investigative Site 10028

Jacksonville, Florida, 32209, United States

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Miami, FL Investigative Site 10105

Miami, Florida, 33135, United States

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Miami, FL Investigative Site 10040

Miami, Florida, 33173, United States

RECRUITING

Miramar, FL Investigative Site 10113

Miramar, Florida, 33027, United States

NOT YET RECRUITING

Atlanta, GA Investigative Site 10022

Atlanta, Georgia, 30303, United States

RECRUITING

Duluth, GA Investigative Site 10083

Duluth, Georgia, 30096, United States

RECRUITING

Boise, Idaho Investigative Site 10073

Boise, Idaho, 83712, United States

RECRUITING

Chicago, IL Investigative Site 10062

Chicago, Illinois, 60612, United States

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Glenview, IL Investigative Site 10021

Glenview, Illinois, 60026, United States

RECRUITING

Naperville, IL Investigative Site 10025

Naperville, Illinois, 60540, United States

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Peoria, IL Investigative Site 10019

Peoria, Illinois, 61603, United States

RECRUITING

Peoria, IL Investigative Site 10010

Peoria, Illinois, 61614, United States

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Indianapolis, IN Investigative Site 10074

Indianapolis, Indiana, 46237, United States

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Indianapolis, IN Investigative Site 10008

Indianapolis, Indiana, 46260, United States

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Merrillville, IN Investigative Site 10064

Merrillville, Indiana, 46410, United States

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Kansas City, KS Investigative Site 10060

Kansas City, Kansas, 66103, United States

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Lexington, KY Investigative Site 10080

Lexington, Kentucky, 40503, United States

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Lexington, KY Investigative Site 10118

Lexington, Kentucky, 40536, United States

RECRUITING

Louisville, KY Investigative Site 10006

Louisville, Kentucky, 40202, United States

RECRUITING

Louisville, KY Investigative Site 10086

Louisville, Kentucky, 40205, United States

NOT YET RECRUITING

Paducah, KY Investigative Site 10079

Paducah, Kentucky, 42003, United States

RECRUITING

Baton Rouge, LA Investigative Site 10030

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Hammond, LA Investigative Site 10106

Hammond, Louisiana, 70403, United States

RECRUITING

West Monroe, LA Investigative Site 10090

West Monroe, Louisiana, 71291, United States

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Baltimore, MD Investigative Site 10101

Baltimore, Maryland, 21287, United States

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Bowie, MD Investigative Site 10020

Bowie, Maryland, 20715, United States

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Boston, MA Investigative Stie 10087

Boston, Massachusetts, 02114, United States

RECRUITING

Minneapolis, MN Investigative Site 10091

Minneapolis, Minnesota, 55407-1139, United States

RECRUITING

Minneapolis, MN Investigative Site 10035

Minneapolis, Minnesota, 55417, United States

RECRUITING

Tupelo, MS Investigative Site 10100

Tupelo, Mississippi, 38801, United States

NOT YET RECRUITING

Kansas City, MO Investigative Site 10002

Kansas City, Missouri, 64111, United States

RECRUITING

Omaha, NE Investigative Site 10018

Omaha, Nebraska, 68105, United States

RECRUITING

Camden, NJ Investigative Site 10033

Camden, New Jersey, 08103, United States

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Roslyn, NY Investigative Site 10058

Roslyn, New York, 11576, United States

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Stony Brook, NY Investigative Site 10017

Stony Brook, New York, 11794-8171, United States

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Akron, OH Investigative Site 10081

Akron, Ohio, 44304, United States

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Centerville, OH Investigative Site 10119

Centerville, Ohio, 45459, United States

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Cincinnati, OH Investigative Site 10088

Cincinnati, Ohio, 45220, United States

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Bartlesville, OK Investigative Site 10095

Bartlesville, Oklahoma, 74006, United States

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Philadelphia, PA Investigative Site 10068

Philadelphia, Pennsylvania, 19107, United States

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Pittsburg, PA Investigative Site 1044

Pittsburgh, Pennsylvania, 15212, United States

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Providence, RI Investigative Site 10050

Providence, Rhode Island, 02908, United States

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Charleston, SC Investigative Site 10056

Charleston, South Carolina, 29425, United States

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Germantown, TN Investigative Site 10063

Germantown, Tennessee, 38138, United States

RECRUITING

Memphis, TN Investigative Site 10059

Memphis, Tennessee, 38105, United States

RECRUITING

Nashville, TN Investigative Site 10071

Nashville, Tennessee, 37203, United States

RECRUITING

Amarillo, TX Investigative Site 10045

Amarillo, Texas, 79106, United States

RECRUITING

Austin, TX Investigative Site 10015

Austin, Texas, 78705, United States

RECRUITING

Dallas, TX Investigative Site 10042

Dallas, Texas, 75216, United States

RECRUITING

Houston, TX Investigative Site 10085

Houston, Texas, 77030, United States

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Plano, TX Investigative Site 10014

Plano, Texas, 75093, United States

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Burlington, VT Investigative Site 10053

Burlington, Vermont, 05401, United States

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Norfolk, VA Investigative Site 10009

Norfolk, Virginia, 23507, United States

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Richmond, VA Investigative Site 10069

Richmond, Virginia, 23225, United States

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Richmond, VA Investigative Site 10067

Richmond, Virginia, 23249, United States

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Salem, VA Investigative Site 10048

Salem, Virginia, 24153, United States

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Milwaukee, WI Investigative Site 10061

Milwaukee, Wisconsin, 53226, United States

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Buenos Aires Investigative Site 20017

Buenos Aires, Buenos Aires, 1180, Argentina

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Buenos Aires Investigative Site 20009

Buenos Aires, Buenos Aires, C1437JC, Argentina

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La Plata, Buenos Aires Investigative Site 20023

La Plata, Buenos Aires, 1904, Argentina

RECRUITING

Lanús, Buenos Aires Investigative Site 20024

Lanus, Buenos Aires, 1824, Argentina

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Corrientes Investigative Site 20001

Corrientes, Corrientes Province, W3400AMZ, Argentina

RECRUITING

Córdoba Investigative Site 20025

Córdoba, Córdoba Province, 5000, Argentina

RECRUITING

Córdoba Investigative Site 20012

Córdoba, Córdoba Province, 5002, Argentina

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Córdoba Investigative Site 20013

Córdoba, Córdoba Province, 5003, Argentina

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Córdoba Investigative Site 20016

Córdoba, Córdoba Province, 5003, Argentina

RECRUITING

Córdoba, Córdoba Investigative Site 20014

Córdoba, Córdoba Province, 5003, Argentina

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Salta Investigative Site 20006

Salta, Salta Province, 4400, Argentina

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San Juan, San Juan Investigative Site 20021

San Juan, San Juan Province, 5400, Argentina

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San Juan, San Juan Investigative Site 20020

San Juan, San Juan Province, J5402, Argentina

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Rafaela, Santa Fe Investigative Site 20026

Rafaela, Santa Fe Province, 2300, Argentina

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Rosario, Santa Fe Investigative Site 20003

Rosario, Santa Fe Province, 2000, Argentina

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Rosario, Santa Fe Investigative Site 20022

Rosario, Santa Fe Province, 2000, Argentina

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Rosario, Santa Fe Investigative Site 20027

Rosario, Santa Fe Province, 5000, Argentina

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Rosario, Santa Fe Investigative Site 20019

Rosario, Santa Fe Province, S2000CVD, Argentina

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Buenos Aires City Investigative Site 20002

Buenos Aires, 1120, Argentina

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Córdoba Investigative Site 20005

Córdoba, 5004, Argentina

RECRUITING

Blacktown, NSW Investigative Site 50006

Blacktown, New South Wales, 2148, Australia

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Milton, Queensland Investigative Site 50001

Milton, Queensland, 4064, Australia

RECRUITING

Elizabeth Vale, South Australia Investigative Site 50008

Elizabeth Vale, South Australia, 5112, Australia

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Melbourne, VIC Investigative Site 50005

Melbourne, Victoria, 3121, Australia

RECRUITING

Mulgrave, Victoria Investigative Site 50004

Mulgrave, Victoria, 3170, Australia

RECRUITING

Rio Branco, Acre Investigative Site 21063

Rio Branco, Acre, 69915-030, Brazil

RECRUITING

Arapiraca, Alagoas Investigative Site 21064

Arapiraca, Alagoas, 57315-745, Brazil

RECRUITING

Fortaleza, Ceará Investigative Site 21055

Fortaleza, Ceará I, 60864-190, Brazil

ACTIVE NOT RECRUITING

Centro Linhares, Espirito Santo Investigative Site 21017

Linhares, Espírito Santo, 29900-010, Brazil

RECRUITING

Vila Velha, Espírito Santo Investigative Site 21059

Vila Velha, Espírito Santo, 29118-060, Brazil

RECRUITING

Salvador, Bahia Investigative Site 21032

Salvador, Estado de Bahia, 40050-410, Brazil

RECRUITING

Brasília, Distrito Federal Investigative Site 21028

Brasília, Federal District, 70390-700, Brazil

RECRUITING

Aparecida de Goiânia, Goiás Investigative Site 21053

Aparecida de Goiânia, Goiás, 74936-600, Brazil

RECRUITING

Goiânia, Goiás Investigative Site 21003

Goiânia, Goiás, 74453-200, Brazil

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Belo Horizonte, Minais Gerais Investigative Site 21013

Belo Horizonte, Minais Gerais, 30441-070, Brazil

RECRUITING

Belo Horizonte, Minas Gerais Investigative Site 21020

Belo Horizonte, Minas Gerais, 30180-080, Brazil

RECRUITING

Belo Horizonte, Minas Gerais Investigative Site 21051

Belo Horizonte, Minas Gerais, 30220140, Brazil

RECRUITING

Poços de Caldas, Minas Gerais Investigative Site 21009

Poços de Caldas, Minas Gerais, 37706-106, Brazil

RECRUITING

Curitiba, Parana Investigative Site 21029

Curitiba, Paraná, 80010-030, Brazil

RECRUITING

Curitiba, Paraná Investigative Site 21056

Curitiba, Paraná, 80060-900, Brazil

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Curitiba, Paraná Investigative Site 21038

Curitiba, Paraná, 80230-130, Brazil

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Londrina, Paraná Investigative Site 21047

Londrina, Paraná, 86.038-350, Brazil

RECRUITING

Recife, Pernambuco Investigative Site 21061

Recife, Pernambuco, 52010-075, Brazil

RECRUITING

Teresina, Piaui Investigative Site 21050

Teresina, Piauí, 64001-450, Brazil

RECRUITING

Recife, Recife Investigative Site 21001

Recife, Recife, 50720-110, Brazil

RECRUITING

Rio De Janeiro, Rio De Janeiro Investigative Site 21016

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

RECRUITING

Rio de Janeiro Investigative Site 21034

Rio de Janeiro, Rio de Janeiro, 22280-003, Brazil

RECRUITING

Natal, Rio Grande do Norte Investigative Site 21024

Natal, Rio Grande do Norte, 5902050, Brazil

RECRUITING

Passo Fundo, Rio Grande do Sul Investigative Site 21042

Passo Fundo, Rio Grande do Sul, 99010 080, Brazil

RECRUITING

Porto Alegre, RS Investigative Site 21060

Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

RECRUITING

Porto Alegre, Rio Grande do Sul Investigative Site 21025

Porto Alegre, Rio Grande do Sul, 90630-165, Brazil

RECRUITING

Porto Alegre, RS Investigative Site 21019

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

RECRUITING

Caxias do Sul, Rio Grande do Sull Investigative Site 21008

Caxias do Sul, Rio Grande Do Sull, 95070560, Brazil

RECRUITING

JOINVILLE, Santa Catarina Investigative Site 21007

Joinville, Santa Catarina, 89204250, Brazil

RECRUITING

São José, Santa Catarina Investigative Site 21002

São José, Santa Catarina, 88103-450, Brazil

RECRUITING

Aracaju, Sergipe Investigative Site 21058

Aracaju, Sergipe, 409055-000, Brazil

RECRUITING

Aracaju, Sergipe Investigative Site 21015

Aracaju, Sergipe, 49055-530, Brazil

RECRUITING

Atibaia, São Paulo Investigative Site 21057

Atibaia, São Paulo, 12944-060, Brazil

RECRUITING

Bragança Paulista, São Paulo Investigative Site 21004

Bragança Paulista, São Paulo, 12916542, Brazil

RECRUITING

Itaquera, São Paulo Investigative Site 21005

Itaquera, São Paulo, 08270-120, Brazil

RECRUITING

Osasco, São Paulo Investigative Site 21010

Osasco, São Paulo, 06013-070, Brazil

RECRUITING

Presidente Prudente, São Paulo Investigative Site 21011

Presidente Prudente, São Paulo, 19050-680, Brazil

RECRUITING

Santo André, Sao Paulo Investigative Site 21043

Santo André, São Paulo, 09090790, Brazil

NOT YET RECRUITING

São Carlos, São Paulo Investigative Site 21075

São Carlos, São Paulo, 13566-448, Brazil

RECRUITING

São José Dos Campos, Sao Paulo Investigative Site 21012

São José dos Campos, São Paulo, 12230-001, Brazil

RECRUITING

São Paulo Investigative Site 21074

São Paulo, São Paulo, 01229-010, Brazil

RECRUITING

São Paulo Investigative Site 21054

São Paulo, São Paulo, 01308-070, Brazil

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São Paulo, São Paulo Investigative Site 21062

São Paulo, São Paulo, 01317002, Brazil

RECRUITING

São Paulo Investigative Site 21037

São Paulo, São Paulo, 01323-001, Brazil

RECRUITING

São Paulo, São Paulo Investigative Site 21048

São Paulo, São Paulo, 04004-30, Brazil

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São Paulo, São Paulo Investigative Site 21041

São Paulo, São Paulo, 04550-000, Brazil

RECRUITING

São Paulo, São Paulo Investigative Site 21035

São Paulo, São Paulo, 04696040, Brazil

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São Paulo, São Paulo Investigative Site 21049

São Paulo, São Paulo, 05652900, Brazil

RECRUITING

Votuporanga, São Paulo Investigative Site 21031

Votuporanga, São Paulo, 15505-189, Brazil

RECRUITING

São Paulo Investigative Site 21066

São Paulo, 05403-000, Brazil

RECRUITING

Calgary, AB Investigative Site 11009

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Edmonton, AB Investigative Site 11018

Edmonton, Alberta, T5H 3V9, Canada

RECRUITING

Edmonton, Alberta Investigative Site 11011

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Kamloops, BC Investigative Site 11021

Kamloops, British Columbia, V2C 2T1, Canada

RECRUITING

North Vancouver, BC Investigative Site11020

North Vancouver, British Columbia, V7M2H4, Canada

NOT YET RECRUITING

Surrey, British Columbia Investigative Site 11012

Surrey, British Columbia, V3V 0C6, Canada

RECRUITING

Vancouver, BC Investigative Site 11017

Vancouver, British Columbia, V6E 1M7, Canada

RECRUITING

Winnipeg, MB Investigative Site 11006

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

Cambridge, ON Investigative Site 11003

Cambridge, Ontario, N1R6V6, Canada

RECRUITING

Sudbury, ON Investigative Site 11016

Greater Sudbury, Ontario, P3E 5J1, Canada

RECRUITING

London, ON Investigative Site 11010

London, Ontario, N6A 5A5, Canada

RECRUITING

North York, Ontario Investigative Site 11007

North York, Ontario, M6B3H7, Canada

RECRUITING

Toronto, Ontario Investigative Site 11008

Toronto, Ontario, M4N3M5, Canada

RECRUITING

Toronto, ON Investigative Site 11019

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Toronto, ON Investigative Site 11001

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Sherbrooke, QC Investigative Site 11005

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Regina, SK Investigative Site 11022

Regina, Saskatchewan, S4P 0W5, Canada

RECRUITING

Zagreb Investigative Site 30007

Zagreb, City of Zagreb, 1000, Croatia

RECRUITING

Zagreb, Grad Zagreb Investigative Site 30005

Zagreb, Croatia, 10000, Croatia

RECRUITING

Rijeka Investigative Site 30009

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

RECRUITING

Krapinske Toplice Investigative Site 30004

Krapinske Toplice, 49217, Croatia

RECRUITING

Osijek Investigative Site 30008

Osijek, 31000, Croatia

RECRUITING

Varazdin Investigative Site 30002

Varaždin, 42000, Croatia

RECRUITING

Zagreb Investigative Site 30001

Zagreb, 10000, Croatia

RECRUITING

Zagreb Investigative Site 30003

Zagreb, 10000, Croatia

RECRUITING

Zagreb Investigative Site 30006

Zagreb, 10000, Croatia

RECRUITING

Chlumec nad Cidlinou, Czech Republic Investigative Site 31005

Chlumec nad Cidlinou, Czech Republic, 30100, Czechia

RECRUITING

Plzeň, Czech Republic Investigative Site 31006

Pilsen, Czech Republic, 30100, Czechia

RECRUITING

Brno-Zidenice Investigative Site 31011

Brno, Zidenice, 615 00, Czechia

RECRUITING

Brno Investigative Site 31002

Brno, 612 00, Czechia

RECRUITING

Praha 4 Investigative Site 31003

Prague, 140 21, Czechia

RECRUITING

Lübeck Investigative Site 32006

Lübeck, Lübeck, 23538, Germany

RECRUITING

Berlin, Berlin Investigative Site 32001

Berlin, State of Berlin, 13353, Germany

RECRUITING

Jena Investigative Site 32004

Jena, Thuringia, 07747, Germany

RECRUITING

Dresden Investigative Site 32003

Dresden, 01067, Germany

RECRUITING

Giessen Investigative Site 32005

Giessen, 35392, Germany

RECRUITING

Regensburg Investigative Site 32002

Regensburg, 93053, Germany

RECRUITING

Athens, Attica Investigative Site 33001

Athens, Attica, 115 27, Greece

RECRUITING

Athens, Attica Investigative Site 33004

Athens, Attica, 115 27, Greece

RECRUITING

Athens, Attica Investigative Site 33005

Athens, Attica, 151 23, Greece

RECRUITING

Chaidari, Attica Investigative Site 33006

Chaïdári, Attica, 124 62, Greece

RECRUITING

Thessaloniki, Central Macedonia Investigative Site 33002

Thessaloniki, Central Macedonia, 546 36, Greece

RECRUITING

Athens, Investigative Site 33007

Athens, Greece, 14233, Greece

RECRUITING

Larissa, Greece Investigative Site 33003

Larissa, Greece, 41110, Greece

RECRUITING

Nyiregyhaza, Hungary Investigative Site 34004

Nyíregyháza, Hungary, 4400, Hungary

RECRUITING

Budapest Investigative Site 34001

Budapest, 1122, Hungary

RECRUITING

Budapest Investigative Site 34008

Budapest, 1204, Hungary

RECRUITING

Kaposvar Investigative Site 34005

Kaposvár, 7400, Hungary

RECRUITING

Orosháza Investigative Site 34002

Orosháza, 5900, Hungary

RECRUITING

Pecs Investigative Site 34006

Pécs, 7624, Hungary

RECRUITING

Szekszárd Investigative Site 34009

Szekszárd, 7100, Hungary

RECRUITING

Patna, Bihar Investigative Site 51001

Patna, Bihar, 800014, India

RECRUITING

Ahmedabad, Gujarat Investigative Site 51006

Ahmedabad, Gujarat, 380005, India

RECRUITING

Kochi, Kerala Investigative Site 51007

Kochi, Kerala, 682018, India

RECRUITING

Nagpur, Maharashtra Investigative Site 51009

Nagpur, Maharashtra, 440033, India

RECRUITING

New Delhi, Delhi Investigative Site 51004

New Delhi, National Capital Territory of Delhi, 110017, India

RECRUITING

New Delhi, Delhi Investigative Site 51011

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

New Delhi, Delhi Investigative Site 51005

New Delhi, New Delhi, 110060, India

RECRUITING

Mohali, Punjab Investigative Site 51012

Mohali, Punjab, 160062, India

RECRUITING

Chennai, Tamil Nadu Investigative site 51008

Chennai, Tamil Nadu, 600 006, India

RECRUITING

Bergamo, BG Investigative Site 35001

Bergamo, BG, 24127, Italy

RECRUITING

Loc. Germaneto, Catanzaro CZ Investigative Site 35003

Catanzaro, CZ, 88100, Italy

RECRUITING

Genova, GE Investigative Site 35005

Genova, GE, 16132, Italy

RECRUITING

Varese, Varese Investigative Site 35004

Varese, Varese, 21100, Italy

RECRUITING

Alytus, Lithuania Investigative Site 36005

Alytus, Lithuania, LT-62114, Lithuania

RECRUITING

Kaunas Investigative Site 36004

Kaunas, LT-50161, Lithuania

RECRUITING

Klaipeda Investigative Site 36002

Klaipėda, LT-92231, Lithuania

RECRUITING

Johor Bahru Investigative Site 52002

Johor Bahru, Johor, 80100, Malaysia

RECRUITING

Alor Setar, Kedah Investigative Site 52006

Alor Star, Kedah, 05460, Malaysia

RECRUITING

Kuala Lumpur, Wilayah Persekutuan Investigative Site 52007

Kuala Lumpur, Kuala Lumpur, 50400, Malaysia

RECRUITING

Kuantan, Pahang Investigative Site 52004

Kuantan, Pahang, 25100, Malaysia

RECRUITING

Kuantan, Pahang Investigative Site 52009

Kuantan, Pahang, 25200, Malaysia

RECRUITING

George Town, Penang Investigative Site 52003

George Town, Pulau Pinang, 10050, Malaysia

RECRUITING

Kajang, Selangor Investigative Site 52008

Kajang, Selangor, 43000, Malaysia

RECRUITING

Kuala, Terengganu Investigative Site 52005

Kuala, Terengganu, 20400, Malaysia

RECRUITING

Kuala Lumpur Investigative Site 52001

Kuala Lumpur, 59100, Malaysia

RECRUITING

Aguascalientes Investigative Site 23001

Aguascalientes, Aguascalientes, 20230, Mexico

RECRUITING

CULIACÁN, Flores Investigative Site 23002

Culiacán, Flores, 80230, Mexico

NOT YET RECRUITING

Guadalajara, Jalisco Investigative Site 23003

Guadalajara, Jalisco, 44280, Mexico

RECRUITING

Alcaldía Cuauhtémoc, Ciudad de México Investigative Site 23004

Cuauhtémoc, Mexico City, 06720, Mexico

RECRUITING

Ciudad de México Investigative Site 23011

Mexico City, Mexico City, 10700, Mexico

RECRUITING

Morelia, Michoacan Investigative Site 23007

Morelia, Michoacán, 58260, Mexico

NOT YET RECRUITING

Monterrey, Nuevo León Investigative Site 23005

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

San Nicolás de los Garza, Nuevo León Investigative Site 23008

San Nicolás, Nuevo León, 66465, Mexico

RECRUITING

Culiacan, Sinaloa Investigative Site 23006

Culiacán, Sinaloa, 80020, Mexico

RECRUITING

Ciudad de México Investigative Site 23009

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

Xalapa, Veracruz Investigative Site 23012

Xalapa, Veracruz, 91193, Mexico

RECRUITING

Ciudad de México Investigative Site 23010

Mexico City, C.P. 14080, Mexico

RECRUITING

Lima, Lima Investigative Site 24011

Lima, Lima Province, 15046, Peru

RECRUITING

Lima Investigative Site 24009

Lima, 15036, Peru

RECRUITING

Lima Investigative Site 24010

Lima, 15036, Peru

RECRUITING

Lima Investigative Site 24003

Lima, 15072, Peru

RECRUITING

Lima Investigative Site 24008

Lima, 15076, Peru

RECRUITING

Lima Investigative Site 24005

Lima, 15082, Peru

RECRUITING

Lima Investigative Site 24004

Lima, 15102, Peru

RECRUITING

Lodz Investigative Site 37001

Lodz, 90-549, Poland

RECRUITING

Łódź Investigative Site 37003

Lodz, 92213, Poland

RECRUITING

Lublin Investigative Site 37006

Lublin, 20-011, Poland

RECRUITING

Oświęcim Investigative Site 37002

Oświęcim, 32-600, Poland

RECRUITING

Wonju-si, Gangwon-do Investigative Site 53002

Wŏnju, Gangwon-do, 26426, South Korea

RECRUITING

Guro-gu, Seoul Investigative Site 53007

Seoul, Guro-gu, 08308, South Korea

RECRUITING

Jung-gu, Incheon Investigative Site 53009

Incheon, Incheon, 22332, South Korea

RECRUITING

Daejeon, Jung-gu Investigative Site 53004

Daejeon, Jung-gu, 35015, South Korea

RECRUITING

Seoul, Seongbuk-gu Investigative Site, 53006

Seoul, Seongbuk-gu, 02841, South Korea

RECRUITING

Seodaemun-gu, Seoul Investigative Site 53001

Seoul, Seoul, 03722, South Korea

RECRUITING

Badalona, Barcelona Investigative Site 38005

Badalona, Barcelona, 08916, Spain

RECRUITING

A Coruña, Galicia Investigative Site 38004

A Coruña, Galicia, 15006, Spain

RECRUITING

Santiago De Compostela, Galicia Investigative Site 38008

Santiago de Compostela, Galicia, 15706, Spain

RECRUITING

Barcelona, Spain Investigative Site 38010

Barcelona, Spain, 08907, Spain

RECRUITING

Manises, Valencia Investigative Site 38009

Manises, Valencia, 46940, Spain

RECRUITING

Girona Investigative Site 38017

Girona, 17007, Spain

RECRUITING

Madrid Investigative Site 38002

Madrid, 28034, Spain

RECRUITING

Madrid Investigative Site 38011

Madrid, 28046, Spain

RECRUITING

Madrid Investigative Site 38006

Madrid, 28222, Spain

RECRUITING

Murcia Investigative Site 38003

Murcia, 30120, Spain

RECRUITING

Valencia Investigative Site 38001

Valencia, 46010, Spain

RECRUITING

Valencia Investigative Site 38007

Valencia, 46026, Spain

RECRUITING

Kandy, Central Province Investigative Site 54001

Kandy, Central Province, 2000, Sri Lanka

RECRUITING

Polonnaruwa, North Central Province Investigative Site 54012

Polonnaruwa, North Central Province, 51000, Sri Lanka

RECRUITING

Jaffna, Northern Province Investigative Site 54010

Jaffna, Northern Province, 40000, Sri Lanka

RECRUITING

Colombo 02, Western Province Investigative Site 54009

Colombo, Western Province, 00200, Sri Lanka

RECRUITING

Colombo 10, Western Province Investigative Site 54004

Colombo, Western Province, 01000, Sri Lanka

RECRUITING

Colombo 10, Western Province Investigative Site 54006

Colombo, Western Province, 01000, Sri Lanka

RECRUITING

Colombo 10, Western Province

Colombo, Western Province, 01000, Sri Lanka

RECRUITING

Boralesgamuwa, Western Province Investigative Site 54011

Colombo, Western Province, 10290, Sri Lanka

RECRUITING

Dehiwala, Western Province Investigative Site 54007

Dehiwala, Western Province, 10350, Sri Lanka

RECRUITING

Negombo, Western Province Investigative Site 54002

Negombo, Western Province, 11500, Sri Lanka

RECRUITING

Nugegoda, Western Province Investigative Site 54003

Nugegoda, Western Province, 10250, Sri Lanka

RECRUITING

Ragama, Western Province Investigative Site 54008

Ragama, Western Province, 11010, Sri Lanka

RECRUITING

Kaohsiung City, Taiwan, Investigative Site 55002

Kaohsiung City, Taiwan, 807, Taiwan

RECRUITING

Taipei, Taiwan Investigative Site 55008

Taipei, Taiwan, 106, Taiwan

RECRUITING

Taipei City, Taiwan Investigative Site 55009

Taipei, Taiwan, 112401, Taiwan

RECRUITING

Brighton, East Sussex Investigative Site 39021

Brighton, East Sussex, BN2 1ES, United Kingdom

RECRUITING

Southampton, Hampshire Investigative Site 39006

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Ashford, Kent Investigative Site 39020

Ashford, Kent, TN02 0LZ, United Kingdom

RECRUITING

Liverpool, Liverpool Investigative Site 39024

Liverpool, Liverpool, L9 7AL, United Kingdom

RECRUITING

Chester, North West England Investigative Site 39022

Chester, North West England, CH2 1UL, United Kingdom

RECRUITING

Ashington, Northumberland Investigative Site 39017

Ashington, Northumberland, NE63 9JJ, United Kingdom

RECRUITING

Dudley, West Midlands Investigative Site 39018

Dudley, West Midlands, DY1 2HQ, United Kingdom

RECRUITING

Cardiff, Investigative Site 39015

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Glasgow Investigative Site 39001

Glasgow, G4 0SF, United Kingdom

RECRUITING

London, Investigative Site 39016

London, SE5 9RS, United Kingdom

RECRUITING

London, Investigative Site 39002

London, SW17 0QT, United Kingdom

RECRUITING

Manchester Investigative Site 39003

Manchester, M13 9WL, United Kingdom

RECRUITING

Plymouth, Investigative Site 39014

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Portadown, Investigative Site 39005

Portadown, BT63 5QQ, United Kingdom

RECRUITING

Swindon Investigative Site 39004

Swindon, SN3 6BB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

finerenone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Marc Bonaca

CONTACT

303-860-9900; info@cpcmed.org

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: July 31, 2023
• First Posted: August 23, 2023
• Study Start: January 17, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (77); HU (7); PL (4); GB (15); SR (12); IN (9); LI (3); ES (12); CR (9); TW (3); KR (6); IT (4); BR (50); AU (5); ME (12); PE (7); AR (20); MY (9); GR (7); CZ (5); DE (6); CA (17)