RecruitingPhase 3NCT06008197

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

Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction Greater Than or Equal to 40% Hospitalized Due to an Episode of Acute Decompensated Heart Failure (REDEFINE-HF)

Sponsor

Colorado Prevention Center

Enrollment

5,200 participants

Start Date

Jan 17, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Acute Heart Failure

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether finerenone, a drug that blocks a hormone linked to heart and kidney damage, can reduce hospitalizations and deaths in people with heart failure whose heart pumps at a preserved or mildly reduced level. **You may be eligible if...** - You are 18 or older and currently hospitalized or recently discharged for heart failure - Your heart's ejection fraction is 40% or higher - You have elevated heart failure biomarkers (BNP or NTproBNP) in your blood **You may NOT be eligible if...** - You are already taking a mineralocorticoid receptor antagonist (like spironolactone) - You have very low kidney function (eGFR below 25) or high potassium - You recently had a heart attack, valve procedure, or cardiac device implanted - You have certain types of heart disease (e.g., hypertrophic cardiomyopathy, congenital heart disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFinerenone

Oral finerenone

DRUGPlacebo

Matching oral placebo

Locations(156)

Glendale, AZ Investigative Site 10096

Glendale, Arizona, United States

Chula Vista, CA Investigative Site 10111

Chula Vista, California, United States

Huntington Beach, CA Investigative Site 10031

Huntington Beach, California, United States

Los Angeles, CA Investigative Site 10089

Los Angeles, California, United States

Tarzana, CA Investigative Site 10409

Tarzana, California, United States

Van Nuys, CA Investigative Site 10109

Van Nuys, California, United States

Bradenton, FL Investigative Site 10125

Bradenton, Florida, United States

Brooksville, FL Investigative Site 10077

Brooksville, Florida, United States

Miramar, FL Investigative Site 10113

Miramar, Florida, United States

Boise, Idaho Investigative Site 10073

Boise, Idaho, United States

Chicago, IL Investigative Site 10062

Chicago, Illinois, United States

Indianapolis, IN Investigative Site 10074

Indianapolis, Indiana, United States

Indianapolis, IN Investigative Site 10008

Indianapolis, Indiana, United States

Merrillville, IN Investigative Site 10064

Merrillville, Indiana, United States

Lexington, KY Investigative Site 10118

Lexington, Kentucky, United States

Louisville, KY Investigative Site 10006

Louisville, Kentucky, United States

Louisville, KY Investigative Site 10086

Louisville, Kentucky, United States

Paducah, KY Investigative Site 10079

Paducah, Kentucky, United States

West Monroe, LA Investigative Site 10090

West Monroe, Louisiana, United States

Boston, MA Investigative Stie 10087

Boston, Massachusetts, United States

Minneapolis, MN Investigative Site 10091

Minneapolis, Minnesota, United States

Tupelo, MS Investigative Site 10100

Tupelo, Mississippi, United States

Stony Brook, NY Investigative Site 10017

Stony Brook, New York, United States

Centerville, OH Investigative Site 10119

Centerville, Ohio, United States

Cincinnati, OH Investigative Site 10088

Cincinnati, Ohio, United States

Bartlesville, OK Investigative Site 10095

Bartlesville, Oklahoma, United States

Charleston, SC Investigative Site 10056

Charleston, South Carolina, United States

Memphis, TN Investigative Site 10059

Memphis, Tennessee, United States

Burlington, VT Investigative Site 10053

Burlington, Vermont, United States

Salem, VA Investigative Site 10048

Salem, Virginia, United States

Milwaukee, WI Investigative Site 10061

Milwaukee, Wisconsin, United States

Buenos Aires Investigative Site 20009

Buenos Aires, Buenos Aires, Argentina

La Plata, Buenos Aires Investigative Site 20023

La Plata, Buenos Aires, Argentina

Lanús, Buenos Aires Investigative Site 20024

Lanus, Buenos Aires, Argentina

Corrientes Investigative Site 20001

Corrientes, Corrientes Province, Argentina

Córdoba Investigative Site 20025

Córdoba, Córdoba Province, Argentina

Córdoba, Córdoba Investigative Site 20014

Córdoba, Córdoba Province, Argentina

Rafaela, Santa Fe Investigative Site 20026

Rafaela, Santa Fe Province, Argentina

Rosario, Santa Fe Investigative Site 20027

Rosario, Santa Fe Province, Argentina

Elizabeth Vale, South Australia Investigative Site 50008

Elizabeth Vale, South Australia, Australia

Melbourne, VIC Investigative Site 50005

Melbourne, Victoria, Australia

Mulgrave, Victoria Investigative Site 50004

Mulgrave, Victoria, Australia

Arapiraca, Alagoas Investigative Site 21064

Arapiraca, Alagoas, Brazil

Fortaleza, Ceará Investigative Site 21055

Fortaleza, Ceará I, Brazil

Vila Velha, Espírito Santo Investigative Site 21059

Vila Velha, Espírito Santo, Brazil

Salvador, Bahia Investigative Site 21032

Salvador, Estado de Bahia, Brazil

Goiânia, Goiás Investigative Site 21003

Goiânia, Goiás, Brazil

Belo Horizonte, Minais Gerais Investigative Site 21013

Belo Horizonte, Minais Gerais, Brazil

Belo Horizonte, Minas Gerais Investigative Site 21051

Belo Horizonte, Minas Gerais, Brazil

Curitiba, Paraná Investigative Site 21056

Curitiba, Paraná, Brazil

Curitiba, Paraná Investigative Site 21038

Curitiba, Paraná, Brazil

Teresina, Piaui Investigative Site 21050

Teresina, Piauí, Brazil

Recife, Recife Investigative Site 21001

Recife, Recife, Brazil

Rio De Janeiro, Rio De Janeiro Investigative Site 21016

Rio de Janeiro, Rio de Janeiro, Brazil

Rio de Janeiro Investigative Site 21034

Rio de Janeiro, Rio de Janeiro, Brazil

Passo Fundo, Rio Grande do Sul Investigative Site 21042

Passo Fundo, Rio Grande do Sul, Brazil

Porto Alegre, RS Investigative Site 21060

Porto Alegre, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul Investigative Site 21025

Porto Alegre, Rio Grande do Sul, Brazil

JOINVILLE, Santa Catarina Investigative Site 21007

Joinville, Santa Catarina, Brazil

São José, Santa Catarina Investigative Site 21002

São José, Santa Catarina, Brazil

Aracaju, Sergipe Investigative Site 21058

Aracaju, Sergipe, Brazil

Aracaju, Sergipe Investigative Site 21015

Aracaju, Sergipe, Brazil

Atibaia, São Paulo Investigative Site 21057

Atibaia, São Paulo, Brazil

Itaquera, São Paulo Investigative Site 21005

Itaquera, São Paulo, Brazil

Osasco, São Paulo Investigative Site 21010

Osasco, São Paulo, Brazil

Santo André, Sao Paulo Investigative Site 21043

Santo André, São Paulo, Brazil

São José Dos Campos, Sao Paulo Investigative Site 21012

São José dos Campos, São Paulo, Brazil

São Paulo Investigative Site 21074

São Paulo, São Paulo, Brazil

São Paulo, São Paulo Investigative Site 21062

São Paulo, São Paulo, Brazil

São Paulo, São Paulo Investigative Site 21048

São Paulo, São Paulo, Brazil

São Paulo, São Paulo Investigative Site 21041

São Paulo, São Paulo, Brazil

São Paulo, São Paulo Investigative Site 21035

São Paulo, São Paulo, Brazil

São Paulo, São Paulo Investigative Site 21049

São Paulo, São Paulo, Brazil

São Paulo Investigative Site 21066

São Paulo, Brazil

Edmonton, AB Investigative Site 11018

Edmonton, Alberta, Canada

Edmonton, Alberta Investigative Site 11011

Edmonton, Alberta, Canada

Kamloops, BC Investigative Site 11021

Kamloops, British Columbia, Canada

North Vancouver, BC Investigative Site11020

North Vancouver, British Columbia, Canada

Surrey, British Columbia Investigative Site 11012

Surrey, British Columbia, Canada

Vancouver, BC Investigative Site 11017

Vancouver, British Columbia, Canada

Cambridge, ON Investigative Site 11003

Cambridge, Ontario, Canada

Sudbury, ON Investigative Site 11016

Greater Sudbury, Ontario, Canada

North York, Ontario Investigative Site 11007

North York, Ontario, Canada

Toronto, Ontario Investigative Site 11008

Toronto, Ontario, Canada

Toronto, ON Investigative Site 11019

Toronto, Ontario, Canada

Regina, SK Investigative Site 11022

Regina, Saskatchewan, Canada

Zagreb, Grad Zagreb Investigative Site 30005

Zagreb, Croatia, Croatia

Rijeka Investigative Site 30009

Rijeka, Primorje-Gorski Kotar County, Croatia

Krapinske Toplice Investigative Site 30004

Krapinske Toplice, Croatia

Osijek Investigative Site 30008

Osijek, Croatia

Varazdin Investigative Site 30002

Varaždin, Croatia

Zagreb Investigative Site 30001

Zagreb, Croatia

Zagreb Investigative Site 30003

Zagreb, Croatia

Zagreb Investigative Site 30006

Zagreb, Croatia

Chlumec nad Cidlinou, Czech Republic Investigative Site 31005

Chlumec nad Cidlinou, Czech Republic, Czechia

Plzeň, Czech Republic Investigative Site 31006

Pilsen, Czech Republic, Czechia

Brno-Zidenice Investigative Site 31011

Brno, Zidenice, Czechia

Brno Investigative Site 31002

Brno, Czechia

Praha 4 Investigative Site 31003

Prague, Czechia

Lübeck Investigative Site 32006

Lübeck, Lübeck, Germany

Berlin, Berlin Investigative Site 32001

Berlin, State of Berlin, Germany

Jena Investigative Site 32004

Jena, Thuringia, Germany

Giessen Investigative Site 32005

Giessen, Germany

Athens, Investigative Site 33007

Athens, Greece, Greece

Kaposvar Investigative Site 34005

Kaposvár, Hungary

Orosháza Investigative Site 34002

Orosháza, Hungary

Pecs Investigative Site 34006

Pécs, Hungary

Szekszárd Investigative Site 34009

Szekszárd, Hungary

Ahmedabad, Gujarat Investigative Site 51006

Ahmedabad, Gujarat, India

Chennai, Tamil Nadu Investigative site 51008

Chennai, Tamil Nadu, India

Varese, Varese Investigative Site 35004

Varese, Varese, Italy

Alytus, Lithuania Investigative Site 36005

Alytus, Lithuania, Lithuania

Alor Setar, Kedah Investigative Site 52006

Alor Star, Kedah, Malaysia

Kuala Lumpur, Wilayah Persekutuan Investigative Site 52007

Kuala Lumpur, Kuala Lumpur, Malaysia

Kuantan, Pahang Investigative Site 52004

Kuantan, Pahang, Malaysia

George Town, Penang Investigative Site 52003

George Town, Pulau Pinang, Malaysia

Kajang, Selangor Investigative Site 52008

Kajang, Selangor, Malaysia

CULIACÁN, Flores Investigative Site 23002

Culiacán, Flores, Mexico

Ciudad de México Investigative Site 23011

Mexico City, Mexico City, Mexico

Morelia, Michoacan Investigative Site 23007

Morelia, Michoacán, Mexico

Monterrey, Nuevo León Investigative Site 23005

Monterrey, Nuevo León, Mexico

San Nicolás de los Garza, Nuevo León Investigative Site 23008

San Nicolás, Nuevo León, Mexico

Culiacan, Sinaloa Investigative Site 23006

Culiacán, Sinaloa, Mexico

Ciudad de México Investigative Site 23009

Mexico City, Tlalpan, Mexico

Ciudad de México Investigative Site 23010

Mexico City, Mexico

Lima, Lima Investigative Site 24011

Lima, Lima Province, Peru

Łódź Investigative Site 37003

Lodz, Poland

Lublin Investigative Site 37006

Lublin, Poland

Oświęcim Investigative Site 37002

Oświęcim, Poland

Wonju-si, Gangwon-do Investigative Site 53002

Wŏnju, Gangwon-do, South Korea

Guro-gu, Seoul Investigative Site 53007

Seoul, Guro-gu, South Korea

Daejeon, Jung-gu Investigative Site 53004

Daejeon, Jung-gu, South Korea

Seoul, Seongbuk-gu Investigative Site, 53006

Seoul, Seongbuk-gu, South Korea

Seodaemun-gu, Seoul Investigative Site 53001

Seoul, Seoul, South Korea

Santiago De Compostela, Galicia Investigative Site 38008

Santiago de Compostela, Galicia, Spain

Barcelona, Spain Investigative Site 38010

Barcelona, Spain, Spain

Madrid Investigative Site 38011

Madrid, Spain

Madrid Investigative Site 38006

Madrid, Spain

Kaohsiung City, Taiwan, Investigative Site 55002

Kaohsiung City, Taiwan, Taiwan

Taipei, Taiwan Investigative Site 55008

Taipei, Taiwan, Taiwan

Taipei City, Taiwan Investigative Site 55009

Taipei, Taiwan, Taiwan

Brighton, East Sussex Investigative Site 39021

Brighton, East Sussex, United Kingdom

Southampton, Hampshire Investigative Site 39006

Southampton, Hampshire, United Kingdom

Ashford, Kent Investigative Site 39020

Ashford, Kent, United Kingdom

Liverpool, Liverpool Investigative Site 39024

Liverpool, Liverpool, United Kingdom

Chester, North West England Investigative Site 39022

Chester, North West England, United Kingdom

Ashington, Northumberland Investigative Site 39017

Ashington, Northumberland, United Kingdom

Dudley, West Midlands Investigative Site 39018

Dudley, West Midlands, United Kingdom

Cardiff, Investigative Site 39015

Cardiff, United Kingdom

Glasgow Investigative Site 39001

Glasgow, United Kingdom

London, Investigative Site 39016

London, United Kingdom

London, Investigative Site 39002

London, United Kingdom

Manchester Investigative Site 39003

Manchester, United Kingdom

Plymouth, Investigative Site 39014

Plymouth, United Kingdom

Portadown, Investigative Site 39005

Portadown, United Kingdom

Swindon Investigative Site 39004

Swindon, United Kingdom

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NCT06008197

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