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RECRUITING

NCT06008197

PHASE3

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

Sponsor: Colorado Prevention Center

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5200

Start Date

2024-01-17

Completion Date

2027-12

Last Updated

2026-05-06

Healthy Volunteers

Conditions

Heart Failure Acute Heart Failure

Interventions

DRUG

Finerenone

Oral finerenone

DRUG

Placebo

Matching oral placebo

Locations (299)

Birmingham, AL Investigative Site 10012

Birmingham, Alabama, United States

Fairhope, AL Investigative Site 10004

Fairhope, Alabama, United States

Huntsville, AL Investigative Site 10026

Huntsville, Alabama, United States

Glendale, AZ Investigative Site 10096

Glendale, Arizona, United States

Scottsdale, AZ Investigative Site 10003

Scottsdale, 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

Sacramento, CA Investigative Site 10024

Sacramento, California, United States

San Francisco, CA Investigative Site 10023

San Francisco, California, United States

Tarzana, CA Investigative Site 10409

Tarzana, California, United States

Van Nuys, CA Investigative Site 10109

Van Nuys, California, United States

West Hills, CA Investigative Site 10013

West Hills, California, United States

Aurora, CO Investigative Site 10001

Aurora, Colorado, United States

Denver, CO Investigative Site 10005

Denver, Colorado, United States

Bradenton, FL Investigative Site 10125

Bradenton, Florida, United States

Brooksville, FL Investigative Site 10077

Brooksville, Florida, United States

Fort Lauderdale, FL Investigative Site 10114

Fort Lauderdale, Florida, United States

Fort Myers, FL Investigative Site 10076

Fort Myers, Florida, United States

Hialeah, FL Investigative Site 10104

Hialeah, Florida, United States

Jacksonville, FL Investigative Site 10028

Jacksonville, Florida, United States

Miami, FL Investigative Site 10105

Miami, Florida, United States

Miami, FL Investigative Site 10040

Miami, Florida, United States

Miramar, FL Investigative Site 10113

Miramar, Florida, United States

Atlanta, GA Investigative Site 10022

Atlanta, Georgia, United States

Duluth, GA Investigative Site 10083

Duluth, Georgia, United States

Boise, Idaho Investigative Site 10073

Boise, Idaho, United States

Chicago, IL Investigative Site 10062

Chicago, Illinois, United States

Glenview, IL Investigative Site 10021

Glenview, Illinois, United States

Naperville, IL Investigative Site 10025

Naperville, Illinois, United States

Peoria, IL Investigative Site 10019

Peoria, Illinois, United States

Peoria, IL Investigative Site 10010

Peoria, 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

Kansas City, KS Investigative Site 10060

Kansas City, Kansas, United States

Lexington, KY Investigative Site 10080

Lexington, Kentucky, 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

Baton Rouge, LA Investigative Site 10030

Baton Rouge, Louisiana, United States

Hammond, LA Investigative Site 10106

Hammond, Louisiana, United States

West Monroe, LA Investigative Site 10090

West Monroe, Louisiana, United States

Baltimore, MD Investigative Site 10101

Baltimore, Maryland, United States

Bowie, MD Investigative Site 10020

Bowie, Maryland, United States

Boston, MA Investigative Stie 10087

Boston, Massachusetts, United States

Minneapolis, MN Investigative Site 10091

Minneapolis, Minnesota, United States

Minneapolis, MN Investigative Site 10035

Minneapolis, Minnesota, United States

Tupelo, MS Investigative Site 10100

Tupelo, Mississippi, United States

Kansas City, MO Investigative Site 10002

Kansas City, Missouri, United States

Omaha, NE Investigative Site 10018

Omaha, Nebraska, United States

Camden, NJ Investigative Site 10033

Camden, New Jersey, United States

Roslyn, NY Investigative Site 10058

Roslyn, New York, United States

Stony Brook, NY Investigative Site 10017

Stony Brook, New York, United States

Akron, OH Investigative Site 10081

Akron, Ohio, 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

Philadelphia, PA Investigative Site 10068

Philadelphia, Pennsylvania, United States

Pittsburg, PA Investigative Site 1044

Pittsburgh, Pennsylvania, United States

Providence, RI Investigative Site 10050

Providence, Rhode Island, United States

Charleston, SC Investigative Site 10056

Charleston, South Carolina, United States

Germantown, TN Investigative Site 10063

Germantown, Tennessee, United States

Memphis, TN Investigative Site 10059

Memphis, Tennessee, United States

Nashville, TN Investigative Site 10071

Nashville, Tennessee, United States

Amarillo, TX Investigative Site 10045

Amarillo, Texas, United States

Austin, TX Investigative Site 10015

Austin, Texas, United States

Dallas, TX Investigative Site 10042

Dallas, Texas, United States

Houston, TX Investigative Site 10085

Houston, Texas, United States

Plano, TX Investigative Site 10014

Plano, Texas, United States

Burlington, VT Investigative Site 10053

Burlington, Vermont, United States

Norfolk, VA Investigative Site 10009

Norfolk, Virginia, United States

Richmond, VA Investigative Site 10069

Richmond, Virginia, United States

Richmond, VA Investigative Site 10067

Richmond, Virginia, United States

Salem, VA Investigative Site 10048

Salem, Virginia, United States

Milwaukee, WI Investigative Site 10061

Milwaukee, Wisconsin, United States

Buenos Aires Investigative Site 20017

Buenos Aires, Buenos Aires, Argentina

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 Investigative Site 20012

Córdoba, Córdoba Province, Argentina

Córdoba Investigative Site 20013

Córdoba, Córdoba Province, Argentina

Córdoba Investigative Site 20016

Córdoba, Córdoba Province, Argentina

Córdoba, Córdoba Investigative Site 20014

Córdoba, Córdoba Province, Argentina

Salta Investigative Site 20006

Salta, Salta Province, Argentina

San Juan, San Juan Investigative Site 20021

San Juan, San Juan Province, Argentina

San Juan, San Juan Investigative Site 20020

San Juan, San Juan Province, Argentina

Rafaela, Santa Fe Investigative Site 20026

Rafaela, Santa Fe Province, Argentina

Rosario, Santa Fe Investigative Site 20003

Rosario, Santa Fe Province, Argentina

Rosario, Santa Fe Investigative Site 20022

Rosario, Santa Fe Province, Argentina

Rosario, Santa Fe Investigative Site 20027

Rosario, Santa Fe Province, Argentina

Rosario, Santa Fe Investigative Site 20019

Rosario, Santa Fe Province, Argentina

Buenos Aires City Investigative Site 20002

Buenos Aires, Argentina

Córdoba Investigative Site 20005

Córdoba, Argentina

Blacktown, NSW Investigative Site 50006

Blacktown, New South Wales, Australia

Milton, Queensland Investigative Site 50001

Milton, Queensland, Australia

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

Rio Branco, Acre Investigative Site 21063

Rio Branco, Acre, Brazil

Arapiraca, Alagoas Investigative Site 21064

Arapiraca, Alagoas, Brazil

Fortaleza, Ceará Investigative Site 21055

Fortaleza, Ceará I, Brazil

Centro Linhares, Espirito Santo Investigative Site 21017

Linhares, Espírito Santo, Brazil

Vila Velha, Espírito Santo Investigative Site 21059

Vila Velha, Espírito Santo, Brazil

Salvador, Bahia Investigative Site 21032

Salvador, Estado de Bahia, Brazil

Brasília, Distrito Federal Investigative Site 21028

Brasília, Federal District, Brazil

Aparecida de Goiânia, Goiás Investigative Site 21053

Aparecida de Goiânia, Goiás, 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 21020

Belo Horizonte, Minas Gerais, Brazil

Belo Horizonte, Minas Gerais Investigative Site 21051

Belo Horizonte, Minas Gerais, Brazil

Poços de Caldas, Minas Gerais Investigative Site 21009

Poços de Caldas, Minas Gerais, Brazil

Curitiba, Parana Investigative Site 21029

Curitiba, Paraná, Brazil

Curitiba, Paraná Investigative Site 21056

Curitiba, Paraná, Brazil

Curitiba, Paraná Investigative Site 21038

Curitiba, Paraná, Brazil

Londrina, Paraná Investigative Site 21047

Londrina, Paraná, Brazil

Recife, Pernambuco Investigative Site 21061

Recife, Pernambuco, 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

Natal, Rio Grande do Norte Investigative Site 21024

Natal, Rio Grande do Norte, 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

Porto Alegre, RS Investigative Site 21019

Porto Alegre, Rio Grande do Sul, Brazil

Caxias do Sul, Rio Grande do Sull Investigative Site 21008

Caxias do Sul, Rio Grande Do Sull, 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

Bragança Paulista, São Paulo Investigative Site 21004

Bragança Paulista, São Paulo, Brazil

Itaquera, São Paulo Investigative Site 21005

Itaquera, São Paulo, Brazil

Osasco, São Paulo Investigative Site 21010

Osasco, São Paulo, Brazil

Presidente Prudente, São Paulo Investigative Site 21011

Presidente Prudente, São Paulo, Brazil

Santo André, Sao Paulo Investigative Site 21043

Santo André, São Paulo, Brazil

São Carlos, São Paulo Investigative Site 21075

São Carlos, 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 Investigative Site 21054

São Paulo, São Paulo, Brazil

São Paulo, São Paulo Investigative Site 21062

São Paulo, São Paulo, Brazil

São Paulo Investigative Site 21037

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

Votuporanga, São Paulo Investigative Site 21031

Votuporanga, São Paulo, Brazil

São Paulo Investigative Site 21066

São Paulo, Brazil

Calgary, AB Investigative Site 11009

Calgary, Alberta, Canada

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

Winnipeg, MB Investigative Site 11006

Winnipeg, Manitoba, Canada

Cambridge, ON Investigative Site 11003

Cambridge, Ontario, Canada

Sudbury, ON Investigative Site 11016

Greater Sudbury, Ontario, Canada

London, ON Investigative Site 11010

London, 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

Toronto, ON Investigative Site 11001

Toronto, Ontario, Canada

Sherbrooke, QC Investigative Site 11005

Sherbrooke, Quebec, Canada

Regina, SK Investigative Site 11022

Regina, Saskatchewan, Canada

Zagreb Investigative Site 30007

Zagreb, City of Zagreb, Croatia

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

Dresden Investigative Site 32003

Dresden, Germany

Giessen Investigative Site 32005

Giessen, Germany

Regensburg Investigative Site 32002

Regensburg, Germany

Athens, Attica Investigative Site 33001

Athens, Attica, Greece

Athens, Attica Investigative Site 33004

Athens, Attica, Greece

Athens, Attica Investigative Site 33005

Athens, Attica, Greece

Chaidari, Attica Investigative Site 33006

Chaïdári, Attica, Greece

Thessaloniki, Central Macedonia Investigative Site 33002

Thessaloniki, Central Macedonia, Greece

Athens, Investigative Site 33007

Athens, Greece, Greece

Larissa, Greece Investigative Site 33003

Larissa, Greece, Greece

Nyiregyhaza, Hungary Investigative Site 34004

Nyíregyháza, Hungary, Hungary

Budapest Investigative Site 34001

Budapest, Hungary

Budapest Investigative Site 34008

Budapest, Hungary

Kaposvar Investigative Site 34005

Kaposvár, Hungary

Orosháza Investigative Site 34002

Orosháza, Hungary

Pecs Investigative Site 34006

Pécs, Hungary

Szekszárd Investigative Site 34009

Szekszárd, Hungary

Patna, Bihar Investigative Site 51001

Patna, Bihar, India

Ahmedabad, Gujarat Investigative Site 51006

Ahmedabad, Gujarat, India

Kochi, Kerala Investigative Site 51007

Kochi, Kerala, India

Nagpur, Maharashtra Investigative Site 51009

Nagpur, Maharashtra, India

New Delhi, Delhi Investigative Site 51004

New Delhi, National Capital Territory of Delhi, India

New Delhi, Delhi Investigative Site 51011

New Delhi, National Capital Territory of Delhi, India

New Delhi, Delhi Investigative Site 51005

New Delhi, New Delhi, India

Mohali, Punjab Investigative Site 51012

Mohali, Punjab, India

Chennai, Tamil Nadu Investigative site 51008

Chennai, Tamil Nadu, India

Bergamo, BG Investigative Site 35001

Bergamo, BG, Italy

Loc. Germaneto, Catanzaro CZ Investigative Site 35003

Catanzaro, CZ, Italy

Genova, GE Investigative Site 35005

Genova, GE, Italy

Varese, Varese Investigative Site 35004

Varese, Varese, Italy

Alytus, Lithuania Investigative Site 36005

Alytus, Lithuania, Lithuania

Kaunas Investigative Site 36004

Kaunas, Lithuania

Klaipeda Investigative Site 36002

Klaipėda, Lithuania

Johor Bahru Investigative Site 52002

Johor Bahru, Johor, Malaysia

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

Kuantan, Pahang Investigative Site 52009

Kuantan, Pahang, Malaysia

George Town, Penang Investigative Site 52003

George Town, Pulau Pinang, Malaysia

Kajang, Selangor Investigative Site 52008

Kajang, Selangor, Malaysia

Kuala, Terengganu Investigative Site 52005

Kuala, Terengganu, Malaysia

Kuala Lumpur Investigative Site 52001

Kuala Lumpur, Malaysia

Aguascalientes Investigative Site 23001

Aguascalientes, Aguascalientes, Mexico

CULIACÁN, Flores Investigative Site 23002

Culiacán, Flores, Mexico

Guadalajara, Jalisco Investigative Site 23003

Guadalajara, Jalisco, Mexico

Alcaldía Cuauhtémoc, Ciudad de México Investigative Site 23004

Cuauhtémoc, Mexico City, 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

Xalapa, Veracruz Investigative Site 23012

Xalapa, Veracruz, Mexico

Ciudad de México Investigative Site 23010

Mexico City, Mexico

Lima, Lima Investigative Site 24011

Lima, Lima Province, Peru

Lima Investigative Site 24009

Lima, Peru

Lima Investigative Site 24010

Lima, Peru

Lima Investigative Site 24003

Lima, Peru

Lima Investigative Site 24008

Lima, Peru

Lima Investigative Site 24005

Lima, Peru

Lima Investigative Site 24004

Lima, Peru

Lodz Investigative Site 37001

Lodz, Poland

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

Jung-gu, Incheon Investigative Site 53009

Incheon, Incheon, 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

Badalona, Barcelona Investigative Site 38005

Badalona, Barcelona, Spain

A Coruña, Galicia Investigative Site 38004

A Coruña, Galicia, Spain

Santiago De Compostela, Galicia Investigative Site 38008

Santiago de Compostela, Galicia, Spain

Barcelona, Spain Investigative Site 38010

Barcelona, Spain, Spain

Manises, Valencia Investigative Site 38009

Manises, Valencia, Spain

Girona Investigative Site 38017

Girona, Spain

Madrid Investigative Site 38002

Madrid, Spain

Madrid Investigative Site 38011

Madrid, Spain

Madrid Investigative Site 38006

Madrid, Spain

Murcia Investigative Site 38003

Murcia, Spain

Valencia Investigative Site 38001

Valencia, Spain

Valencia Investigative Site 38007

Valencia, Spain

Kandy, Central Province Investigative Site 54001

Kandy, Central Province, Sri Lanka

Polonnaruwa, North Central Province Investigative Site 54012

Polonnaruwa, North Central Province, Sri Lanka

Jaffna, Northern Province Investigative Site 54010

Jaffna, Northern Province, Sri Lanka

Colombo 02, Western Province Investigative Site 54009