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RECRUITING
NCT06033950
PHASE3

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

Sponsor: Colorado Prevention Center

View on ClinicalTrials.gov

Summary

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2600

Start Date

2024-08-20

Completion Date

2028-01

Last Updated

2026-07-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

Finerenone

Oral finerenone.

DRUG

Placebo

Matching oral placebo.

Locations (176)

FIN-10004 Fairhope, AL Investigational Site

Fairhope, Alabama, United States

Phoenix, AZ Investigative Site FIN-10115

Phoenix, Arizona, United States

FIN-10401, Yuma, AZ

Yuma, Arizona, United States

Chula Vista, CA Investigative Site FIN-10419

Chula Vista, California, United States

Chula Vista, CA Investigative Site FIN-10111

Chula Vista, California, United States

FIN-10407, Northridge, CA

Northridge, California, United States

FIN-10412, Orange, CA

Orange, California, United States

FIN-10070, Pamona, CA

Pomona, California, United States

FIN-10024, Sacramento, CA

Sacramento, California, United States

FIN-10406, San Diego, CA

San Diego, California, United States

San Diego, CA Investigative Site FIN-10420

San Diego, California, United States

FIN-10075 San Diego, CA Investigational Site

San Diego, California, United States

San Francisco, CA Investigative Site FIN-10023

San Francisco, California, United States

FIN-10423, Sherman Oaks, CA

Sherman Oaks, California, United States

FON-10409, Tarzana, CA

Tarzana, California, United States

FIN-10109, Van Nuys, CA

Van Nuys, California, United States

FIN-10408, West Covina, CA

West Covina, California, United States

FIN-10013, West Hills, CA

West Hills, California, United States

FIN-10110, Aurora, CO

Aurora, Colorado, United States

FIN-10001, Aurora, CO

Aurora, Colorado, United States

Bradenton, FL Investigative Site FIN-10125

Bradenton, Florida, United States

FIN-10104, Hialeah, FL

Hialeah, Florida, United States

FIN-10028, Jacksonville, FL

Jacksonville, Florida, United States

FIN-10105, Miami, FL

Miami, Florida, United States

FIN-10113, Miramar, FL

Miramar, Florida, United States

FIN-10019, Peoria, IL

Peoria, Illinois, United States

FIN-10064, Merrillville, IN

Merrillville, Indiana, United States

Cynthiana, KY Investigative Site FIN-10124

Cynthiana, Kentucky, United States

FIN-10080, Lexington, KY

Lexington, Kentucky, United States

Lexington, KY Investigative Site FIN-10118

Lexington, Kentucky, United States

FIN-10086, Louisville, KY

Louisville, Kentucky, United States

Louisville, KY Investigative Site FIN-10417

Louisville, Kentucky, United States

FIN-10079, Paducah, KY

Paducah, Kentucky, United States

FIN-10030, Baton Rouge, LA

Baton Rouge, Louisiana, United States

FIN-10106, Hammond, LA

Hammond, Louisiana, United States

FIN-10090, West Monroe, LA

West Monroe, Louisiana, United States

Minneapolis, MN Investigative Site FIN-10035

Minneapolis, Minnesota, United States

FIN-10002 Kansas City, MO Investigational Site

Kansas City, Missouri, United States

FIN-10318, Charlotte, NC

Charlotte, North Carolina, United States

Greenville, NC Investigative Site FIN-10122

Greenville, North Carolina, United States

FIN-10081, Akron, OH

Akron, Ohio, United States

FIN-10119, Centerville, OH

Centerville, Ohio, United States

FIN- 10112, Cincinnati, OH

Cincinnati, Ohio, United States

Orangeburg, SC Investigative Site FIN-10433

Orangeburg, South Carolina, United States

FIN-10015 Austin, TX Investigational Site

Austin, Texas, United States

FIN-10404, Denison, TX

Denison, Texas, United States

FIN-10085, Houston, TX

Houston, Texas, United States

Tyler, TX Investigative Site FIN-10422

Tyler, Texas, United States

FIN-10405, Layton, UT

Layton, Utah, United States

FIN-10053, Burlington, VT

Burlington, Vermont, United States

FIN-10402, Norfolk, VA

Norfolk, Virginia, United States

FIN-10093, Richmond, VA

Richmond, Virginia, United States

Salem, VA Investigative Site FIN-10048

Salem, Virginia, United States

Milwaukee, WI Investigative Site FIN-10428

Milwaukee, Wisconsin, United States

Lanus, Buenos Aires Investigative Site FIN-20024

Lanus, Buenos Aires, Argentina

Rosario, Santa Fe Investigative Site FIN-20022

Rosario, Santa Fe Province, Argentina

Buenos Aires Investigative Site FIN-20031

Buenos Aires, Argentina

Córdoba Investigative Site FIN-20025

Córdoba, Argentina

Córdoba Investigative Site FIN-20030

Córdoba, Argentina

San Juan, San Juan Investigative Site FIN-20020

San Juan, Argentina

San Juan, San Juan Investigative Site FIN-20021

San Juan, Argentina

FIN-21063, Rio Branco, Acre

Rio Branco, Acre, Brazil

FIN-21078, Maceió, Alagoas

Maceió, Alagoas, Brazil

FIN-21072 Salvador, Bahia - BA

Salvador, Bahia - BA, Brazil

Fortaleza, Ceará Investigative Site'FIN-21076

Fortaleza, Ceará, Brazil

Fortaleza, Ceará Investigative Site FIN-21055

Fortaleza, Ceará, Brazil

FIN-21032, Salvador, Bahia

Salvador, Estado de Bahia, Brazil

FIN-21028, Brasilia, Distrito Federal

Brasília, Federal District, Brazil

FIN-21053, Aparecida de Goiânia, Goiás

Aparecida de Goiânia, Goiás, Brazil

FIN-21003 Goiania, Goias Investigational Site

Goiânia, Goiás, Brazil

Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

FIN-21071, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

FIN-21051, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Belo Horizonte, Minas Gerais Investigative Site FIN-21079

Belo Horizonte, Minas Gerais, Brazil

FIN-21013, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

FIN-21056, Curitiba, Paraná

Curitiba, Paraná, Brazil

FIN-21047, Londrina, Paraná

Londrina, Paraná, Brazil

FIN-21021, Recife, Pernambuco

Recife, Pernambuco, Brazil

Recife, Pernambuco Investigative Site FIN-21086

Recife, Pernambuco, Brazil

FIN-21061, Recife, Pernambuco

Recife, Pernambuco, Brazil

Teresina, Piaui Investigative Site FIN-21050

Teresina, Piauí, Brazil

FIN-21001, Recife, Recife

Recife, Recife, Brazil

FIN-21016, Rio De Janeiro, Rio De Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

FIN-21014, Rio de Janeiro, Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

FIN-21024, Natal, Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

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

Caxias do Sul, Rio Grande do Sul, Brazil

FIN-21019, Porto Alegre, Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

FIN-21007, Joinville, Santa Catarina

Joinville, Santa Catarina, Brazil

FIN-21058, Aracaju, Sergipe

Aracaju, Sergipe, Brazil

FIN-21004 Braganca Paulista, Sao Paulo

Bragança Paulista, São Paulo, Brazil

Campinas, São Paulo Investigative Site' FIN-21083

Campinas, São Paulo, Brazil

FIN-21068, Guarulhos, São Paulo

Guarulhos, São Paulo, Brazil

FIN-21005, Itaquera, São Paulo

Itaquera, São Paulo, Brazil

FIN-21010, Osasco, São Paulo

Osasco, São Paulo, Brazil

FIN-21011, Presidente Prudente, São Paulo

Presidente Prudente, São Paulo, Brazil

FIN-21043, Santo André, São Paulo

Santo André, São Paulo, Brazil

São Carlos, São Paulo Investigative Site FIN-21075

São Carlos, São Paulo, Brazil

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

São José dos Campos, São Paulo, Brazil

FIN-21074, São Paulo, São Paulo

São Paulo, São Paulo, Brazil

FIN-21037, São Paulo, São Paulo

São Paulo, São Paulo, Brazil

FIN-21048, São Paulo, São Paulo

São Paulo, São Paulo, Brazil

FIN-21049 Sao Paulo, Sao Paulo

São Paulo, São Paulo, Brazil

FIN-21031, Votuporanga, São Paulo

Votuporanga, São Paulo, Brazil

Rio de Janeiro Investigative Site FIN-21034

Rio de Janeiro, Brazil

São Paulo Investigative Site FIN-21066

São Paulo, Brazil

Calgary, AB Investigative Site FIN-11009

Calgary, Alberta, Canada

FIN-11028, Edmonton, AB

Edmonton, Alberta, Canada

FIN-11011, Edmonton, AB

Edmonton, Alberta, Canada

FIN-11020, North Vancouver, BC

North Vancouver, British Columbia, Canada

FIN-11012 Surrey, BC Investigational Site

Surrey, British Columbia, Canada

FIN-11025, Victoria, BC

Victoria, British Columbia, Canada

FIN-11006, Winnipeg, MB

Winnipeg, Manitoba, Canada

FIN-11016, Sudbury, ON

Greater Sudbury, Ontario, Canada

FIN-11024, Kingston, ON

Kingston, Ontario, Canada

FIN-11010, London, ON

London, Ontario, Canada

FIN-11007, North York, ON

North York, Ontario, Canada

FIN-11008, Toronto, ON

Toronto, Ontario, Canada

FIN-11019, Toronto, ON

Toronto, Ontario, Canada

FIN-11005, Sherbrooke, QC

Sherbrooke, Quebec, Canada

FIN-30001, Zagreb, Croatia

Zagreb, Croatia, Croatia

FIN-30003, Zagreb, Croatia

Zagreb, Croatia, Croatia

FIN-30007, Zagreb, Croatia

Zagreb, Croatia, Croatia

Cepin Investigative Site FIN-30010

Čepin, Croatia

FIN-30004, Krapinske Toplice

Krapinske Toplice, Croatia

Osijek Investigative Site FIN-30008

Osijek, Croatia

FIN-31002, Brno, Czech Republic

Brno, Czech Republic, Czechia

Athens, Attica Investigative Site FIN-33004

Athens, Attica, Greece

Athens, Attica Investigative Site FIN-33009

Athens, Attica, Greece

Chaidari, Attica Investigative Site FIN-33006

Chaïdári, Attica, Greece

Kallithea, Attica Investigative Site FIN-33010

Kallithea, Attica, Greece

Nea Ionia, Attica Investigative Site FIN-33007

Nea Ionia, Attica, Greece

Thessaloniki, Central Macedonia Investigative Site FIN-33002

Thessaloniki, Central Macedonia, Greece

Alexandroupolis, Evros Investigative Site FIN-33012

Alexandroupoli, Evros, Greece

FIN-34004, Nyiregyhaza, Hungary

Nyíregyháza, Hungary, Hungary

Budapest Investigative Site FIN-34001

Budapest, Hungary

Gyöngyös Investigative Site FIN-34011

Gyöngyös, Hungary

Pecs Investigative Site FIN-34006

Pécs, Hungary

Brescia, BS Investigative Site FIN-35006

Brescia, BS, Italy

FIN-35003, Loc. Germaneto - Catanzaro, CZ

Germaneto, CZ, Italy

FIN-57002, Sapporo, Hokkaido

Sapporo, Hokkaido, Japan

FIN-57009, Isehara, Kanagawa

Isehara, Kanagawa, Japan

FIN-57006, Sagamiharam, Kanagawa

Sagamihara, Kanagawa, Japan

FIN-57001, Kyoto, Kyoto

Kyoto, Kyoto, Japan

FIN-57003, Sendai, Miyagi

Sendai, Miyagi, Japan

FIN-57004, Osaka, Osaka

Osaka, Osaka, Japan

FIN-57007, Suita, Osaka

Suita, Osaka, Japan

FIN-57009, Ota-ku, Tokyo

Ōta-ku, Tokyo, Japan

FIN-57005, Iwakuni, Yamaguchi

Iwakuni, Yamaguchi, Japan

FIN-37006, Lublin, Lublin

Lublin, Lublin Voivodeship, Poland

FIN-37002, Oswiecim, Oswiecim

Oświęcim, Oswiecim, Poland

Kraków Investigative Site FIN-37007

Krakow, Poland

Łódź Investigative Site FIN-37003

Lodz, Poland

Tychy, Investigative Site FIN-37009

Tychy, Poland

Gerona, Cataluña Investigative Site FIN-38017

Girona, Catalonia, Spain

A Coruña, Galicia Investigative Site FIN-38004

A Coruña, Galicia, Spain

FIN-38008, Santiago de Compostela, Galicia

Santiago de Compostela, Galicia, Spain

FIN-38002, Madrid, Madrid

Madrid, Madrid, Spain

FIN-38011, Madrid, Madrid

Madrid, Madrid, Spain

FIN-38006, Majadahonda, Madrid

Majadahonda, Madrid, Spain

FIN-38012, Málaga, Málaga

Málaga, Málaga, Spain

FIN-38009, Manises, Valencia

Manises, Valencia, Spain

FIN-38001, Valencia, Valencia

Valencia, Valencia, Spain

FIN-38007, Valencia, Valencia

Valencia, Valencia, Spain

Barcelona Investigative Site FIN-38010

Barcelona, Spain

Kandy, Central Province Investigative Site FIN-54001

Kandy, Central Province, Sri Lanka

Jaffna, Northern Province Investigative Site FIN-54014

Jaffna, Northern Province, Sri Lanka

Kurunegala, Northwestern Province Investigative Site FIN-54013

Kurunegala, Northwestern Province, Sri Lanka

Colombo, Western Province Investigative Site FIN-54004

Colombo, Western Province, Sri Lanka

Colombo, Western Province Investigative Site FIN-54006

Colombo, Western Province, Sri Lanka

Colombo, Western Province Investigative Site FIN-54007

Colombo, Western Province, Sri Lanka

Negombo, Western Province Investigative Site FIN-54002

Negombo, Western Province, Sri Lanka

Ragama, Western Province Investigative Site FIN-54008

Ragama, Western Province, Sri Lanka

FIN-39007, Bristol, UK

Bristol, UK, United Kingdom

London, UK

London, UK, United Kingdom

FIN-39001, Glasgow, UK

Glasgow, United Kingdom

FIN-39006, Southampton, UK

Southampton, United Kingdom