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NCT06033950PHASE3Recruiting

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

Colorado Prevention Center

Start Date

8/20/2024

Completion Date

1/1/2028

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).

Detailed Description

This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced ejection fraction.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Finerenone

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Heart Failure

Locations

FIN-10004 Fairhope, AL Investigational Site

Fairhope, Alabama 36532

United States

Phoenix, AZ Investigative Site FIN-10115

Phoenix, Arizona 85006

United States

FIN-10401, Yuma, AZ

Yuma, Arizona 85365

United States

Chula Vista, CA Investigative Site FIN-10419

Chula Vista, California 91910

United States

Chula Vista, CA Investigative Site FIN-10111

Chula Vista, California 91911

United States

FIN-10407, Northridge, CA

Northridge, California 91324

United States

FIN-10412, Orange, CA

Orange, California 92866

United States

FIN-10070, Pamona, CA

Pomona, California 91767

United States

FIN-10024, Sacramento, CA

Sacramento, California 95816

United States

FIN-10406, San Diego, CA

San Diego, California 91127

United States

San Diego, CA Investigative Site FIN-10420

San Diego, California 92111

United States

FIN-10075 San Diego, CA Investigational Site

San Diego, California 92243

United States

San Francisco, CA Investigative Site FIN-10023

San Francisco, California 94118

United States

FIN-10423, Sherman Oaks, CA

Sherman Oaks, California 91403

United States

FON-10409, Tarzana, CA

Tarzana, California 91356

United States

FIN-10109, Van Nuys, CA

Van Nuys, California 91405

United States

FIN-10408, West Covina, CA

West Covina, California 91790

United States

FIN-10013, West Hills, CA

West Hills, California 91307

United States

FIN-10110, Aurora, CO

Aurora, Colorado 80012

United States

FIN-10001, Aurora, CO

Aurora, Colorado 80045

United States

Bradenton, FL Investigative Site FIN-10125

Bradenton, Florida 34209

United States

FIN-10104, Hialeah, FL

Hialeah, Florida 33012

United States

FIN-10028, Jacksonville, FL

Jacksonville, Florida 32209

United States

FIN-10105, Miami, FL

Miami, Florida 33135

United States

FIN-10113, Miramar, FL

Miramar, Florida 33027

United States

FIN-10019, Peoria, IL

Peoria, Illinois 61603

United States

FIN-10064, Merrillville, IN

Merrillville, Indiana 46410

United States

Cynthiana, KY Investigative Site FIN-10124

Cynthiana, Kentucky 41031

United States

FIN-10080, Lexington, KY

Lexington, Kentucky 40503

United States

Lexington, KY Investigative Site FIN-10118

Lexington, Kentucky 40536

United States

FIN-10086, Louisville, KY

Louisville, Kentucky 40205

United States

Louisville, KY Investigative Site FIN-10417

Louisville, Kentucky 40205

United States

FIN-10079, Paducah, KY

Paducah, Kentucky 42003

United States

FIN-10030, Baton Rouge, LA

Baton Rouge, Louisiana 70808

United States

FIN-10106, Hammond, LA

Hammond, Louisiana 70403

United States

FIN-10090, West Monroe, LA

West Monroe, Louisiana 71291

United States

Minneapolis, MN Investigative Site FIN-10035

Minneapolis, Minnesota 55417

United States

FIN-10002 Kansas City, MO Investigational Site

Kansas City, Missouri 64111

United States

FIN-10318, Charlotte, NC

Charlotte, North Carolina 28207

United States

Greenville, NC Investigative Site FIN-10122

Greenville, North Carolina 27834

United States

FIN-10081, Akron, OH

Akron, Ohio 44304

United States

FIN-10119, Centerville, OH

Centerville, Ohio 45459

United States

FIN- 10112, Cincinnati, OH

Cincinnati, Ohio 45219

United States

Orangeburg, SC Investigative Site FIN-10433

Orangeburg, South Carolina 29118

United States

FIN-10015 Austin, TX Investigational Site

Austin, Texas 78705

United States

FIN-10404, Denison, TX

Denison, Texas 75020

United States

FIN-10085, Houston, TX

Houston, Texas 77030

United States

Tyler, TX Investigative Site FIN-10422

Tyler, Texas 75702

United States

FIN-10405, Layton, UT

Layton, Utah 84041

United States

FIN-10053, Burlington, VT

Burlington, Vermont 05401

United States

FIN-10402, Norfolk, VA

Norfolk, Virginia 23510

United States

FIN-10093, Richmond, VA

Richmond, Virginia 23298-5051

United States

Salem, VA Investigative Site FIN-10048

Salem, Virginia 24153

United States

Milwaukee, WI Investigative Site FIN-10428

Milwaukee, Wisconsin 53215

United States

Lanus, Buenos Aires Investigative Site FIN-20024

Lanus, Buenos Aires 1824

Argentina

Rosario, Santa Fe Investigative Site FIN-20022

Rosario, Santa Fe Province 2300

Argentina

Buenos Aires Investigative Site FIN-20031

Buenos Aires, 1425

Argentina

Córdoba Investigative Site FIN-20025

Córdoba, 5000

Argentina

Córdoba Investigative Site FIN-20030

Córdoba, 5000

Argentina

San Juan, San Juan Investigative Site FIN-20020

San Juan, J5402DIL

Argentina

San Juan, San Juan Investigative Site FIN-20021

San Juan, J5402DIL

Argentina

FIN-21063, Rio Branco, Acre

Rio Branco, Acre 69915-030

Brazil

FIN-21078, Maceió, Alagoas

Maceió, Alagoas 57051-160

Brazil

FIN-21072 Salvador, Bahia - BA

Salvador, Bahia - BA 40290-000

Brazil

Fortaleza, Ceará Investigative Site'FIN-21076

Fortaleza, Ceará 60430275

Brazil

Fortaleza, Ceará Investigative Site FIN-21055

Fortaleza, Ceará 60864-190

Brazil

FIN-21032, Salvador, Bahia

Salvador, Estado de Bahia 40050-410

Brazil

FIN-21028, Brasilia, Distrito Federal

Brasília, Federal District 70390-700

Brazil

FIN-21053, Aparecida de Goiânia, Goiás

Aparecida de Goiânia, Goiás 74936-600

Brazil

FIN-21003 Goiania, Goias Investigational Site

Goiânia, Goiás 74453-200

Brazil

Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais 30110-934

Brazil

FIN-21071, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais 30150-320

Brazil

FIN-21051, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais 30220-140

Brazil

Belo Horizonte, Minas Gerais Investigative Site FIN-21079

Belo Horizonte, Minas Gerais 30220-330

Brazil

FIN-21013, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais 30441-070

Brazil

FIN-21056, Curitiba, Paraná

Curitiba, Paraná 80060-900

Brazil

FIN-21047, Londrina, Paraná

Londrina, Paraná 86.038-350

Brazil

FIN-21021, Recife, Pernambuco

Recife, Pernambuco 50100-040

Brazil

Recife, Pernambuco Investigative Site FIN-21086

Recife, Pernambuco 51.110-160

Brazil

FIN-21061, Recife, Pernambuco

Recife, Pernambuco 52010-075

Brazil

Teresina, Piaui Investigative Site FIN-21050

Teresina, Piauí 64001-450

Brazil

FIN-21001, Recife, Recife

Recife, Recife 50720-110

Brazil

FIN-21016, Rio De Janeiro, Rio De Janeiro

Rio de Janeiro, Rio de Janeiro 20551-030

Brazil

FIN-21014, Rio de Janeiro, Rio de Janeiro

Rio de Janeiro, Rio de Janeiro 22240-006

Brazil

FIN-21024, Natal, Rio Grande do Norte

Natal, Rio Grande do Norte 5902050

Brazil

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

Caxias do Sul, Rio Grande do Sul 95070-560

Brazil

FIN-21019, Porto Alegre, Rio Grande do Sul

Porto Alegre, Rio Grande do Sul 90840-440

Brazil

FIN-21007, Joinville, Santa Catarina

Joinville, Santa Catarina 89200-000

Brazil

FIN-21058, Aracaju, Sergipe

Aracaju, Sergipe 49055-210

Brazil

FIN-21004 Braganca Paulista, Sao Paulo

Bragança Paulista, São Paulo 12916542

Brazil

Campinas, São Paulo Investigative Site' FIN-21083

Campinas, São Paulo 13083-190

Brazil

FIN-21068, Guarulhos, São Paulo

Guarulhos, São Paulo 07197-000

Brazil

FIN-21005, Itaquera, São Paulo

Itaquera, São Paulo 08270-120

Brazil

FIN-21010, Osasco, São Paulo

Osasco, São Paulo 06013-070

Brazil

FIN-21011, Presidente Prudente, São Paulo

Presidente Prudente, São Paulo 19050-680

Brazil

FIN-21043, Santo André, São Paulo

Santo André, São Paulo 09090790

Brazil

São Carlos, São Paulo Investigative Site FIN-21075

São Carlos, São Paulo 13566-448

Brazil

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

São José dos Campos, São Paulo 12243000

Brazil

FIN-21074, São Paulo, São Paulo

São Paulo, São Paulo 01229-010

Brazil

FIN-21037, São Paulo, São Paulo

São Paulo, São Paulo 01323-001

Brazil

FIN-21048, São Paulo, São Paulo

São Paulo, São Paulo 04004-30

Brazil

FIN-21049 Sao Paulo, Sao Paulo

São Paulo, São Paulo 05652-900

Brazil

FIN-21031, Votuporanga, São Paulo

Votuporanga, São Paulo 15505-189

Brazil

Rio de Janeiro Investigative Site FIN-21034

Rio de Janeiro, 22280-003

Brazil

São Paulo Investigative Site FIN-21066

São Paulo, 05403-000

Brazil

Calgary, AB Investigative Site FIN-11009

Calgary, Alberta T2N 1N4

Canada

FIN-11028, Edmonton, AB

Edmonton, Alberta T5H 4B9

Canada

FIN-11011, Edmonton, AB

Edmonton, Alberta T6G 2B7

Canada

FIN-11020, North Vancouver, BC

North Vancouver, British Columbia V7M 2H4

Canada

FIN-11012 Surrey, BC Investigational Site

Surrey, British Columbia V3V OC6

Canada

FIN-11025, Victoria, BC

Victoria, British Columbia V8R 1B2

Canada

FIN-11006, Winnipeg, MB

Winnipeg, Manitoba R2H 2A6

Canada

FIN-11016, Sudbury, ON

Greater Sudbury, Ontario P3E 5J1

Canada

FIN-11024, Kingston, ON

Kingston, Ontario K7L 2V7

Canada

FIN-11010, London, ON

London, Ontario N6A 5A5

Canada

FIN-11007, North York, ON

North York, Ontario M6B 3H7

Canada

FIN-11008, Toronto, ON

Toronto, Ontario M4N 3M5

Canada

FIN-11019, Toronto, ON

Toronto, Ontario M5B 1W8

Canada

FIN-11005, Sherbrooke, QC

Sherbrooke, Quebec J1H 5N4

Canada

FIN-30001, Zagreb, Croatia

Zagreb, Croatia 10000

Croatia

FIN-30003, Zagreb, Croatia

Zagreb, Croatia 10000

Croatia

FIN-30007, Zagreb, Croatia

Zagreb, Croatia 10000

Croatia

Cepin Investigative Site FIN-30010

Čepin, 31431

Croatia

FIN-30004, Krapinske Toplice

Krapinske Toplice, 49217

Croatia

Osijek Investigative Site FIN-30008

Osijek, 31000

Croatia

FIN-31002, Brno, Czech Republic

Brno, Czech Republic 612 00

Czechia

Athens, Attica Investigative Site FIN-33004

Athens, Attica 115 27

Greece

Athens, Attica Investigative Site FIN-33009

Athens, Attica 155 62

Greece

Chaidari, Attica Investigative Site FIN-33006

Chaïdári, Attica 124 62

Greece

Kallithea, Attica Investigative Site FIN-33010

Kallithea, Attica 176 74

Greece

Nea Ionia, Attica Investigative Site FIN-33007

Nea Ionia, Attica 142 33

Greece

Thessaloniki, Central Macedonia Investigative Site FIN-33002

Thessaloniki, Central Macedonia 546 36

Greece

Alexandroupolis, Evros Investigative Site FIN-33012

Alexandroupoli, Evros 68100

Greece

FIN-34004, Nyiregyhaza, Hungary

Nyíregyháza, Hungary 4400

Hungary

Budapest Investigative Site FIN-34001

Budapest, 1122

Hungary

Gyöngyös Investigative Site FIN-34011

Gyöngyös, 3200

Hungary

Pecs Investigative Site FIN-34006

Pécs, 7624

Hungary

Brescia, BS Investigative Site FIN-35006

Brescia, BS 25123

Italy

FIN-35003, Loc. Germaneto - Catanzaro, CZ

Germaneto, CZ 88100

Italy

FIN-57002, Sapporo, Hokkaido

Sapporo, Hokkaido 060-8648

Japan

FIN-57009, Isehara, Kanagawa

Isehara, Kanagawa 259-1193

Japan

FIN-57006, Sagamiharam, Kanagawa

Sagamihara, Kanagawa 252-5188

Japan

FIN-57001, Kyoto, Kyoto

Kyoto, Kyoto 606-8507

Japan

FIN-57003, Sendai, Miyagi

Sendai, Miyagi 980-8574

Japan

FIN-57004, Osaka, Osaka

Osaka, Osaka 530-0005

Japan

FIN-57007, Suita, Osaka

Suita, Osaka 564-8565

Japan

FIN-57009, Ota-ku, Tokyo

Ōta-ku, Tokyo 143-8540

Japan

FIN-57005, Iwakuni, Yamaguchi

Iwakuni, Yamaguchi 740-8510

Japan

FIN-37006, Lublin, Lublin

Lublin, Lublin Voivodeship 20-011

Poland

FIN-37002, Oswiecim, Oswiecim

Oświęcim, Oswiecim 32-600

Poland

Kraków Investigative Site FIN-37007

Krakow, 30-702

Poland

Łódź Investigative Site FIN-37003

Lodz, 92-213

Poland

Tychy, Investigative Site FIN-37009

Tychy, 43-100

Poland

Gerona, Cataluña Investigative Site FIN-38017

Girona, Catalonia 17007

Spain

A Coruña, Galicia Investigative Site FIN-38004

A Coruña, Galicia 15006

Spain

FIN-38008, Santiago de Compostela, Galicia

Santiago de Compostela, Galicia 15706

Spain

FIN-38002, Madrid, Madrid

Madrid, Madrid 28034

Spain

FIN-38011, Madrid, Madrid

Madrid, Madrid 28046

Spain

FIN-38006, Majadahonda, Madrid

Majadahonda, Madrid 28222

Spain

FIN-38012, Málaga, Málaga

Málaga, Málaga 29010

Spain

FIN-38009, Manises, Valencia

Manises, Valencia 46940

Spain

FIN-38001, Valencia, Valencia

Valencia, Valencia 46026

Spain

FIN-38007, Valencia, Valencia

Valencia, Valencia 46026

Spain

Barcelona Investigative Site FIN-38010

Barcelona, 08907

Spain

Kandy, Central Province Investigative Site FIN-54001

Kandy, Central Province 2000

Sri Lanka

Jaffna, Northern Province Investigative Site FIN-54014

Jaffna, Northern Province 40000

Sri Lanka

Kurunegala, Northwestern Province Investigative Site FIN-54013

Kurunegala, Northwestern Province 60000

Sri Lanka

Colombo, Western Province Investigative Site FIN-54004

Colombo, Western Province 01000

Sri Lanka

Colombo, Western Province Investigative Site FIN-54006

Colombo, Western Province 01000

Sri Lanka

Colombo, Western Province Investigative Site FIN-54007

Colombo, Western Province 10350

Sri Lanka

Negombo, Western Province Investigative Site FIN-54002

Negombo, Western Province 11500

Sri Lanka

Ragama, Western Province Investigative Site FIN-54008

Ragama, Western Province 11010

Sri Lanka

FIN-39007, Bristol, UK

Bristol, UK BS10 5NB

United Kingdom

London, UK

London, UK SW17 0QT

United Kingdom

FIN-39001, Glasgow, UK

Glasgow, G4 0SF

United Kingdom

FIN-39006, Southampton, UK

Southampton, SO16 6YD

United Kingdom