Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06024746

PHASE3

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

Sponsor: Colorado Prevention Center

View on ClinicalTrials.gov

Summary

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

Official title: Combined Efficacy and Safety of an Early, Intensive, Management Strategy With Finerenone and SGLT2 Inhibitor in Patients Hospitalized With Heart Failure (CONFIRMATION-HF)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2024-07-09

Completion Date

2027-11

Last Updated

2026-07-23

Healthy Volunteers

Conditions

Heart Failure

Interventions

DRUG

Finerenone

Oral finerenone.

DRUG

Empagliflozin

Oral empagliflozin.

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 * Current hospitalization or recently discharged with the primary diagnosis of heart failure * Heart failure signs and symptoms at the time of hospital admission * Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission * Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization) * Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide). * Negative pregnancy test and agreement to use adequate contraception during trial (female participants only) Exclusion Criteria: * Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis * Documented prior history of severe hyperkalemia in the setting of MRA use * Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i * Estimated glomerular filtration rate (eGFR) \<30 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 * Prior or planned heart transplant * Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure * Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or 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) * Any other condition or therapy which would make the patient unsuitable for this study

Locations (104)

CON-10004 Fairhope, AL Investigational Site

Fairhope, Alabama, United States

CON-10075 El Centro, CA Investigational Site

El Centro, California, United States

CON-10024 Sacramento, CA Investigational Site

Sacramento, California, United States

CON-10023, San Francisco, CA

San Francisco, California, United States

CON-10109, Van Nuys, CA

Van Nuys, California, United States

CON-10001, Aurora, CO

Aurora, Colorado, United States

CON-10005, Denver, CO

Denver, Colorado, United States

CON-10078, Hialeah, FL

Hialeah, Florida, United States

CON-10105, Miami, FL

Miami, Florida, United States

CON-10113, Miramar, FL

Miramar, Florida, United States

CON-10022 Atlanta, GA Investigational Site

Atlanta, Georgia, United States

CON-10021, Glenview, IL

Glenview, Illinois, United States

CON-10041, Island Lake, IL

Island Lake, Illinois, United States

CON-10025, Naperville, IL

Naperville, Illinois, United States

CON-10019, Peoria, IL

Peoria, Illinois, United States

CON-10064, Merrillville, IN

Merrillville, Indiana, United States

CON-10080, Lexington, KY

Lexington, Kentucky, United States

CON-10086, Louisville, Kentucky

Louisville, Kentucky, United States

CON-10079, Paducah, KY

Paducah, Kentucky, United States

CON-10030 Baton Rouge, LA Investigational Site

Baton Rouge, Louisiana, United States

CON-10090, West Monroe, LA

West Monroe, Louisiana, United States

CON-10002 Kansas City, MO Investigative Site

Kansas City, Missouri, United States

CON-10018, Omaha, NE

Omaha, Nebraska, United States

CON-10318, Charlotte, NC

Charlotte, North Carolina, United States

CON-10119, Centerville, OH

Centerville, Ohio, United States

CON-10051, Chattanooga, TN

Chattanooga, Tennessee, United States

CON-10045 Amarillo, TX Investigational Site

Amarillo, Texas, United States

CON-10015 Austin, TX Investigational Site

Austin, Texas, United States

CON-10304, Denison, TX

Denison, Texas, United States

CON-10301, Fort Worth, TX

Fort Worth, Texas, United States

CON-10085, Houston, TX

Houston, Texas, United States

CON-10305, Layton, UT

Layton, Utah, United States

CON-10009, Norfolk, VA

Norfolk, Virginia, United States

CON-21036, Rio Branco, Acre

Rio Branco, Acre, Brazil

CON-21064, Arapiraca, Alagoas, Brazil

Arapiraca, Alagoas, Brazil

CON-21017, Linhares, Espirito Santo

Linhares, Espírito Santo, Brazil

CON-21032, Salvador, Bahia

Salvador, Estado de Bahia, Brazil

CON-21028, Brasilia, Distrito Federal

Brasília, Federal District, Brazil

CON-21053, Aparecida de Goiânia, Goias

Aparecida de Goiânia, Goiás, Brazil

CON-21003 Goiania, Goias Investigational Site

Goiânia, Goiás, Brazil

CON-21020, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

CON-21051, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

CON-21013, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

CON-21009, Poços de Caldas, Minas Gerais

Poços de Caldas, Minas Gerais, Brazil

CON-21056, Curitiba, Paraná

Curitiba, Paraná, Brazil

CON-21038, Curitiba, Paraná

Curitiba, Paraná, Brazil

CON-21047, Londrina, Paraná

Londrina, Paraná, Brazil

CON-21001, Recife, Recife

Recife, Recife, Brazil

CON-21016, Rio De Janeiro, Rio De Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

CON-21014, Rio de Janeiro, Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

CON-21024, Natal, Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

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

Caxias do Sul, Rio Grande do Sul, Brazil

CON-21042, Passo Fundo, Rio Grande do Sul

Passo Fundo, Rio Grande do Sul, Brazil

CON-21007 Joinville, Santa Catarina Investigational Site

Joinville, Santa Catarina, Brazil

CON-21058, Aracaju, Sergipe

Aracaju, Sergipe, Brazil

CON-21057, Atibaia, São Paulo

Atibaia, São Paulo, Brazil

CON-21004 Braganca Paulista, Sao Paulo Investigational Site

Bragança Paulista, São Paulo, Brazil

CON-21005, Itaquera, São Paulo

Itaquera, São Paulo, Brazil

CON-21010, Osasco, São Paulo

Osasco, São Paulo, Brazil

CON-21011, Presidente Prudente, São Paulo

Presidente Prudente, São Paulo, Brazil

CON021043, Santo André, São Paulo

Santo André, São Paulo, Brazil

CON-21074, São Paulo, São Paulo

São Paulo, São Paulo, Brazil

CON-21062, São Paulo, São Paulo

São Paulo, São Paulo, Brazil

CON-21037, São Paulo, São Paulo

São Paulo, São Paulo, Brazil

CON-21048, São Paulo, São Paulo

São Paulo, São Paulo, Brazil

CON-21049 Sao Paulo, Sao Paulo Investigational Site

São Paulo, São Paulo, Brazil

CON-21031, Votuporanga, São Paulo

Votuporanga, São Paulo, Brazil

CON-11011, Edmonton, AB

Edmonton, Alberta, Canada

CON-11012 Surry, BC Investigational Site

Surrey, British Columbia, Canada

CON-11016, Sudbury, ON

Greater Sudbury, Ontario, Canada

CON-11010, London, ON

London, Ontario, Canada

CON-11007 North York, ON Investigational Site

North York, Ontario, Canada

CON-11008, Toronto, ON

Toronto, Ontario, Canada

CON-11019, Toronto, ON

Toronto, Ontario, Canada

CON-11001, Toronto, ON

Toronto, Ontario, Canada

CON-11026, Montreal, Quebec

Montreal, Quebec, Canada

CON-11005 Sherbrooke, QC Investigational Site

Sherbrooke, Quebec, Canada

CON-56002, Guangzhou, Guangdong province

Guangzhou, Guangdong, China

CON-56008, Changsha, Hunan

Changsha, Hunan, China

CON-56004, Jinan, Shandong Province

Jinan, Shandong, China

CON-56001, Shanghai, Shanghai

Shanghai, Shanghai Municipality, China

CON-56009, Shanghai, Shanghai

Shanghai, Shanghai Municipality, China

CON-56005, Taiyuan, Shanxi province

Taiyuan, Shanxi, China

CON-56006, Xi'an city, Shanxi Province

Xi’an, Shanxi, China

CON-56007, Chengdu City, Sichuan Province

Chengdu, Sichuan, China

CON-56003, Tianjin, Tianjin

Tianjin, Tianjin Municipality, China

CON-56010, Hangzhou, Zhejiang Province

Hangzhou, Zhejiang, China

CON-51006, Ahmedabad, Gujarat

Ahmedabad, Gujarat, India

CON-51013, Bangalore, Karnataka

Bangalore, Karnataka, India

CON-51009, Nagpur, Maharashtra

Nagpur, Maharashtra, India

CON-38008, Santiago de Compostela, Galicia

Santiago de Compostela, Galicia, Spain

CON-38002, Madrid, Madrid

Madrid, Madrid, Spain

CON-38011, Madrid, Madrid

Madrid, Madrid, Spain

CON-38012, Malaga, Malaga

Málaga, Malaga, Spain

CON-38009, Manises, Valencia

Manises, Valencia, Spain

CON-38001, Valencia, Valencia

Valencia, Valencia, Spain

CON-54001, Kandy, Central Province

Kandy, Central Province, Sri Lanka

CON-54005, Colombo, Western Province

Colombo, Western Province, Sri Lanka

CON-54007, Colombo, Western Province

Colombo, Western Province, Sri Lanka

CON-54008, Ragama, Western Province

Ragama, Western Province, Sri Lanka

CON-39010, Bournemouth, Dorset

Bournemouth, Dorset, United Kingdom

CON-39002, London, UK

London, UK, United Kingdom

CON-39007, Bristol, UK

Bristol, United Kingdom

CON-39001, Glasgow, UK

Glasgow, United Kingdom

Clinical Research Directory

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (104)