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NCT06024746PHASE3Recruiting

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

Colorado Prevention Center

Start Date

7/9/2024

Completion Date

11/1/2027

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.

Detailed Description

This is an international, randomized, controlled, open-label, trial of an early, intensive management strategy using the combination of finerenone plus sodium-glucose co-transporter 2 inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).

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 * 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

Interventions

DRUG

Finerenone

DRUG

Empagliflozin

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

CON-10004 Fairhope, AL Investigational Site

Fairhope, Alabama 36532

United States

CON-10075 El Centro, CA Investigational Site

El Centro, California 92243

United States

CON-10024 Sacramento, CA Investigational Site

Sacramento, California 95816

United States

CON-10023, San Francisco, CA

San Francisco, California 94118

United States

CON-10109, Van Nuys, CA

Van Nuys, California 91405

United States

CON-10001, Aurora, CO

Aurora, Colorado 80045

United States

CON-10005, Denver, CO

Denver, Colorado 80204

United States

CON-10078, Hialeah, FL

Hialeah, Florida 33012

United States

CON-10105, Miami, FL

Miami, Florida 33135

United States

CON-10113, Miramar, FL

Miramar, Florida 33027

United States

CON-10022 Atlanta, GA Investigational Site

Atlanta, Georgia 30303

United States

CON-10021, Glenview, IL

Glenview, Illinois 60026

United States

CON-10041, Island Lake, IL

Island Lake, Illinois 60042

United States

CON-10025, Naperville, IL

Naperville, Illinois 60540

United States

CON-10019, Peoria, IL

Peoria, Illinois 61603

United States

CON-10064, Merrillville, IN

Merrillville, Indiana 46410

United States

CON-10080, Lexington, KY

Lexington, Kentucky 40503

United States

CON-10086, Louisville, Kentucky

Louisville, Kentucky 40205

United States

CON-10079, Paducah, KY

Paducah, Kentucky 42003

United States

CON-10030 Baton Rouge, LA Investigational Site

Baton Rouge, Louisiana 70808

United States

CON-10090, West Monroe, LA

West Monroe, Louisiana 71291

United States

CON-10002 Kansas City, MO Investigative Site

Kansas City, Missouri 64111

United States

CON-10018, Omaha, NE

Omaha, Nebraska 68105

United States

CON-10318, Charlotte, NC

Charlotte, North Carolina 28207

United States

CON-10119, Centerville, OH

Centerville, Ohio 45459

United States

CON-10051, Chattanooga, TN

Chattanooga, Tennessee 37403

United States

CON-10045 Amarillo, TX Investigational Site

Amarillo, Texas 79106

United States

CON-10015 Austin, TX Investigational Site

Austin, Texas 78705

United States

CON-10304, Denison, TX

Denison, Texas 75020

United States

CON-10301, Fort Worth, TX

Fort Worth, Texas 76104

United States

CON-10085, Houston, TX

Houston, Texas 77030

United States

CON-10305, Layton, UT

Layton, Utah 84041

United States

CON-10009, Norfolk, VA

Norfolk, Virginia 23507

United States

CON-21036, Rio Branco, Acre

Rio Branco, Acre 69915-030

Brazil

CON-21064, Arapiraca, Alagoas, Brazil

Arapiraca, Alagoas 57315-745

Brazil

CON-21017, Linhares, Espirito Santo

Linhares, Espírito Santo 29900-010

Brazil

CON-21032, Salvador, Bahia

Salvador, Estado de Bahia 40050-410

Brazil

CON-21028, Brasilia, Distrito Federal

Brasília, Federal District 70390-700

Brazil

CON-21053, Aparecida de Goiânia, Goias

Aparecida de Goiânia, Goiás 74936-600

Brazil

CON-21003 Goiania, Goias Investigational Site

Goiânia, Goiás 74453-200

Brazil

CON-21020, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais 30180-080

Brazil

CON-21051, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais 30220-140

Brazil

CON-21013, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais 30441-070

Brazil

CON-21009, Poços de Caldas, Minas Gerais

Poços de Caldas, Minas Gerais 37706

Brazil

CON-21056, Curitiba, Paraná

Curitiba, Paraná 80060-900

Brazil

CON-21038, Curitiba, Paraná

Curitiba, Paraná 80230-130

Brazil

CON-21047, Londrina, Paraná

Londrina, Paraná 86038

Brazil

CON-21001, Recife, Recife

Recife, Recife 50720-110

Brazil

CON-21016, Rio De Janeiro, Rio De Janeiro

Rio de Janeiro, Rio de Janeiro 20551-030

Brazil

CON-21014, Rio de Janeiro, Rio de Janeiro

Rio de Janeiro, Rio de Janeiro 22240-006

Brazil

CON-21024, Natal, Rio Grande do Norte

Natal, Rio Grande do Norte 59020-500

Brazil

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

Caxias do Sul, Rio Grande do Sul 95070560

Brazil

CON-21042, Passo Fundo, Rio Grande do Sul

Passo Fundo, Rio Grande do Sul 99010

Brazil

CON-21007 Joinville, Santa Catarina Investigational Site

Joinville, Santa Catarina 89200-000

Brazil

CON-21058, Aracaju, Sergipe

Aracaju, Sergipe 49055-210

Brazil

CON-21057, Atibaia, São Paulo

Atibaia, São Paulo 12944-060

Brazil

CON-21004 Braganca Paulista, Sao Paulo Investigational Site

Bragança Paulista, São Paulo 12916542

Brazil

CON-21005, Itaquera, São Paulo

Itaquera, São Paulo 08270-120

Brazil

CON-21010, Osasco, São Paulo

Osasco, São Paulo 06013-070

Brazil

CON-21011, Presidente Prudente, São Paulo

Presidente Prudente, São Paulo 19050-680

Brazil

CON021043, Santo André, São Paulo

Santo André, São Paulo 09090-790

Brazil

CON-21074, São Paulo, São Paulo

São Paulo, São Paulo 01229-010

Brazil

CON-21062, São Paulo, São Paulo

São Paulo, São Paulo 01317-002

Brazil

CON-21037, São Paulo, São Paulo

São Paulo, São Paulo 01323-001

Brazil

CON-21048, São Paulo, São Paulo

São Paulo, São Paulo 04004-30

Brazil

CON-21049 Sao Paulo, Sao Paulo Investigational Site

São Paulo, São Paulo 05652-900

Brazil

CON-21031, Votuporanga, São Paulo

Votuporanga, São Paulo 15505-189

Brazil

CON-11011, Edmonton, AB

Edmonton, Alberta T6G 2B7

Canada

CON-11012 Surry, BC Investigational Site

Surrey, British Columbia V3V OC6

Canada

CON-11016, Sudbury, ON

Greater Sudbury, Ontario P3E 5J1

Canada

CON-11010, London, ON

London, Ontario N6A 5A5

Canada

CON-11007 North York, ON Investigational Site

North York, Ontario M6B 3H7

Canada

CON-11008, Toronto, ON

Toronto, Ontario M4N 3M5

Canada

CON-11019, Toronto, ON

Toronto, Ontario M5B 1W8

Canada

CON-11001, Toronto, ON

Toronto, Ontario M5G 2C4

Canada

CON-11026, Montreal, Quebec

Montreal, Quebec H2X 1R9

Canada

CON-11005 Sherbrooke, QC Investigational Site

Sherbrooke, Quebec J1H 5N4

Canada

CON-56002, Guangzhou, Guangdong province

Guangzhou, Guangdong 510080

China

CON-56008, Changsha, Hunan

Changsha, Hunan 410011

China

CON-56004, Jinan, Shandong Province

Jinan, Shandong 250001/250021

China

CON-56001, Shanghai, Shanghai

Shanghai, Shanghai Municipality 200032

China

CON-56009, Shanghai, Shanghai

Shanghai, Shanghai Municipality 200120

China

CON-56005, Taiyuan, Shanxi province

Taiyuan, Shanxi 030027

China

CON-56006, Xi'an city, Shanxi Province

Xi’an, Shanxi 710038

China

CON-56007, Chengdu City, Sichuan Province

Chengdu, Sichuan 610072

China

CON-56003, Tianjin, Tianjin

Tianjin, Tianjin Municipality 300052

China

CON-56010, Hangzhou, Zhejiang Province

Hangzhou, Zhejiang 311200

China

CON-51006, Ahmedabad, Gujarat

Ahmedabad, Gujarat 380005

India

CON-51013, Bangalore, Karnataka

Bangalore, Karnataka 560002

India

CON-51009, Nagpur, Maharashtra

Nagpur, Maharashtra 440033

India

CON-38008, Santiago de Compostela, Galicia

Santiago de Compostela, Galicia 15706

Spain

CON-38002, Madrid, Madrid

Madrid, Madrid 28034

Spain

CON-38011, Madrid, Madrid

Madrid, Madrid 28046

Spain

CON-38012, Malaga, Malaga

Málaga, Malaga 29010

Spain

CON-38009, Manises, Valencia

Manises, Valencia 46940

Spain

CON-38001, Valencia, Valencia

Valencia, Valencia 46010

Spain

CON-54001, Kandy, Central Province

Kandy, Central Province 2000

Sri Lanka

CON-54005, Colombo, Western Province

Colombo, Western Province 01000

Sri Lanka

CON-54007, Colombo, Western Province

Colombo, Western Province 10350

Sri Lanka

CON-54008, Ragama, Western Province

Ragama, Western Province 11010

Sri Lanka

CON-39010, Bournemouth, Dorset

Bournemouth, Dorset BH7 7DW

United Kingdom

CON-39002, London, UK

London, UK SW17 0QT

United Kingdom

CON-39007, Bristol, UK

Bristol, BS10 5NB

United Kingdom

CON-39001, Glasgow, UK

Glasgow, G4 0SF

United Kingdom