A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) | NCT06024746 | Trialant

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) | NCT06024746 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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

CON-10004 Fairhope, AL Investigational SiteRecruiting

Fairhope, Alabama 36532, United States

CON-10075 El Centro, CA Investigational SiteRecruiting

El Centro, California 92243, United States

CON-10024 Sacramento, CA Investigational SiteRecruiting

Sacramento, California 95816, United States

CON-10023, San Francisco, CARecruiting

San Francisco, California 94118, United States

CON-10109, Van Nuys, CARecruiting

Van Nuys, California 91405, United States

CON-10001, Aurora, CORecruiting

Aurora, Colorado 80045, United States

CON-10005, Denver, CORecruiting

Denver, Colorado 80204, United States

CON-10078, Hialeah, FLRecruiting

Hialeah, Florida 33012, United States

CON-10105, Miami, FLRecruiting

Miami, Florida 33135, United States

CON-10113, Miramar, FLRecruiting

Miramar, Florida 33027, United States

CON-10022 Atlanta, GA Investigational SiteRecruiting

Atlanta, Georgia 30303, United States

CON-10021, Glenview, ILRecruiting

Glenview, Illinois 60026, United States

CON-10041, Island Lake, ILRecruiting

Island Lake, Illinois 60042, United States

CON-10025, Naperville, ILRecruiting

Naperville, Illinois 60540, United States

CON-10019, Peoria, ILRecruiting

Peoria, Illinois 61603, United States

CON-10064, Merrillville, INRecruiting

Merrillville, Indiana 46410, United States

CON-10080, Lexington, KYRecruiting

Lexington, Kentucky 40503, United States

CON-10086, Louisville, KentuckyRecruiting

Louisville, Kentucky 40205, United States

CON-10079, Paducah, KYRecruiting

Paducah, Kentucky 42003, United States

CON-10030 Baton Rouge, LA Investigational SiteRecruiting

Baton Rouge, Louisiana 70808, United States

CON-10090, West Monroe, LARecruiting

West Monroe, Louisiana 71291, United States

CON-10002 Kansas City, MO Investigative SiteRecruiting

Kansas City, Missouri 64111, United States

CON-10018, Omaha, NERecruiting

Omaha, Nebraska 68105, United States

CON-10318, Charlotte, NCRecruiting

Charlotte, North Carolina 28207, United States

CON-10119, Centerville, OHRecruiting

Centerville, Ohio 45459, United States

CON-10051, Chattanooga, TNRecruiting

Chattanooga, Tennessee 37403, United States

CON-10045 Amarillo, TX Investigational SiteRecruiting

Amarillo, Texas 79106, United States

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Austin, Texas 78705, United States

CON-10304, Denison, TXRecruiting

Denison, Texas 75020, United States

CON-10301, Fort Worth, TXRecruiting

Fort Worth, Texas 76104, United States

CON-10085, Houston, TXRecruiting

Houston, Texas 77030, United States

CON-10305, Layton, UTRecruiting

Layton, Utah 84041, United States

CON-10009, Norfolk, VARecruiting

Norfolk, Virginia 23507, United States

CON-21036, Rio Branco, AcreRecruiting

Rio Branco, Acre 69915-030, Brazil

CON-21064, Arapiraca, Alagoas, BrazilRecruiting

Arapiraca, Alagoas 57315-745, Brazil

CON-21017, Linhares, Espirito SantoRecruiting

Linhares, Espírito Santo 29900-010, Brazil

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Salvador, Estado de Bahia 40050-410, Brazil

CON-21028, Brasilia, Distrito FederalRecruiting

Brasília, Federal District 70390-700, Brazil

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Aparecida de Goiânia, Goiás 74936-600, Brazil

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Goiânia, Goiás 74453-200, Brazil

CON-21020, Belo Horizonte, Minas GeraisRecruiting

Belo Horizonte, Minas Gerais 30180-080, Brazil

CON-21051, Belo Horizonte, Minas GeraisRecruiting

Belo Horizonte, Minas Gerais 30220-140, Brazil

CON-21013, Belo Horizonte, Minas GeraisRecruiting

Belo Horizonte, Minas Gerais 30441-070, Brazil

CON-21009, Poços de Caldas, Minas GeraisRecruiting

Poços de Caldas, Minas Gerais 37706, Brazil

CON-21056, Curitiba, ParanáRecruiting

Curitiba, Paraná 80060-900, Brazil

CON-21038, Curitiba, ParanáRecruiting

Curitiba, Paraná 80230-130, Brazil

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Londrina, Paraná 86038, Brazil

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Recife, Recife 50720-110, Brazil

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Rio de Janeiro, Rio de Janeiro 20551-030, Brazil

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Rio de Janeiro, Rio de Janeiro 22240-006, Brazil

CON-21024, Natal, Rio Grande do NorteRecruiting

Natal, Rio Grande do Norte 59020-500, Brazil

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

Caxias do Sul, Rio Grande do Sul 95070560, Brazil

CON-21042, Passo Fundo, Rio Grande do SulRecruiting

Passo Fundo, Rio Grande do Sul 99010, Brazil

CON-21007 Joinville, Santa Catarina Investigational SiteRecruiting

Joinville, Santa Catarina 89200-000, Brazil

CON-21058, Aracaju, SergipeRecruiting

Aracaju, Sergipe 49055-210, Brazil

CON-21057, Atibaia, São PauloRecruiting

Atibaia, São Paulo 12944-060, Brazil

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Bragança Paulista, São Paulo 12916542, Brazil

CON-21005, Itaquera, São PauloRecruiting

Itaquera, São Paulo 08270-120, Brazil

CON-21010, Osasco, São PauloRecruiting

Osasco, São Paulo 06013-070, Brazil

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Presidente Prudente, São Paulo 19050-680, Brazil

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Santo André, São Paulo 09090-790, Brazil

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São Paulo, São Paulo 01229-010, Brazil

CON-21062, São Paulo, São PauloRecruiting

São Paulo, São Paulo 01317-002, Brazil

CON-21037, São Paulo, São PauloRecruiting

São Paulo, São Paulo 01323-001, Brazil

CON-21048, São Paulo, São PauloRecruiting

São Paulo, São Paulo 04004-30, Brazil

CON-21049 Sao Paulo, Sao Paulo Investigational SiteRecruiting

São Paulo, São Paulo 05652-900, Brazil

CON-21031, Votuporanga, São PauloRecruiting

Votuporanga, São Paulo 15505-189, Brazil

CON-11011, Edmonton, ABRecruiting

Edmonton, Alberta T6G 2B7, Canada

CON-11012 Surry, BC Investigational SiteRecruiting

Surrey, British Columbia V3V OC6, Canada

CON-11016, Sudbury, ONRecruiting

Greater Sudbury, Ontario P3E 5J1, Canada

CON-11010, London, ONRecruiting

London, Ontario N6A 5A5, Canada

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North York, Ontario M6B 3H7, Canada

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Toronto, Ontario M4N 3M5, Canada

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Toronto, Ontario M5B 1W8, Canada

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Toronto, Ontario M5G 2C4, Canada

CON-11026, Montreal, QuebecRecruiting

Montreal, Quebec H2X 1R9, Canada

CON-11005 Sherbrooke, QC Investigational SiteRecruiting

Sherbrooke, Quebec J1H 5N4, Canada

CON-56002, Guangzhou, Guangdong provinceRecruiting

Guangzhou, Guangdong 510080, China

CON-56008, Changsha, HunanRecruiting

Changsha, Hunan 410011, China

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Jinan, Shandong 250001/250021, China

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Shanghai, Shanghai Municipality 200032, China

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Shanghai, Shanghai Municipality 200120, China

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Taiyuan, Shanxi 030027, China

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Xi’an, Shanxi 710038, China

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Chengdu, Sichuan 610072, China

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Tianjin, Tianjin Municipality 300052, China

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Hangzhou, Zhejiang 311200, China

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Ahmedabad, Gujarat 380005, India

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Bangalore, Karnataka 560002, India

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Nagpur, Maharashtra 440033, India

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Santiago de Compostela, Galicia 15706, Spain

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Madrid, Madrid 28034, Spain

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Madrid, Madrid 28046, Spain

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Málaga, Malaga 29010, Spain

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Manises, Valencia 46940, Spain

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Valencia, Valencia 46010, Spain

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Kandy, Central Province 2000, Sri Lanka

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Colombo, Western Province 01000, Sri Lanka

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Colombo, Western Province 10350, Sri Lanka

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Ragama, Western Province 11010, Sri Lanka

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Bournemouth, Dorset BH7 7DW, United Kingdom

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London, UK SW17 0QT, United Kingdom

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Bristol, BS10 5NB, United Kingdom

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Glasgow, G4 0SF, United Kingdom