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A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)
NCT06024746 · Colorado Prevention Center
In plain English
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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)
About this study
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
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
Study design
Enrollment target: 1500 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-07-09
Estimated completion: 2027-11
Last updated: 2026-09-10
Interventions
Drug: FinerenoneDrug: Empagliflozin
Primary outcomes
- • Clinical benefit (6 months)
- • Number of serious adverse events (AEs). (6 months)
- • Number of adverse events leading to discontinuation of study drug. (6 months)
Sponsor
Colorado Prevention Center · other
With: Saint Luke's Mid America Heart Institute, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Contacts & investigators
ContactMarc Bonaca · contact · info@cpcmed.org · (303) 860-9900
All locations (140)
CON-10004 Fairhope, AL Investigational SiteRecruiting
Fairhope, Alabama, United States
Phoenix, AZ Investigative Site CON-10115Recruiting
Phoenix, Arizona, United States
Chula Vista, CA Investigative Site CON-10111Recruiting
Chula Vista, California, United States
CON-10075 El Centro, CA Investigational SiteRecruiting
El Centro, California, United States
CON-10024 Sacramento, CA Investigational SiteRecruiting
Sacramento, California, United States
San Francisco, CA Investigative Site CON-10315Recruiting
San Francisco, California, United States
CON-10023, San Francisco, CARecruiting
San Francisco, California, United States
CON-10109, Van Nuys, CARecruiting
Van Nuys, California, United States
CON-10001, Aurora, CORecruiting
Aurora, Colorado, United States
CON-10005, Denver, CORecruiting
Denver, Colorado, United States
Bradenton, FL Investigative Site CON-10125Recruiting
Bradenton, Florida, United States
Fort Lauderdale, FL Investigative Site CON-10114Recruiting
Fort Lauderdale, Florida, United States
CON-10078, Hialeah, FLRecruiting
Hialeah, Florida, United States
CON-10105, Miami, FLRecruiting
Miami, Florida, United States
CON-10113, Miramar, FLRecruiting
Miramar, Florida, United States
CON-10022 Atlanta, GA Investigational SiteRecruiting
Atlanta, Georgia, United States
CON-10021, Glenview, ILRecruiting
Glenview, Illinois, United States
CON-10041, Island Lake, ILRecruiting
Island Lake, Illinois, United States
CON-10025, Naperville, ILRecruiting
Naperville, Illinois, United States
CON-10019, Peoria, ILRecruiting
Peoria, Illinois, United States
CON-10064, Merrillville, INRecruiting
Merrillville, Indiana, United States
CON-10080, Lexington, KYRecruiting
Lexington, Kentucky, United States
Lexington, KY Investigative Site CON-10118Recruiting
Lexington, Kentucky, United States
CON-10086, Louisville, KentuckyRecruiting
Louisville, Kentucky, United States
CON-10079, Paducah, KYRecruiting
Paducah, Kentucky, United States
CON-10030 Baton Rouge, LA Investigational SiteRecruiting
Baton Rouge, Louisiana, United States
CON-10090, West Monroe, LARecruiting
West Monroe, Louisiana, United States
Minneapolis, MN Investigative Site CON-10035Recruiting
Minneapolis, Minnesota, United States
CON-10002 Kansas City, MO Investigative SiteRecruiting
Kansas City, Missouri, United States
CON-10018, Omaha, NERecruiting
Omaha, Nebraska, United States
CON-10318, Charlotte, NCRecruiting
Charlotte, North Carolina, United States
Greenville, NC Investigative Site CON-10122Recruiting
Greenville, North Carolina, United States
Morrisville, NC Investigative Site CON-10317Recruiting
Morrisville, North Carolina, United States
CON-10119, Centerville, OHRecruiting
Centerville, Ohio, United States
Philadelphia, PA Investigative Site CON-10068Recruiting
Philadelphia, Pennsylvania, United States
CON-10051, Chattanooga, TNRecruiting
Chattanooga, Tennessee, United States
CON-10045 Amarillo, TX Investigational SiteRecruiting
Amarillo, Texas, United States
CON-10015 Austin, TX Investigational SiteRecruiting
Austin, Texas, United States
CON-10304, Denison, TXRecruiting
Denison, Texas, United States
CON-10301, Fort Worth, TXRecruiting
Fort Worth, Texas, United States
CON-10085, Houston, TXRecruiting
Houston, Texas, United States
Houston, TX Investigative Site CON-10320Recruiting
Houston, Texas, United States
Texarkana, TX Investigative Site CON-10319Recruiting
Texarkana, Texas, United States
CON-10305, Layton, UTRecruiting
Layton, Utah, United States
CON-10009, Norfolk, VARecruiting
Norfolk, Virginia, United States
Salem, VA Investigative Site CON-10048Recruiting
Salem, Virginia, United States
CON-21036, Rio Branco, AcreRecruiting
Rio Branco, Acre, Brazil
CON-21064, Arapiraca, Alagoas, BrazilRecruiting
Arapiraca, Alagoas, Brazil
Fortaleza, Ceará Investigative Site CON-21076Recruiting
Fortaleza, Ceará, Brazil
Fortaleza, Ceará Investigative Site CON-21055Recruiting
Fortaleza, Ceará, Brazil
CON-21017, Linhares, Espirito SantoRecruiting
Linhares, Espírito Santo, Brazil
Vila Velha, Espírito Santo Investigative Site CON-21059Recruiting
Vila Velha, Espírito Santo, Brazil
CON-21032, Salvador, BahiaRecruiting
Salvador, Estado de Bahia, Brazil
CON-21028, Brasilia, Distrito FederalRecruiting
Brasília, Federal District, Brazil
CON-21053, Aparecida de Goiânia, GoiasRecruiting
Aparecida de Goiânia, Goiás, Brazil
CON-21003 Goiania, Goias Investigational SiteRecruiting
Goiânia, Goiás, Brazil
CON-21020, Belo Horizonte, Minas GeraisRecruiting
Belo Horizonte, Minas Gerais, Brazil
CON-21051, Belo Horizonte, Minas GeraisRecruiting
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais Investigative Site CON-21079Recruiting
Belo Horizonte, Minas Gerais, Brazil
CON-21013, Belo Horizonte, Minas GeraisRecruiting
Belo Horizonte, Minas Gerais, Brazil
CON-21009, Poços de Caldas, Minas GeraisRecruiting
Poços de Caldas, Minas Gerais, Brazil
Curitiba, Parana Investigative Site CON-21029Recruiting
Curitiba, Paraná, Brazil
CON-21056, Curitiba, ParanáRecruiting
Curitiba, Paraná, Brazil
CON-21038, Curitiba, ParanáRecruiting
Curitiba, Paraná, Brazil
CON-21047, Londrina, ParanáRecruiting
Londrina, Paraná, Brazil
Recife, Pernambuco Investigative Site CON-21021Recruiting
Recife, Pernambuco, Brazil
Recife, Pernambuco Investigative Site CON-21086Recruiting
Recife, Pernambuco, Brazil
Recife, Pernambuco Investigative Site CON-21061Recruiting
Recife, Pernambuco, Brazil
Teresina, Piaui Investigative Site CON-21050Recruiting
Teresina, Piauí, Brazil
CON-21001, Recife, RecifeRecruiting
Recife, Recife, Brazil
CON-21016, Rio De Janeiro, Rio De JaneiroRecruiting
Rio de Janeiro, Rio de Janeiro, Brazil
CON-21014, Rio de Janeiro, Rio de JaneiroRecruiting
Rio de Janeiro, Rio de Janeiro, Brazil
CON-21024, Natal, Rio Grande do NorteRecruiting
Natal, Rio Grande do Norte, Brazil
CON-21008, Caxias do Sul, Rio Grande do SulRecruiting
Caxias do Sul, Rio Grande do Sul, Brazil
CON-21042, Passo Fundo, Rio Grande do SulRecruiting
Passo Fundo, Rio Grande do Sul, Brazil
Porto Alegre, RS Investigative Site CON-21025Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Porto Velho, Rondonia Investigative Site CON-21087Recruiting
Porto Velho, Rondônia, Brazil
CON-21007 Joinville, Santa Catarina Investigational SiteRecruiting
Joinville, Santa Catarina, Brazil
CON-21058, Aracaju, SergipeRecruiting
Aracaju, Sergipe, Brazil
CON-21057, Atibaia, São PauloRecruiting
Atibaia, São Paulo, Brazil
CON-21004 Braganca Paulista, Sao Paulo Investigational SiteRecruiting
Bragança Paulista, São Paulo, Brazil
Campinas, São Paulo Investigative Site CON-21083Recruiting
Campinas, São Paulo, Brazil
CON-21005, Itaquera, São PauloRecruiting
Itaquera, São Paulo, Brazil
CON-21010, Osasco, São PauloRecruiting
Osasco, São Paulo, Brazil
CON-21011, Presidente Prudente, São PauloRecruiting
Presidente Prudente, São Paulo, Brazil
CON021043, Santo André, São PauloRecruiting
Santo André, São Paulo, Brazil
São Carlos, São Paulo Investigative Site CON-21075Recruiting
São Carlos, São Paulo, Brazil
São José dos Campos, São Paulo Investigative Site CON-21081Recruiting
São José dos Campos, São Paulo, Brazil
CON-21074, São Paulo, São PauloRecruiting
São Paulo, São Paulo, Brazil
CON-21062, São Paulo, São PauloRecruiting
São Paulo, São Paulo, Brazil
CON-21037, São Paulo, São PauloRecruiting
São Paulo, São Paulo, Brazil
CON-21048, São Paulo, São PauloRecruiting
São Paulo, São Paulo, Brazil
CON-21049 Sao Paulo, Sao Paulo Investigational SiteRecruiting
São Paulo, São Paulo, Brazil
CON-21031, Votuporanga, São PauloRecruiting
Votuporanga, São Paulo, Brazil
Porto Alegre, RS Investigative Site CON-21019Recruiting
Porto Alegre, Brazil
São Paulo Investigative Site CON-21066Recruiting
São Paulo, Brazil
CON-11011, Edmonton, ABRecruiting
Edmonton, Alberta, Canada
CON-11012 Surry, BC Investigational SiteRecruiting
Surrey, British Columbia, Canada
CON-11016, Sudbury, ONRecruiting
Greater Sudbury, Ontario, Canada
CON-11010, London, ONRecruiting
London, Ontario, Canada
CON-11007 North York, ON Investigational SiteRecruiting
North York, Ontario, Canada
CON-11008, Toronto, ONRecruiting
Toronto, Ontario, Canada
CON-11019, Toronto, ONRecruiting
Toronto, Ontario, Canada
CON-11001, Toronto, ONRecruiting
Toronto, Ontario, Canada
CON-11026, Montreal, QuebecRecruiting
Montreal, Quebec, Canada
CON-11005 Sherbrooke, QC Investigational SiteRecruiting
Sherbrooke, Quebec, Canada
CON-56002, Guangzhou, Guangdong provinceRecruiting
Guangzhou, Guangdong, China
CON-56008, Changsha, HunanRecruiting
Changsha, Hunan, China
CON-56004, Jinan, Shandong ProvinceRecruiting
Jinan, Shandong, China
CON-56001, Shanghai, ShanghaiRecruiting
Shanghai, Shanghai Municipality, China
CON-56009, Shanghai, ShanghaiRecruiting
Shanghai, Shanghai Municipality, China
CON-56005, Taiyuan, Shanxi provinceRecruiting
Taiyuan, Shanxi, China
CON-56006, Xi'an city, Shanxi ProvinceRecruiting
Xian City, Shanxi, China
CON-56007, Chengdu City, Sichuan ProvinceRecruiting
Chengdu, Sichuan, China
CON-56003, Tianjin, TianjinRecruiting
Tianjin, Tianjin Municipality, China
CON-56010, Hangzhou, Zhejiang ProvinceRecruiting
Hangzhou, Zhejiang, China
Shanghai, China Investigative Site CON-56011Recruiting
Shanghai, China
CON-51006, Ahmedabad, GujaratRecruiting
Ahmedabad, Gujarat, India
CON-51013, Bangalore, KarnatakaRecruiting
Bangalore, Karnataka, India
CON-51009, Nagpur, MaharashtraRecruiting
Nagpur, Maharashtra, India
New Delhi, Delhi Investigative Site CON-51011Recruiting
New Delhi, National Capital Territory of Delhi, India
New Delhi, Delhi Investigative Site CON-51004Recruiting
New Delhi, India
A Coruña, Galicia Investigative Site CON-38004Recruiting
A Coruña, Galicia, Spain
CON-38008, Santiago de Compostela, GaliciaRecruiting
Santiago de Compostela, Galicia, Spain
CON-38002, Madrid, MadridRecruiting
Madrid, Madrid, Spain
CON-38011, Madrid, MadridRecruiting
Madrid, Madrid, Spain
CON-38012, Malaga, MalagaRecruiting
Málaga, Malaga, Spain
CON-38009, Manises, ValenciaRecruiting
Manises, Valencia, Spain
CON-38001, Valencia, ValenciaRecruiting
Valencia, Valencia, Spain
Barcelona Investigative Site CON-38010Recruiting
Barcelona, Spain
Valencia Investigative Site CON-38007Recruiting
Valencia, Spain
CON-54001, Kandy, Central ProvinceRecruiting
Kandy, Central Province, Sri Lanka
Colombo, Western Province, Investigative Site CON-54006Recruiting
Colombo, Western Province, Sri Lanka
CON-54005, Colombo, Western ProvinceRecruiting
Colombo, Western Province, Sri Lanka
CON-54007, Colombo, Western ProvinceRecruiting
Colombo, Western Province, Sri Lanka
CON-54008, Ragama, Western ProvinceRecruiting
Ragama, Western Province, Sri Lanka
CON-39010, Bournemouth, DorsetRecruiting
Bournemouth, Dorset, United Kingdom
CON-39002, London, UKRecruiting
London, UK, United Kingdom
CON-39007, Bristol, UKRecruiting
Bristol, United Kingdom
CON-39001, Glasgow, UKRecruiting
Glasgow, United Kingdom