Heart FailurePhase 3CONFIRMATIONNCT06024746
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)
A Phase 3 study testing Finerenone and Empagliflozin in people with Heart Failure, run by Colorado Prevention Center at 140 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Finerenone and Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 140 sitesin 8 countries
- Study dates
- 9 Jul 2024to Nov 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
140 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
140 sites in 8 countries
Brazil50 sites, 50 recruiting
- Recruiting
CON-21053, Aparecida de Goiânia, Goias
Aparecida de Goiânia, Goiás, 74936-600
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21058, Aracaju, Sergipe
Aracaju, Sergipe, 49055-210
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21064, Arapiraca, Alagoas, Brazil
Arapiraca, Alagoas, 57315-745
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21057, Atibaia, São Paulo
Atibaia, São Paulo, 12944-060
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21020, Belo Horizonte, Minas Gerais
Belo Horizonte, Minas Gerais, 30180-080
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21051, Belo Horizonte, Minas Gerais
Belo Horizonte, Minas Gerais, 30220-140
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Belo Horizonte, Minas Gerais Investigative Site CON-21079
Belo Horizonte, Minas Gerais, 30220-330
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21013, Belo Horizonte, Minas Gerais
Belo Horizonte, Minas Gerais, 30441-070
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21004 Braganca Paulista, Sao Paulo Investigational Site
Bragança Paulista, São Paulo, 12916542
- Recruiting
CON-21028, Brasilia, Distrito Federal
Brasília, Federal District, 70390-700
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Campinas, São Paulo Investigative Site CON-21083
Campinas, São Paulo, 13083-190
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21008, Caxias do Sul, Rio Grande do Sul
Caxias do Sul, Rio Grande do Sul, 95070560
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Curitiba, Parana Investigative Site CON-21029
Curitiba, Paraná, 80010-030
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21056, Curitiba, Paraná
Curitiba, Paraná, 80060-900
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21038, Curitiba, Paraná
Curitiba, Paraná, 80230-130
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Fortaleza, Ceará Investigative Site CON-21076
Fortaleza, Ceará, 60430275
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Fortaleza, Ceará Investigative Site CON-21055
Fortaleza, Ceará, 60864-190
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21003 Goiania, Goias Investigational Site
Goiânia, Goiás, 74453-200
- Recruiting
CON-21005, Itaquera, São Paulo
Itaquera, São Paulo, 08270-120
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21007 Joinville, Santa Catarina Investigational Site
Joinville, Santa Catarina, 89200-000
- Recruiting
CON-21017, Linhares, Espirito Santo
Linhares, Espírito Santo, 29900-010
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21047, Londrina, Paraná
Londrina, Paraná, 86038
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21024, Natal, Rio Grande do Norte
Natal, Rio Grande do Norte, 59020-500
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21010, Osasco, São Paulo
Osasco, São Paulo, 06013-070
+1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21042, Passo Fundo, Rio Grande do Sul
Passo Fundo, Rio Grande do Sul, 99010
+1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21009, Poços de Caldas, Minas Gerais
Poços de Caldas, Minas Gerais, 37706
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Porto Alegre, RS Investigative Site CON-21025
Porto Alegre, Rio Grande do Sul, 90630-165
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Porto Alegre, RS Investigative Site CON-21019
Porto Alegre, 90840-440
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Porto Velho, Rondonia Investigative Site CON-21087
Porto Velho, Rondônia, 76801-098
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21011, Presidente Prudente, São Paulo
Presidente Prudente, São Paulo, 19050-680
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Recife, Pernambuco Investigative Site CON-21021
Recife, Pernambuco, 50100-040
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Recife, Pernambuco Investigative Site CON-21086
Recife, Pernambuco, 51.110-160
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Recife, Pernambuco Investigative Site CON-21061
Recife, Pernambuco, 52010-075
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21001, Recife, Recife
Recife, Recife, 50720-110
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21036, Rio Branco, Acre
Rio Branco, Acre, 69915-030
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21016, Rio De Janeiro, Rio De Janeiro
Rio de Janeiro, Rio de Janeiro, 20551-030
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21014, Rio de Janeiro, Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 22240-006
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21032, Salvador, Bahia
Salvador, Estado de Bahia, 40050-410
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON021043, Santo André, São Paulo
Santo André, São Paulo, 09090-790
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
São Carlos, São Paulo Investigative Site CON-21075
São Carlos, São Paulo, 13566-448
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
São José dos Campos, São Paulo Investigative Site CON-21081
São José dos Campos, São Paulo, 12243000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21074, São Paulo, São Paulo
São Paulo, São Paulo, 01229-010
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21062, São Paulo, São Paulo
São Paulo, São Paulo, 01317-002
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21037, São Paulo, São Paulo
São Paulo, São Paulo, 01323-001
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21048, São Paulo, São Paulo
São Paulo, São Paulo, 04004-30
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21049 Sao Paulo, Sao Paulo Investigational Site
São Paulo, São Paulo, 05652-900
- Recruiting
São Paulo Investigative Site CON-21066
São Paulo, 05403-000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Teresina, Piaui Investigative Site CON-21050
Teresina, Piauí, 64001-450
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Vila Velha, Espírito Santo Investigative Site CON-21059
Vila Velha, Espírito Santo, 29118-060
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-21031, Votuporanga, São Paulo
Votuporanga, São Paulo, 15505-189
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
United States46 sites, 46 recruiting
- Recruiting
CON-10045 Amarillo, TX Investigational Site
Amarillo, Texas, 79106
- Recruiting
CON-10022 Atlanta, GA Investigational Site
Atlanta, Georgia, 30303
- Recruiting
CON-10001, Aurora, CO
Aurora, Colorado, 80045
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10015 Austin, TX Investigational Site
Austin, Texas, 78705
- Recruiting
CON-10030 Baton Rouge, LA Investigational Site
Baton Rouge, Louisiana, 70808
- Recruiting
Bradenton, FL Investigative Site CON-10125
Bradenton, Florida, 34209
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10119, Centerville, OH
Centerville, Ohio, 45459
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10318, Charlotte, NC
Charlotte, North Carolina, 28207
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10051, Chattanooga, TN
Chattanooga, Tennessee, 37403
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Chula Vista, CA Investigative Site CON-10111
Chula Vista, California, 91911
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10304, Denison, TX
Denison, Texas, 75020
Bonaca, MD, 3038609900, info@cpcmed.org
- Recruiting
CON-10005, Denver, CO
Denver, Colorado, 80204
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10075 El Centro, CA Investigational Site
El Centro, California, 92243
- Recruiting
CON-10004 Fairhope, AL Investigational Site
Fairhope, Alabama, 36532
- Recruiting
Fort Lauderdale, FL Investigative Site CON-10114
Fort Lauderdale, Florida, 33308
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10301, Fort Worth, TX
Fort Worth, Texas, 76104
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10021, Glenview, IL
Glenview, Illinois, 60026
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Greenville, NC Investigative Site CON-10122
Greenville, North Carolina, 27834
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10078, Hialeah, FL
Hialeah, Florida, 33012
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10085, Houston, TX
Houston, Texas, 77030
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Houston, TX Investigative Site CON-10320
Houston, Texas, 77058
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10041, Island Lake, IL
Island Lake, Illinois, 60042
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10002 Kansas City, MO Investigative Site
Kansas City, Missouri, 64111
Marc Bonaca
- Recruiting
CON-10305, Layton, UT
Layton, Utah, 84041
3038609900, info@cpcmed.org
- Recruiting
CON-10080, Lexington, KY
Lexington, Kentucky, 40503
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Lexington, KY Investigative Site CON-10118
Lexington, Kentucky, 40536
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10086, Louisville, Kentucky
Louisville, Kentucky, 40205
Bonaca, MD, 3038609900, info@cpcmed.org
- Recruiting
CON-10064, Merrillville, IN
Merrillville, Indiana, 46410
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10105, Miami, FL
Miami, Florida, 33135
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Minneapolis, MN Investigative Site CON-10035
Minneapolis, Minnesota, 55417
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10113, Miramar, FL
Miramar, Florida, 33027
Bonaca, MD, 3038609900, info@cpcmed.org
- Recruiting
Morrisville, NC Investigative Site CON-10317
Morrisville, North Carolina, 27560
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10025, Naperville, IL
Naperville, Illinois, 60540
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10009, Norfolk, VA
Norfolk, Virginia, 23507
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10018, Omaha, NE
Omaha, Nebraska, 68105
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10079, Paducah, KY
Paducah, Kentucky, 42003
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10019, Peoria, IL
Peoria, Illinois, 61603
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Philadelphia, PA Investigative Site CON-10068
Philadelphia, Pennsylvania, 19107
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Phoenix, AZ Investigative Site CON-10115
Phoenix, Arizona, 85006
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10024 Sacramento, CA Investigational Site
Sacramento, California, 95816
- Recruiting
Salem, VA Investigative Site CON-10048
Salem, Virginia, 24153
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
San Francisco, CA Investigative Site CON-10315
San Francisco, California, 94110
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10023, San Francisco, CA
San Francisco, California, 94118
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Texarkana, TX Investigative Site CON-10319
Texarkana, Texas, 75503
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10109, Van Nuys, CA
Van Nuys, California, 91405
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-10090, West Monroe, LA
West Monroe, Louisiana, 71291
Bonaca, MD, 3038609900, info@cpcmed.org
China11 sites, 11 recruiting
- Recruiting
CON-56008, Changsha, Hunan
Changsha, Hunan, 410011
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-56007, Chengdu City, Sichuan Province
Chengdu, Sichuan, 610072
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-56002, Guangzhou, Guangdong province
Guangzhou, Guangdong, 510080
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-56010, Hangzhou, Zhejiang Province
Hangzhou, Zhejiang, 311200
Bonaca, MD, 3038609900, info@cpcmed.org
- Recruiting
CON-56004, Jinan, Shandong Province
Jinan, Shandong, 250001/250021
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-56001, Shanghai, Shanghai
Shanghai, Shanghai Municipality, 200032
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-56009, Shanghai, Shanghai
Shanghai, Shanghai Municipality, 200120
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Shanghai, China Investigative Site CON-56011
Shanghai, 200072
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-56005, Taiyuan, Shanxi province
Taiyuan, Shanxi, 030027
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-56003, Tianjin, Tianjin
Tianjin, Tianjin Municipality, 300052
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-56006, Xi'an city, Shanxi Province
Xian City, Shanxi, 710038
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Canada10 sites, 10 recruiting
- Recruiting
CON-11011, Edmonton, AB
Edmonton, Alberta, T6G 2B7
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-11016, Sudbury, ON
Greater Sudbury, Ontario, P3E 5J1
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-11010, London, ON
London, Ontario, N6A 5A5
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-11026, Montreal, Quebec
Montreal, Quebec, H2X 1R9
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-11007 North York, ON Investigational Site
North York, Ontario, M6B 3H7
- Recruiting
CON-11005 Sherbrooke, QC Investigational Site
Sherbrooke, Quebec, J1H 5N4
- Recruiting
CON-11012 Surry, BC Investigational Site
Surrey, British Columbia, V3V OC6
- Recruiting
CON-11008, Toronto, ON
Toronto, Ontario, M4N 3M5
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-11019, Toronto, ON
Toronto, Ontario, M5B 1W8
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-11001, Toronto, ON
Toronto, Ontario, M5G 2C4
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Spain9 sites, 9 recruiting
- Recruiting
A Coruña, Galicia Investigative Site CON-38004
A Coruña, Galicia, 15006
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Barcelona Investigative Site CON-38010
Barcelona, 08907
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-38002, Madrid, Madrid
Madrid, Madrid, 28034
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-38011, Madrid, Madrid
Madrid, Madrid, 28046
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-38012, Malaga, Malaga
Málaga, Malaga, 29010
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-38009, Manises, Valencia
Manises, Valencia, 46940
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-38008, Santiago de Compostela, Galicia
Santiago de Compostela, Galicia, 15706
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-38001, Valencia, Valencia
Valencia, Valencia, 46010
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
Valencia Investigative Site CON-38007
Valencia, 46026
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
India5 sites, 5 recruiting
- Recruiting
CON-51006, Ahmedabad, Gujarat
Ahmedabad, Gujarat, 380005
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-51013, Bangalore, Karnataka
Bangalore, Karnataka, 560002
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-51009, Nagpur, Maharashtra
Nagpur, Maharashtra, 440033
Bonaca, MD, +1-303-860-9900
- Recruiting
New Delhi, Delhi Investigative Site CON-51011
New Delhi, National Capital Territory of Delhi, 110029
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
New Delhi, Delhi Investigative Site CON-51004
New Delhi, 110017
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
Sri Lanka5 sites, 5 recruiting
- Recruiting
Colombo, Western Province, Investigative Site CON-54006
Colombo, Western Province, 01000
Marc Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-54005, Colombo, Western Province
Colombo, Western Province, 01000
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-54007, Colombo, Western Province
Colombo, Western Province, 10350
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-54001, Kandy, Central Province
Kandy, Central Province, 2000
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-54008, Ragama, Western Province
Ragama, Western Province, 11010
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
United Kingdom4 sites, 4 recruiting
- Recruiting
CON-39010, Bournemouth, Dorset
Bournemouth, Dorset, BH7 7DW
Bonaca, MD, info@cpcmed.org
- Recruiting
CON-39007, Bristol, UK
Bristol, BS10 5NB
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-39001, Glasgow, UK
Glasgow, G4 0SF
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
- Recruiting
CON-39002, London, UK
London, UK, SW17 0QT
Bonaca, MD, +1-303-860-9900, info@cpcmed.org
About this study
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)
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.
Read the 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).
- Conditions
- Heart Failure
- Being tested
- Finerenone, Empagliflozin
- Keywords
- Heart Failure, Hospitalized
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Oral finerenone.
EmpagliflozinDrug
Oral empagliflozin.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone plus empagliflozin | Experimental | Not described Receives: Drug: Finerenone; Drug: Empagliflozin |
| Usual care | No intervention | Usual care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit
Hierarchical composite of the following:
- Time to all-cause mortality
- Number of total HF events
- Time to first HF event
- Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) assessed by the win-ratio method
Measured: 6 months
Number of serious adverse events (AEs).
- Serious AEs (excluding efficacy endpoints).
Measured: 6 months
Number of adverse events leading to discontinuation of study drug.
- AEs leading to discontinuation of finerenone or empagliflozin.
Measured: 6 months
Secondary outcomes (3)
Time to first death from any cause or HF event.
Time to first occurrence of all-cause mortality or HF event (hospitalization for HF or urgent visit due to HF)
Measured: 6 months
Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).
Measured: 6 months
Number of HF events from baseline to Day 90.
- Total (first and recurrent) HF events.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start9 Jul 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Prevention Center
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Luke's Mid America Heart Institute, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024746
- Sponsor's protocol ID
- 202303CPC
- Acronym
- CONFIRMATION
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share individual patient data with other researchers.