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

September 8, 2026 updated by: Colorado Prevention Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Porto Alegre, Brazil, 90840-440
        • Recruiting
        • Porto Alegre, RS Investigative Site CON-21019
        • Contact:
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • São Paulo Investigative Site CON-21066
        • Contact:
    • Acre
      • Rio Branco, Acre, Brazil, 69915-030
        • Recruiting
        • CON-21036, Rio Branco, Acre
        • Contact:
    • Alagoas
      • Arapiraca, Alagoas, Brazil, 57315-745
        • Recruiting
        • CON-21064, Arapiraca, Alagoas, Brazil
        • Contact:
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430275
        • Recruiting
        • Fortaleza, Ceará Investigative Site CON-21076
        • Contact:
      • Fortaleza, Ceará, Brazil, 60864-190
        • Recruiting
        • Fortaleza, Ceará Investigative Site CON-21055
        • Contact:
    • Espírito Santo
      • Linhares, Espírito Santo, Brazil, 29900-010
        • Recruiting
        • CON-21017, Linhares, Espirito Santo
        • Contact:
      • Vila Velha, Espírito Santo, Brazil, 29118-060
        • Recruiting
        • Vila Velha, Espírito Santo Investigative Site CON-21059
        • Contact:
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40050-410
        • Recruiting
        • CON-21032, Salvador, Bahia
        • Contact:
    • Federal District
      • Brasília, Federal District, Brazil, 70390-700
        • Recruiting
        • CON-21028, Brasilia, Distrito Federal
        • Contact:
    • Goiás
      • Aparecida de Goiânia, Goiás, Brazil, 74936-600
        • Recruiting
        • CON-21053, Aparecida de Goiânia, Goias
        • Contact:
      • Goiânia, Goiás, Brazil, 74453-200
        • Recruiting
        • CON-21003 Goiania, Goias Investigational Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30180-080
        • Recruiting
        • CON-21020, Belo Horizonte, Minas Gerais
        • Contact:
      • Belo Horizonte, Minas Gerais, Brazil, 30220-140
        • Recruiting
        • CON-21051, Belo Horizonte, Minas Gerais
        • Contact:
      • Belo Horizonte, Minas Gerais, Brazil, 30441-070
        • Recruiting
        • CON-21013, Belo Horizonte, Minas Gerais
        • Contact:
      • Belo Horizonte, Minas Gerais, Brazil, 30220-330
        • Recruiting
        • Belo Horizonte, Minas Gerais Investigative Site CON-21079
        • Contact:
      • Poços de Caldas, Minas Gerais, Brazil, 37706
        • Recruiting
        • CON-21009, Poços de Caldas, Minas Gerais
        • Contact:
    • Paraná
      • Curitiba, Paraná, Brazil, 80060-900
        • Recruiting
        • CON-21056, Curitiba, Paraná
        • Contact:
      • Curitiba, Paraná, Brazil, 80230-130
        • Recruiting
        • CON-21038, Curitiba, Paraná
        • Contact:
      • Curitiba, Paraná, Brazil, 80010-030
        • Recruiting
        • Curitiba, Parana Investigative Site CON-21029
        • Contact:
      • Londrina, Paraná, Brazil, 86038
        • Recruiting
        • CON-21047, Londrina, Paraná
        • Contact:
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50100-040
        • Recruiting
        • Recife, Pernambuco Investigative Site CON-21021
        • Contact:
      • Recife, Pernambuco, Brazil, 51.110-160
        • Recruiting
        • Recife, Pernambuco Investigative Site CON-21086
        • Contact:
      • Recife, Pernambuco, Brazil, 52010-075
        • Recruiting
        • Recife, Pernambuco Investigative Site CON-21061
        • Contact:
    • Piauí
      • Teresina, Piauí, Brazil, 64001-450
        • Recruiting
        • Teresina, Piaui Investigative Site CON-21050
        • Contact:
    • Recife
      • Recife, Recife, Brazil, 50720-110
        • Recruiting
        • CON-21001, Recife, Recife
        • Contact:
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59020-500
        • Recruiting
        • CON-21024, Natal, Rio Grande do Norte
        • Contact:
    • Rio Grande do Sul
      • Caxias do Sul, Rio Grande do Sul, Brazil, 95070560
        • Recruiting
        • CON-21008, Caxias do Sul, Rio Grande do Sul
        • Contact:
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010
        • Recruiting
        • CON-21042, Passo Fundo, Rio Grande do Sul
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brazil, 90630-165
        • Recruiting
        • Porto Alegre, RS Investigative Site CON-21025
        • Contact:
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
        • Recruiting
        • CON-21016, Rio De Janeiro, Rio De Janeiro
        • Contact:
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22240-006
        • Recruiting
        • CON-21014, Rio de Janeiro, Rio de Janeiro
        • Contact:
    • Rondônia
      • Porto Velho, Rondônia, Brazil, 76801-098
        • Recruiting
        • Porto Velho, Rondonia Investigative Site CON-21087
        • Contact:
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89200-000
        • Recruiting
        • CON-21007 Joinville, Santa Catarina Investigational Site
    • Sergipe
      • Aracaju, Sergipe, Brazil, 49055-210
        • Recruiting
        • CON-21058, Aracaju, Sergipe
        • Contact:
    • São Paulo
      • Atibaia, São Paulo, Brazil, 12944-060
        • Recruiting
        • CON-21057, Atibaia, São Paulo
        • Contact:
      • Bragança Paulista, São Paulo, Brazil, 12916542
        • Recruiting
        • CON-21004 Braganca Paulista, Sao Paulo Investigational Site
      • Campinas, São Paulo, Brazil, 13083-190
        • Recruiting
        • Campinas, São Paulo Investigative Site CON-21083
        • Contact:
      • Itaquera, São Paulo, Brazil, 08270-120
        • Recruiting
        • CON-21005, Itaquera, São Paulo
        • Contact:
      • Osasco, São Paulo, Brazil, 06013-070
        • Recruiting
        • CON-21010, Osasco, São Paulo
        • Contact:
      • Presidente Prudente, São Paulo, Brazil, 19050-680
        • Recruiting
        • CON-21011, Presidente Prudente, São Paulo
        • Contact:
      • Santo André, São Paulo, Brazil, 09090-790
        • Recruiting
        • CON021043, Santo André, São Paulo
        • Contact:
      • São Carlos, São Paulo, Brazil, 13566-448
        • Recruiting
        • São Carlos, São Paulo Investigative Site CON-21075
        • Contact:
      • São José dos Campos, São Paulo, Brazil, 12243000
        • Recruiting
        • São José dos Campos, São Paulo Investigative Site CON-21081
        • Contact:
      • São Paulo, São Paulo, Brazil, 01229-010
        • Recruiting
        • CON-21074, São Paulo, São Paulo
        • Contact:
      • São Paulo, São Paulo, Brazil, 01317-002
        • Recruiting
        • CON-21062, São Paulo, São Paulo
        • Contact:
      • São Paulo, São Paulo, Brazil, 01323-001
        • Recruiting
        • CON-21037, São Paulo, São Paulo
        • Contact:
      • São Paulo, São Paulo, Brazil, 04004-30
        • Recruiting
        • CON-21048, São Paulo, São Paulo
        • Contact:
      • São Paulo, São Paulo, Brazil, 05652-900
        • Recruiting
        • CON-21049 Sao Paulo, Sao Paulo Investigational Site
      • Votuporanga, São Paulo, Brazil, 15505-189
        • Recruiting
        • CON-21031, Votuporanga, São Paulo
        • Contact:
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • CON-11011, Edmonton, AB
        • Contact:
    • British Columbia
      • Surrey, British Columbia, Canada, V3V OC6
        • Recruiting
        • CON-11012 Surry, BC Investigational Site
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Recruiting
        • CON-11016, Sudbury, ON
        • Contact:
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • CON-11010, London, ON
        • Contact:
      • North York, Ontario, Canada, M6B 3H7
        • Recruiting
        • CON-11007 North York, ON Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • CON-11008, Toronto, ON
        • Contact:
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • CON-11019, Toronto, ON
        • Contact:
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • CON-11001, Toronto, ON
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H2X 1R9
        • Recruiting
        • CON-11026, Montreal, Quebec
        • Contact:
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • CON-11005 Sherbrooke, QC Investigational Site
  • China
      • Shanghai, China, 200072
        • Recruiting
        • Shanghai, China Investigative Site CON-56011
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • CON-56002, Guangzhou, Guangdong province
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • CON-56008, Changsha, Hunan
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250001/250021
        • Recruiting
        • CON-56004, Jinan, Shandong Province
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • CON-56001, Shanghai, Shanghai
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200120
        • Recruiting
        • CON-56009, Shanghai, Shanghai
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030027
        • Recruiting
        • CON-56005, Taiyuan, Shanxi province
        • Contact:
      • Xian City, Shanxi, China, 710038
        • Recruiting
        • CON-56006, Xi'an city, Shanxi Province
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • CON-56007, Chengdu City, Sichuan Province
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Recruiting
        • CON-56003, Tianjin, Tianjin
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 311200
        • Recruiting
        • CON-56010, Hangzhou, Zhejiang Province
        • Contact:
  • India
      • New Delhi, India, 110017
        • Recruiting
        • New Delhi, Delhi Investigative Site CON-51004
        • Contact:
    • Gujarat
      • Ahmedabad, Gujarat, India, 380005
        • Recruiting
        • CON-51006, Ahmedabad, Gujarat
        • Contact:
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Recruiting
        • CON-51013, Bangalore, Karnataka
        • Contact:
    • Maharashtra
      • Nagpur, Maharashtra, India, 440033
        • Recruiting
        • CON-51009, Nagpur, Maharashtra
        • Contact:
          • Bonaca, MD
          • Phone Number: +1-303-860-9900
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Recruiting
        • New Delhi, Delhi Investigative Site CON-51011
        • Contact:
  • Spain
      • Barcelona, Spain, 08907
        • Recruiting
        • Barcelona Investigative Site CON-38010
        • Contact:
      • Valencia, Spain, 46026
        • Recruiting
        • Valencia Investigative Site CON-38007
        • Contact:
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Recruiting
        • A Coruña, Galicia Investigative Site CON-38004
        • Contact:
      • Santiago de Compostela, Galicia, Spain, 15706
        • Recruiting
        • CON-38008, Santiago de Compostela, Galicia
        • Contact:
    • Madrid
      • Madrid, Madrid, Spain, 28034
        • Recruiting
        • CON-38002, Madrid, Madrid
        • Contact:
      • Madrid, Madrid, Spain, 28046
        • Recruiting
        • CON-38011, Madrid, Madrid
        • Contact:
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Recruiting
        • CON-38012, Malaga, Malaga
        • Contact:
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Recruiting
        • CON-38009, Manises, Valencia
        • Contact:
      • Valencia, Valencia, Spain, 46010
        • Recruiting
        • CON-38001, Valencia, Valencia
        • Contact:
  • Sri Lanka
    • Central Province
      • Kandy, Central Province, Sri Lanka, 2000
        • Recruiting
        • CON-54001, Kandy, Central Province
        • Contact:
    • Western Province
      • Colombo, Western Province, Sri Lanka, 01000
        • Recruiting
        • CON-54005, Colombo, Western Province
        • Contact:
      • Colombo, Western Province, Sri Lanka, 10350
        • Recruiting
        • CON-54007, Colombo, Western Province
        • Contact:
      • Colombo, Western Province, Sri Lanka, 01000
        • Recruiting
        • Colombo, Western Province, Investigative Site CON-54006
        • Contact:
      • Ragama, Western Province, Sri Lanka, 11010
        • Recruiting
        • CON-54008, Ragama, Western Province
        • Contact:
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • Recruiting
        • CON-39007, Bristol, UK
        • Contact:
      • Glasgow, United Kingdom, G4 0SF
        • Recruiting
        • CON-39001, Glasgow, UK
        • Contact:
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Recruiting
        • CON-39010, Bournemouth, Dorset
        • Contact:
    • UK
      • London, UK, United Kingdom, SW17 0QT
        • Recruiting
        • CON-39002, London, UK
        • Contact:
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Recruiting
        • CON-10004 Fairhope, AL Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Phoenix, AZ Investigative Site CON-10115
        • Contact:
    • California
      • Chula Vista, California, United States, 91911
        • Recruiting
        • Chula Vista, CA Investigative Site CON-10111
        • Contact:
      • El Centro, California, United States, 92243
        • Recruiting
        • CON-10075 El Centro, CA Investigational Site
      • Sacramento, California, United States, 95816
        • Recruiting
        • CON-10024 Sacramento, CA Investigational Site
      • San Francisco, California, United States, 94118
        • Recruiting
        • CON-10023, San Francisco, CA
        • Contact:
      • San Francisco, California, United States, 94110
        • Recruiting
        • San Francisco, CA Investigative Site CON-10315
        • Contact:
      • Van Nuys, California, United States, 91405
        • Recruiting
        • CON-10109, Van Nuys, CA
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • CON-10001, Aurora, CO
        • Contact:
      • Denver, Colorado, United States, 80204
        • Recruiting
        • CON-10005, Denver, CO
        • Contact:
    • Florida
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Bradenton, FL Investigative Site CON-10125
        • Contact:
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Fort Lauderdale, FL Investigative Site CON-10114
        • Contact:
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • CON-10078, Hialeah, FL
        • Contact:
      • Miami, Florida, United States, 33135
        • Recruiting
        • CON-10105, Miami, FL
        • Contact:
      • Miramar, Florida, United States, 33027
        • Recruiting
        • CON-10113, Miramar, FL
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • CON-10022 Atlanta, GA Investigational Site
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • CON-10021, Glenview, IL
        • Contact:
      • Island Lake, Illinois, United States, 60042
        • Recruiting
        • CON-10041, Island Lake, IL
        • Contact:
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • CON-10025, Naperville, IL
        • Contact:
      • Peoria, Illinois, United States, 61603
        • Recruiting
        • CON-10019, Peoria, IL
        • Contact:
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Recruiting
        • CON-10064, Merrillville, IN
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • CON-10080, Lexington, KY
        • Contact:
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • Lexington, KY Investigative Site CON-10118
        • Contact:
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • CON-10086, Louisville, Kentucky
        • Contact:
      • Paducah, Kentucky, United States, 42003
        • Recruiting
        • CON-10079, Paducah, KY
        • Contact:
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • CON-10030 Baton Rouge, LA Investigational Site
      • West Monroe, Louisiana, United States, 71291
        • Recruiting
        • CON-10090, West Monroe, LA
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Recruiting
        • Minneapolis, MN Investigative Site CON-10035
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • CON-10002 Kansas City, MO Investigative Site
        • Contact:
          • Marc Bonaca
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Recruiting
        • CON-10018, Omaha, NE
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • CON-10318, Charlotte, NC
        • Contact:
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Greenville, NC Investigative Site CON-10122
        • Contact:
      • Morrisville, North Carolina, United States, 27560
        • Recruiting
        • Morrisville, NC Investigative Site CON-10317
        • Contact:
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • CON-10119, Centerville, OH
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Philadelphia, PA Investigative Site CON-10068
        • Contact:
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Recruiting
        • CON-10051, Chattanooga, TN
        • Contact:
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • CON-10045 Amarillo, TX Investigational Site
      • Austin, Texas, United States, 78705
        • Recruiting
        • CON-10015 Austin, TX Investigational Site
      • Denison, Texas, United States, 75020
        • Recruiting
        • CON-10304, Denison, TX
        • Contact:
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • CON-10301, Fort Worth, TX
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • CON-10085, Houston, TX
        • Contact:
      • Houston, Texas, United States, 77058
        • Recruiting
        • Houston, TX Investigative Site CON-10320
        • Contact:
      • Texarkana, Texas, United States, 75503
        • Recruiting
        • Texarkana, TX Investigative Site CON-10319
        • Contact:
    • Utah
      • Layton, Utah, United States, 84041
        • Recruiting
        • CON-10305, Layton, UT
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • CON-10009, Norfolk, VA
        • Contact:
      • Salem, Virginia, United States, 24153
        • Recruiting
        • Salem, VA Investigative Site CON-10048
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Finerenone plus empagliflozin
Drug: Finerenone
Oral finerenone.
Drug: Empagliflozin
Oral empagliflozin.
No Intervention: Usual care
Usual care management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of serious adverse events (AEs).
Time Frame: 6 months
- Serious AEs (excluding efficacy endpoints).
6 months
Number of adverse events leading to discontinuation of study drug.
Time Frame: 6 months
- AEs leading to discontinuation of finerenone or empagliflozin.
6 months
Clinical benefit
Time Frame: 6 months

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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first death from any cause or HF event.
Time Frame: 6 months
Time to first occurrence of all-cause mortality or HF event (hospitalization for HF or urgent visit due to HF)
6 months
Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).
Time Frame: 6 months
6 months
Number of HF events from baseline to Day 90.
Time Frame: 90 days
- Total (first and recurrent) HF events.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado Prevention Center

Collaborators

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Saint Luke's Mid America Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202303CPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plan to share individual patient data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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