A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Last updated: February 19, 2026
Sponsor: Colorado Prevention Center
Overall Status: Active - Recruiting

Phase

3

Condition

Chest Pain

Heart Failure

Hyponatremia

Treatment

Placebo

Finerenone

Clinical Study ID

NCT06008197
202301CPC
  • Ages > 18
  • All Genders

Study Summary

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provide written informed consent

  • Age ≥18 years or legal age of majority if >18 years in the participant's country ofresidence

  • Current hospitalization or recently discharged (during or within 30 days ofdischarge) with the primary diagnosis of heart failure

  • Heart failure signs and symptoms at the time of hospital admission

  • Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)

  • Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-typenatriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF);or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF

Exclusion

Exclusion Criteria:

  • Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA)

  • Documented prior history of severe hyperkalemia in the setting of MRA use

  • Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or potassium >5.0mmol/L at screening

  • Acute myocardial infarction due to plaque rupture, coronary revascularization, valvereplacement/repair, or implantation of a cardiac resynchronization therapy devicewithin 30 days

  • Hemodynamically significant (severe) uncorrected primary cardiac valvular disease

  • Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases,accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes,known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, orknown 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)

Study Design

Total Participants: 5200
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 17, 2024
Estimated Completion Date:
December 31, 2027

Study Description

This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment of hospitalized heart failure patients with mildly reduced or preserved ejection fraction.

Connect with a study center

  • Córdoba, Córdoba Investigative Site 20014

    Córdoba 3860259, Córdoba Province 3860255 5003
    Argentina

    Active - Recruiting

  • Melbourne, VIC Investigative Site 50005

    Melbourne 2158177, Victoria 2145234 3121
    Australia

    Active - Recruiting

  • Fortaleza, Ceará Investigative Site 21055

    Fortaleza 3399415, Ceará I 60864-190
    Brazil

    Site Not Available

  • Salvador, Bahia Investigative Site 21032

    Salvador 3450554, Estado de Bahia 3471168 40050-410
    Brazil

    Active - Recruiting

  • Belo Horizonte, Minais Gerais Investigative Site 21013

    Belo Horizonte 3470127, Minais Gerais 30441-070
    Brazil

    Active - Recruiting

  • Belo Horizonte, Minas Gerais Investigative Site 21051

    Belo Horizonte 3470127, Minas Gerais 3457153 30220140
    Brazil

    Active - Recruiting

  • Curitiba, Paraná Investigative Site 21038

    Curitiba 3464975, Paraná 3455077 80230-130
    Brazil

    Active - Recruiting

  • Teresina, Piaui Investigative Site 21050

    Teresina 3386496, Piauí 3392213 64001-450
    Brazil

    Active - Recruiting

  • Recife, Recife Investigative Site 21001

    Recife 3390760, Recife 50720-110
    Brazil

    Active - Recruiting

  • Passo Fundo, Rio Grande do Sul Investigative Site 21042

    Passo Fundo 3454857, Rio Grande do Sul 3451133 99010 080
    Brazil

    Active - Recruiting

  • Porto Alegre, Rio Grande do Sul Investigative Site 21025

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90630-165
    Brazil

    Active - Recruiting

  • Rio De Janeiro, Rio De Janeiro Investigative Site 21016

    Rio de Janeiro 3451190, Rio de Janeiro 3451189 20551-030
    Brazil

    Active - Recruiting

  • Aracaju, Sergipe Investigative Site 21015

    Aracaju 3471872, Sergipe 3447799 49055-530
    Brazil

    Active - Recruiting

  • Aracaju, Sergipe Investigative Site 21058

    Aracaju 3471872, Sergipe 3447799 409055-000
    Brazil

    Active - Recruiting

  • Atibaia, São Paulo Investigative Site 21057

    Atibaia 3471335, São Paulo 3448433 12944-060
    Brazil

    Active - Recruiting

  • Santo André, Sao Paulo Investigative Site 21043

    Santo André 3449701, São Paulo 3448433 09090790
    Brazil

    Site Not Available

  • São José Dos Campos, Sao Paulo Investigative Site 21012

    São José dos Campos 3448636, São Paulo 3448433 12230-001
    Brazil

    Active - Recruiting

  • São Paulo, São Paulo Investigative Site 21035

    São Paulo 3448439, São Paulo 3448433 04696040
    Brazil

    Active - Recruiting

  • São Paulo, São Paulo Investigative Site 21041

    São Paulo 3448439, São Paulo 3448433 04550-000
    Brazil

    Active - Recruiting

  • São Paulo, São Paulo Investigative Site 21048

    São Paulo 3448439, São Paulo 3448433 04004-30
    Brazil

    Active - Recruiting

  • São Paulo, São Paulo Investigative Site 21049

    São Paulo 3448439, São Paulo 3448433 05652900
    Brazil

    Active - Recruiting

  • São Paulo, São Paulo Investigative Site 21062

    São Paulo 3448439, São Paulo 3448433 01317002
    Brazil

    Active - Recruiting

  • Edmonton, AB Investigative Site 11018

    Edmonton 5946768, Alberta 5883102 T5H 3V9
    Canada

    Active - Recruiting

  • Edmonton, Alberta Investigative Site 11011

    Edmonton 5946768, Alberta 5883102 T6G 2B7
    Canada

    Active - Recruiting

  • Kamloops, BC Investigative Site 11021

    Kamloops 5989045, British Columbia 5909050 V2C 2T1
    Canada

    Active - Recruiting

  • North Vancouver, BC Investigative Site11020

    North Vancouver 6090785, British Columbia 5909050 V7M2H4
    Canada

    Site Not Available

  • Surrey, British Columbia Investigative Site 11012

    Surrey 6159905, British Columbia 5909050 V3V 0C6
    Canada

    Active - Recruiting

  • Vancouver, BC Investigative Site 11017

    Vancouver 6173331, British Columbia 5909050 V6E 1M7
    Canada

    Active - Recruiting

  • Cambridge, ON Investigative Site 11003

    Cambridge 5913695, Ontario 6093943 N1R6V6
    Canada

    Active - Recruiting

  • Sudbury, ON Investigative Site 11016

    Greater Sudbury 5964700, Ontario 6093943 P3E 5J1
    Canada

    Active - Recruiting

  • North York, Ontario Investigative Site 11007

    North York, Ontario 6093943 M6B3H7
    Canada

    Active - Recruiting

  • Toronto, ON Investigative Site 11019

    Toronto 6167865, Ontario 6093943 M5B 1W8
    Canada

    Active - Recruiting

  • Toronto, Ontario Investigative Site 11008

    Toronto 6167865, Ontario 6093943 M4N3M5
    Canada

    Active - Recruiting

  • Regina, SK Investigative Site 11022

    Regina 6119109, Saskatchewan 6141242 S4P 0W5
    Canada

    Active - Recruiting

  • Zagreb, Grad Zagreb Investigative Site 30005

    Zagreb 3186886, Croatia 10000
    Croatia

    Active - Recruiting

  • Chlumec nad Cidlinou, Czech Republic Investigative Site 31005

    Chlumec nad Cidlinou 3077751, Czech Republic 30100
    Czechia

    Active - Recruiting

  • Plzeň, Czech Republic Investigative Site 31006

    Pilsen 3068160, Czech Republic 30100
    Czechia

    Active - Recruiting

  • Berlin, Berlin Investigative Site 32001

    Berlin 2950159, State of Berlin 2950157 13353
    Germany

    Active - Recruiting

  • Athens, Investigative Site 33007

    Athens 264371, Greece 14233
    Greece

    Active - Recruiting

  • Ahmedabad, Gujarat Investigative Site 51006

    Ahmedabad 1279233, Gujarat 1270770 380005
    India

    Active - Recruiting

  • Chennai, Tamil Nadu Investigative site 51008

    Chennai 1264527, Tamil Nadu 1255053 600 006
    India

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  • Varese, Varese Investigative Site 35004

    Varese 3164699, Varese 21100
    Italy

    Active - Recruiting

  • Alytus, Lithuania Investigative Site 36005

    Alytus 601084, Lithuania LT-62114
    Lithuania

    Active - Recruiting

  • Alor Setar, Kedah Investigative Site 52006

    Alor Star 1736309, Kedah 1733048 05460
    Malaysia

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  • Kuala Lumpur, Wilayah Persekutuan Investigative Site 52007

    Kuala Lumpur 1735161, Kuala Lumpur 1733046 50400
    Malaysia

    Active - Recruiting

  • Kuantan, Pahang Investigative Site 52004

    Kuantan 1735227, Pahang 1733042 25100
    Malaysia

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  • Kajang, Selangor Investigative Site 52008

    Kajang 10941913, Selangor 1733037 43000
    Malaysia

    Active - Recruiting

  • CULIACÁN, Flores Investigative Site 23002

    Culiacán 4012176, Flores 80230
    Mexico

    Site Not Available

  • Morelia, Michoacan Investigative Site 23007

    Morelia 3995402, Michoacán 3995955 58260
    Mexico

    Site Not Available

  • Culiacan, Sinaloa Investigative Site 23006

    Culiacán 4012176, Sinaloa 3983035 80020
    Mexico

    Active - Recruiting

  • Lima, Lima Investigative Site 24011

    Lima 3936456, Lima Province 3936451 15046
    Peru

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  • Seodaemun-gu, Seoul Investigative Site 53001

    Seoul 1835848, Seoul 1835847 03722
    South Korea

    Active - Recruiting

  • Santiago De Compostela, Galicia Investigative Site 38008

    Santiago de Compostela 3109642, Galicia 3336902 15706
    Spain

    Active - Recruiting

  • Barcelona, Spain Investigative Site 38010

    Barcelona 3128760, Spain 08907
    Spain

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  • Taipei, Taiwan Investigative Site 55008

    Taipei 1668341, Taiwan 7280291 106
    Taiwan

    Active - Recruiting

  • Glendale, AZ Investigative Site 10096

    Glendale 5295985, Arizona 5551752 85304
    United States

    Active - Recruiting

  • Huntington Beach, CA Investigative Site 10031

    Huntington Beach 5358705, California 5332921 92648
    United States

    Active - Recruiting

  • Los Angeles, CA Investigative Site 10089

    Los Angeles 5368361, California 5332921 90073
    United States

    Active - Recruiting

  • Aurora, CO Investigative Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Denver, CO Investigative Site

    Denver, Colorado 80204
    United States

    Site Not Available

  • Boca Raton, FL Investigative Site

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • Brooksville, FL Investigative Site 10077

    Brooksville 4148986, Florida 4155751 34613
    United States

    Active - Recruiting

  • Miramar, FL Investigative Site 10113

    Miramar 4164601, Florida 4155751 33027
    United States

    Site Not Available

  • Boise, Idaho Investigative Site 10073

    Boise 5586437, Idaho 5596512 83712
    United States

    Active - Recruiting

  • Chicago, IL Investigative Site 10062

    Chicago 4887398, Illinois 4896861 60612
    United States

    Active - Recruiting

  • Indianapolis, IN Investigative Site 10008

    Indianapolis 4259418, Indiana 4921868 46260
    United States

    Active - Recruiting

  • Indianapolis, IN Investigative Site 10074

    Indianapolis 4259418, Indiana 4921868 46237
    United States

    Active - Recruiting

  • Merrillville, IN Investigative Site 10064

    Merrillville 4923482, Indiana 4921868 46410
    United States

    Active - Recruiting

  • Louisville, KY Investigative Site 10006

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Active - Recruiting

  • Louisville, KY Investigative Site 10086

    Louisville 4299276, Kentucky 6254925 40205
    United States

    Site Not Available

  • Paducah, KY Investigative Site 10079

    Paducah 4048662, Kentucky 6254925 42003
    United States

    Active - Recruiting

  • Boston, MA Investigative Stie 10087

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Minneapolis, MN Investigative Site 10091

    Minneapolis 5037649, Minnesota 5037779 55407-1139
    United States

    Active - Recruiting

  • Tupelo, MS Investigative Site 10100

    Tupelo 4448903, Mississippi 4436296 38801
    United States

    Site Not Available

  • Kansas City, MO Investigative Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Stony Brook, NY Investigative Site 10017

    Stony Brook 5139865, New York 5128638 11794-8171
    United States

    Active - Recruiting

  • Centerville, OH Investigative Site 10119

    Centerville 4508204, Ohio 5165418 45459
    United States

    Active - Recruiting

  • Cincinnati, OH Investigative Site 10088

    Cincinnati 4508722, Ohio 5165418 45220
    United States

    Active - Recruiting

  • Bartlesville, OK Investigative Site 10095

    Bartlesville 4529987, Oklahoma 4544379 74006
    United States

    Active - Recruiting

  • Charleston, SC Investigative Site 10056

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • Memphis, TN Investigative Site 10059

    Memphis 4641239, Tennessee 4662168 38105
    United States

    Active - Recruiting

  • Burlington, VT Investigative Site 10053

    Burlington 5234372, Vermont 5242283 05401
    United States

    Active - Recruiting

  • Salem, VA Investigative Site 10048

    Salem 4784112, Virginia 6254928 24153
    United States

    Active - Recruiting

  • Milwaukee, WI Investigative Site 10061

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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