Recruiting
Phase 3

Finerenone

Sponsor:

Colorado Prevention Center

Code:

NCT06008197

Conditions

Heart Failure

Acute Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Finerenone

Placebo

Study Details

Brief 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.

Conditions

Heart Failure

Acute Heart Failure

Study ID

NCT06008197

Start date

Jan 17, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provide written informed consent
  • Age ≥18 years or legal age of majority if >18 years in the participant's country of residence
  • Current hospitalization or recently discharged (during or within 30 days of discharge) 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-type natriuretic 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 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 >5.0 mmol/L at screening
  • Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 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, or known 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

Enrollment

5200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Finerenone

placebo comparator: Placebo

Interventions

Finerenone

Oral finerenone

Placebo

Matching oral placebo

Primary outcome measure

  • Composite of total HF events and cardiovascular (CV) death. [ Time Frame: Ongoing, up to ~30 months ]
  • Number of serious adverse events. [ Time Frame: Ongoing, up to ~30 months ]
  • Number of adverse events leading to discontinuation of study drug. [ Time Frame: Ongoing, up to ~30 months ]

Central Contacts and Locations

Central contacts

Locations

Birmingham, AL Investigative Site 10012

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Fairhope, AL Investigative Site 10004

Recruiting

Fairhope, Alabama, United States, 36532

Contacts

Huntsville, AL Investigative Site 10026

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Glendale, AZ Investigative Site 10096

Recruiting

Glendale, Arizona, United States, 85304

Contacts

Phoenix, AZ Investigative Site 10115

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Scottsdale, AZ Investigative Site 10003

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Chula Vista, CA Investigative Site 10111

Recruiting

Chula Vista, California, United States, 91911

Contacts

Huntington Beach, CA Investigative Site 10031

Recruiting

Huntington Beach, California, United States, 92648

Contacts

Los Angeles, CA Investigative Site 10089

Recruiting

Los Angeles, California, United States, 90073

Contacts

Sacramento, CA Investigative Site 10024

Recruiting

Sacramento, California, United States, 95816

Contacts

San Francisco, CA Investigative Site 10023

Recruiting

San Francisco, California, United States, 94118

Contacts

Tarzana, CA Investigative Site 10409

Recruiting

Tarzana, California, United States, 91356

Contacts

Van Nuys, CA Investigative Site 10109

Recruiting

Van Nuys, California, United States, 91405

Contacts

West Hills, CA Investigative Site 10013

Recruiting

West Hills, California, United States, 91307

Contacts

Aurora, CO Investigative Site 10001

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Denver, CO Investigative Site 10005

Recruiting

Denver, Colorado, United States, 80204

Contacts

Bradenton, FL Investigative Site 10125

Recruiting

Bradenton, Florida, United States, 34209

Contacts

Brooksville, FL Investigative Site 10077

Recruiting

Brooksville, Florida, United States, 34613

Contacts

Fort Lauderdale, FL Investigative Site 10114

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

Fort Myers, FL Investigative Site 10076

Recruiting

Fort Myers, Florida, United States, 33919

Contacts

Hialeah, FL Investigative Site 10104

Recruiting

Hialeah, Florida, United States, 33012

Contacts

Jacksonville, FL Investigative Site 10028

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Miami, FL Investigative Site 10105

Recruiting

Miami, Florida, United States, 33135

Contacts

Miami, FL Investigative Site 10040

Recruiting

Miami, Florida, United States, 33173

Contacts

Atlanta, GA Investigative Site 10022

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Duluth, GA Investigative Site 10083

Recruiting

Duluth, Georgia, United States, 30096

Contacts

Boise, Idaho Investigative Site 10073

Recruiting

Boise, Idaho, United States, 83712

Contacts

Chicago, IL Investigative Site 10062

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Glenview, IL Investigative Site 10021

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Naperville, IL Investigative Site 10025

Recruiting

Naperville, Illinois, United States, 60540

Contacts

Peoria, IL Investigative Site 10019

Recruiting

Peoria, Illinois, United States, 61603

Contacts

Peoria, IL Investigative Site 10010

Recruiting

Peoria, Illinois, United States, 61614

Contacts

Indianapolis, IN Investigative Site 10074

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

Indianapolis, IN Investigative Site 10008

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Merrillville, IN Investigative Site 10064

Recruiting

Merrillville, Indiana, United States, 46410

Contacts

Kansas City, KS Investigative Site 10060

Recruiting

Kansas City, Kansas, United States, 66103

Contacts

Cynthiana, KY Investigative Site 10124

Recruiting

Cynthiana, Kentucky, United States, 41031

Contacts

Lexington, KY Investigative Site 10080

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Lexington, KY Investigative Site 10118

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Louisville, KY Investigative Site 10006

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Paducah, KY Investigative Site 10079

Recruiting

Paducah, Kentucky, United States, 42003

Contacts

Baton Rouge, LA Investigative Site 10030

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Hammond, LA Investigative Site 10106

Recruiting

Hammond, Louisiana, United States, 70403

Contacts

West Monroe, LA Investigative Site 10090

Recruiting

West Monroe, Louisiana, United States, 71291

Contacts

Baltimore, MD Investigative Site 10101

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Bowie, MD Investigative Site 10020

Recruiting

Bowie, Maryland, United States, 20715

Contacts

Boston, MA Investigative Stie 10087

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Minneapolis, MN Investigative Site 10091

Recruiting

Minneapolis, Minnesota, United States, 55407-1139

Contacts

Minneapolis, MN Investigative Site 10035

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Kansas City, MO Investigative Site 10002

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Omaha, NE Investigative Site 10018

Recruiting

Omaha, Nebraska, United States, 68105

Contacts

Camden, NJ Investigative Site 10033

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Roslyn, NY Investigative Site 10058

Recruiting

Roslyn, New York, United States, 11576

Contacts

Stony Brook, NY Investigative Site 10017

Recruiting

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

Contacts

Greenville, NC Investigative Site 10122

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Akron, OH Investigative Site 10081

Recruiting

Akron, Ohio, United States, 44304

Contacts

Centerville, OH Investigative Site 10119

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Cincinnati, OH Investigative Site 10088

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Bartlesville, OK Investigative Site 10095

Recruiting

Bartlesville, Oklahoma, United States, 74006

Contacts

Philadelphia, PA Investigative Site 10068

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Pittsburg, PA Investigative Site 1044

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Providence, RI Investigative Site 10050

Recruiting

Providence, Rhode Island, United States, 02908

Contacts

Charleston, SC Investigative Site 10056

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Germantown, TN Investigative Site 10063

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Memphis, TN Investigative Site 10059

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Nashville, TN Investigative Site 10071

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Amarillo, TX Investigative Site 10045

Recruiting

Amarillo, Texas, United States, 79106

Contacts

Austin, TX Investigative Site 10015

Recruiting

Austin, Texas, United States, 78705

Contacts

Dallas, TX Investigative Site 10042

Recruiting

Dallas, Texas, United States, 75216

Contacts

Houston, TX Investigative Site 10085

Recruiting

Houston, Texas, United States, 77030

Contacts

Plano, TX Investigative Site 10014

Recruiting

Plano, Texas, United States, 75093

Contacts

Burlington, VT Investigative Site 10053

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Norfolk, VA Investigative Site 10009

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Richmond, VA Investigative Site 10069

Recruiting

Richmond, Virginia, United States, 23225

Contacts

Richmond, VA Investigative Site 10067

Recruiting

Richmond, Virginia, United States, 23249

Contacts

Marc Bonaca, MD

+1-303-860-9900

Salem, VA Investigative Site 10048

Recruiting

Salem, Virginia, United States, 24153

Contacts

Milwaukee, WI Investigative Site 10061

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Calgary, AB Investigative Site 11009

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Edmonton, AB Investigative Site 11018

Recruiting

Edmonton, Alberta, Canada, T5H 3V9

Contacts

Edmonton, Alberta Investigative Site 11011

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Kamloops, BC Investigative Site 11021

Recruiting

Kamloops, British Columbia, Canada, V2C 2T1

Contacts

Surrey, British Columbia Investigative Site 11012

Recruiting

Surrey, British Columbia, Canada, V3V 0C6

Contacts

Vancouver, BC Investigative Site 11017

Recruiting

Vancouver, British Columbia, Canada, V6E 1M7

Contacts

Winnipeg, MB Investigative Site 11006

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Contacts

Cambridge, ON Investigative Site 11003

Recruiting

Cambridge, Ontario, Canada, N1R6V6

Contacts

Sudbury, ON Investigative Site 11016

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Contacts

London, ON Investigative Site 11010

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

North York, Ontario Investigative Site 11007

Recruiting

North York, Ontario, Canada, M6B3H7

Contacts

Toronto, Ontario Investigative Site 11008

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Toronto, ON Investigative Site 11019

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Toronto, ON Investigative Site 11001

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Sherbrooke, QC Investigative Site 11005

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Regina, SK Investigative Site 11022

Recruiting

Regina, Saskatchewan, Canada, S4P 0W5

Contacts

More Information

Sponsor

Colorado Prevention Center

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Heart failure
  • Preserved ejection fraction
  • Mildly reduced ejection fraction
  • Hospitalized

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Colorado Prevention Center on 2026-07-06.