Recruiting
Phase 3

Finerenone

Sponsor:

Colorado Prevention Center

Code:

NCT06033950

Conditions

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 with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).

Conditions

Heart Failure

Study ID

NCT06033950

Start date

Aug 20, 2024

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • Symptomatic HFrEF per protocol defined criteria
  • Not on sMRA due to history of intolerance, contraindication, or ineligibility for treatment
  • Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)

Exclusion Criteria:

  • Treatment with non-steroidal MRA (nsMRA)
  • Documented prior history of severe hyperkalemia in the setting of MRA use
  • eGFR < 25 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 or planned
  • Prior or planned heart transplant
  • Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure
  • Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
  • Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
  • Probable alternative cause of participant's HF
  • Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers
  • Known hypersensitivity to the IP (active substance or excipients)
  • Any other condition or therapy which would make the participant unsuitable for the study
  • Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization

Study Design

Enrollment

2600 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

  • Time to first occurrence of cardiovascular (CV) death or HF event. [ 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

Marc Bonaca

(303) 860-9900info@cpcmed.org

Locations

FIN-10004 Fairhope, AL Investigational Site

Recruiting

Fairhope, Alabama, United States, 36532

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

Phoenix, AZ Investigative Site FIN-10115

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10401, Yuma, AZ

Recruiting

Yuma, Arizona, United States, 85365

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

Chula Vista, CA Investigative Site FIN-10419

Recruiting

Chula Vista, California, United States, 91910

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

Chula Vista, CA Investigative Site FIN-10111

Recruiting

Chula Vista, California, United States, 91911

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10407, Northridge, CA

Recruiting

Northridge, California, United States, 91324

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10412, Orange, CA

Recruiting

Orange, California, United States, 92866

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10070, Pamona, CA

Recruiting

Pomona, California, United States, 91767

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10024, Sacramento, CA

Recruiting

Sacramento, California, United States, 95816

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10406, San Diego, CA

Recruiting

San Diego, California, United States, 91127

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

San Diego, CA Investigative Site FIN-10420

Recruiting

San Diego, California, United States, 92111

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10075 San Diego, CA Investigational Site

Recruiting

San Diego, California, United States, 92243

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

San Francisco, CA Investigative Site FIN-10023

Recruiting

San Francisco, California, United States, 94118

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10423, Sherman Oaks, CA

Recruiting

Sherman Oaks, California, United States, 91403

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FON-10409, Tarzana, CA

Recruiting

Tarzana, California, United States, 91356

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10109, Van Nuys, CA

Recruiting

Van Nuys, California, United States, 91405

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10408, West Covina, CA

Recruiting

West Covina, California, United States, 91790

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10013, West Hills, CA

Recruiting

West Hills, California, United States, 91307

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10110, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80012

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10001, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

Bradenton, FL Investigative Site FIN-10125

Recruiting

Bradenton, Florida, United States, 34209

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10104, Hialeah, FL

Recruiting

Hialeah, Florida, United States, 33012

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10028, Jacksonville, FL

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10105, Miami, FL

Recruiting

Miami, Florida, United States, 33135

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10113, Miramar, FL

Recruiting

Miramar, Florida, United States, 33027

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10019, Peoria, IL

Recruiting

Peoria, Illinois, United States, 61603

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10064, Merrillville, IN

Recruiting

Merrillville, Indiana, United States, 46410

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

Cynthiana, KY Investigative Site FIN-10124

Recruiting

Cynthiana, Kentucky, United States, 41031

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10080, Lexington, KY

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

Lexington, KY Investigative Site FIN-10118

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10086, Louisville, KY

Recruiting

Louisville, Kentucky, United States, 40205

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

Louisville, KY Investigative Site FIN-10417

Recruiting

Louisville, Kentucky, United States, 40205

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10079, Paducah, KY

Recruiting

Paducah, Kentucky, United States, 42003

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10030, Baton Rouge, LA

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10106, Hammond, LA

Recruiting

Hammond, Louisiana, United States, 70403

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10090, West Monroe, LA

Recruiting

West Monroe, Louisiana, United States, 71291

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

Minneapolis, MN Investigative Site FIN-10035

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10002 Kansas City, MO Investigational Site

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Bonaca

+1-303-860-9900info@cpcmed.org

FIN-10318, Charlotte, NC

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

Greenville, NC Investigative Site FIN-10122

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10081, Akron, OH

Recruiting

Akron, Ohio, United States, 44304

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10119, Centerville, OH

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN- 10112, Cincinnati, OH

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

Orangeburg, SC Investigative Site FIN-10433

Recruiting

Orangeburg, South Carolina, United States, 29118

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10015 Austin, TX Investigational Site

Recruiting

Austin, Texas, United States, 78705

Contacts

Bonaca

+1-303-860-9900info@cpcmed.org

FIN-10404, Denison, TX

Recruiting

Denison, Texas, United States, 75020

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10085, Houston, TX

Recruiting

Houston, Texas, United States, 77030

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

Tyler, TX Investigative Site FIN-10422

Recruiting

Tyler, Texas, United States, 75702

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10405, Layton, UT

Recruiting

Layton, Utah, United States, 84041

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10053, Burlington, VT

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10402, Norfolk, VA

Recruiting

Norfolk, Virginia, United States, 23510

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-10093, Richmond, VA

Recruiting

Richmond, Virginia, United States, 23298-5051

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

Salem, VA Investigative Site FIN-10048

Recruiting

Salem, Virginia, United States, 24153

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

Milwaukee, WI Investigative Site FIN-10428

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

Calgary, AB Investigative Site FIN-11009

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Marc Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11028, Edmonton, AB

Recruiting

Edmonton, Alberta, Canada, T5H 4B9

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11011, Edmonton, AB

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11020, North Vancouver, BC

Recruiting

North Vancouver, British Columbia, Canada, V7M 2H4

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11012 Surrey, BC Investigational Site

Recruiting

Surrey, British Columbia, Canada, V3V OC6

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11025, Victoria, BC

Recruiting

Victoria, British Columbia, Canada, V8R 1B2

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11006, Winnipeg, MB

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11016, Sudbury, ON

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11024, Kingston, ON

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11010, London, ON

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11007, North York, ON

Recruiting

North York, Ontario, Canada, M6B 3H7

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11008, Toronto, ON

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11019, Toronto, ON

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

FIN-11005, Sherbrooke, QC

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

More Information

Sponsor

Colorado Prevention Center

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Reduced ejection fraction
  • Symptomatic heart failure

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 2026-07-10.