A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists

Part of paid clinical trials in Fairhope, Alabama.

Sponsor
Colorado Prevention Center
Study ID
NCT06033950
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Finerenone — DRUG
    Oral finerenone.
  • Placebo — DRUG
    Matching oral placebo.

Study Details

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).

Key Dates

Start date
Aug 20, 2024
Status verified
Mar 2025
Primary completion
Mar 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
2,600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone
  • Placebo Comparator: Placebo

Primary Outcome Measure

Time to first occurrence of cardiovascular (CV) death or HF event. [ Time Frame: Ongoing, up to ~30 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
FIN-10004 Fairhope, AL Investigational SiteFairhopeAlabama36532-
FIN-10075 San Diego, CA Investigational SiteSan DiegoCalifornia92243
Marc Bonaca, MD
FIN-10002 Kansas City, MO Investigational SiteKansas CityMissouri64111
Marc Bonaca
FIN-10015 Austin, TX Investigational SiteAustinTexas78705-

Find similar trials in Fairhope, AL

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
FIN-10004 Fairhope, AL Investigational Site· Fairhope, ALFIN-10075 San Diego, CA Investigational Site· San Diego, CAFIN-10002 Kansas City, MO Investigational Site· Kansas City, MOFIN-10015 Austin, TX Investigational Site· Austin, TX

Related Studies