Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure

Sponsor
Juntendo University
Study ID
NCT07397650
Phase
PHASE4
Status
Recruiting
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Conditions

  • Acute Heart Failure

Eligibility Criteria

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

Interventions

  • Finerenone Oral Tablet — DRUG
    For participants with an eGFR ≤60 mL/min/1.73 m\^2: Starting dose is 10 mg OD and maximum dose 20 mg OD. For participants with an eGFR \>60 mL/min/1.73 m\^2: Starting dose is 20 mg OD and maximum dose 40 mg OD.
  • Finerenone Placebo — DRUG
    Placebo tablets matching finerenone are administered orally

Study Details

FACILITATE-HF is a multicenter, randomized, double-blind, placebo-controlled trial designed to determine whether initiation of finerenone during the early phase of hospitalization has beneficial effects in patients with AHF who have left ventricular ejection fraction 40% or more.

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone
    Patients will be randomized 1:1 to either finerenone or placebo.
  • Placebo Comparator: Placebo
    Placebo tablets matching finerenone are administered orally

Primary Outcome Measure

A hierarchical composite endpoint of death and worsening heart failure [ Time Frame: Up to 12 weeks ]

Central Contacts

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