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

ConditionAcute Heart Failure

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorJuntendo University

About this trial

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.

Eligibility criteria

Qualifiers

Patients ≥18 years of age, male or female

Current hospitalization with AHF requiring intravenous loop diuretics or vasodilators during the index admission

Patients have to have at least one of new or worsening symptoms due to HF and one of new or worsening physical examination findings due to HF (i) symptom dyspnoea, decreased exercise tolerance, or fatigue (ii) physical examination peripheral edema, increasing abdominal distention or ascites, pulmonary rales/crackles/crepitations, increased jugular venous pressure and/or hepatojugular reflux, S3 gallop, clinically significant or rapid weight gain

Patients who are not hemodynamically unstable as defined by meeting the following criteria

Disqualifiers

Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m2 by CKD-EPI Creatinine Equation (2021) at screening

Serum/plasma potassium >5.0 mmol/L at screening

Patients who cannot receive oral treatment

Use of eplerenone, spironolactone, esaxerenone or potassium-sparing diuretic within 30 days before randomization

Trial design

Treatments tested in this trial

Finerenone Oral Tablet
Finerenone Placebo

Treatment groups

550 Participants

are divided into 2 treatment groups

Locations21

Select a site below to view it on the map.

Sponsors and collaborators

Juntendo University

Lead sponsor

Source ClinicalTrials.gov