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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

This trial does not accept healthy volunteers

Qualifiers

Patients ≥18 years of age, male or female<br>

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

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 <br> (i) symptom<br> dyspnoea, decreased exercise tolerance, or fatigue<br> (ii) physical examination<br> 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<br>

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

Disqualifiers

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

Serum/plasma potassium >5.0 mmol/L at screening<br>

Patients who cannot receive oral treatment<br>

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: FinerenoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

A hierarchical composite endpoint of death and worsening heart failure

A hierarchical composite endpoint consisting of death, worsening HF during hospitalization, HF rehospitalization, worsening HF after discharge requiring IV diuretic or sustained intensification of oral therapy, and change in N-terminal pro-B-type natriuretic peptide levels at 12 weeks as assessed using a win ratio

Time frame
Up to 12 weeks

Secondary outcomes

1

All-cause death

Time frame
Up to 12 weeks
2

Cardiovascular death

Time frame
Up to 12 weeks
3

Worsening HF during hospitalization

Time frame
During hospitalization
4

HF rehospitalization

Time frame
Up to 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Juntendo University

Lead sponsor

Source ClinicalTrials.gov
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