Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure
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.
• 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\>
‣ Systolic blood pressure ≥100 mmHg and no symptoms of hypotension within 6 hours prior to randomization\<br\>
⁃ No increase in intravenous diuretic dose or intravenous vasodilators within 6 hours prior to randomization with worsening HF symptom\<br\>
⁃ Without cardiogenic shock, no use of inotropes or vasopressors, no use of mechanical circulatory support, not requiring intubation after admission, and not expected to require inotropes, vasopressors, mechanical circulatory support or intubation during the index hospitalization\<br\>
• NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL (For patients treated with ARNI in the previous 4 weeks prior to randomization, only NT-proBNP values should be used)\<br\>
• Most recent LVEF ≥40% within the past 1 year \<br\>
• Randomization within 24 hours after admission, and drug administration within 36 hours after admission \<br\>
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\<br\>
• Signed informed consent must be obtained prior to participation in the study\<br\>