Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure (NCT07397650) | Clinical Trial Compass
RecruitingPhase 4
Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure
Japan550 participantsStarted 2026-05-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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\>
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A hierarchical composite endpoint of death and worsening heart failure
. 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\>
Exclusion criteria
. 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\>
. Known hypersensitivity to the study intervention (active substance or excipients)\<br\>
. Systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers within 7 days before randomization or is expected to be used during the study period (e.g. itraconazole, ritonavir, indinavir, cobicistat, clarithromycin).\<br\>
. Participants who require treatment with more than one ACEI, ARB or angiotensin-receptor neprilysin inhibitor (ARNI) simultaneously\<br\>
. Acute heart failure in which other diseases are the main cause of symptoms and signs (chronic obstructive pulmonary disease, anemia, etc.)\<br\>