Actively Recruiting
Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure
Led by Juntendo University · Updated on 2026-02-11
550
Participants Needed
21
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older, male or female
- Currently hospitalized with acute heart failure requiring intravenous loop diuretics or vasodilators
- Have at least one new or worsening symptom due to heart failure such as dyspnea, decreased exercise tolerance, or fatigue
- Have at least one new or worsening physical exam finding such as peripheral edema, abdominal distention, pulmonary rales, increased jugular venous pressure, S3 gallop, or rapid weight gain
- Are hemodynamically stable with systolic blood pressure 100 mmHg or higher and no symptoms of low blood pressure within 6 hours prior to randomization
- No increase in intravenous diuretics or vasodilators within 6 hours prior to randomization with worsening symptoms
- No cardiogenic shock, no use of inotropes or vasopressors, no mechanical circulatory support, no intubation after admission and not expected to require these during hospitalization
- NT-proBNP 1500 pg/mL or higher or BNP 375 pg/mL or higher
- Left ventricular ejection fraction 40% or higher within the past year
- Randomization within 24 hours after admission and drug administration within 36 hours
- Capable of giving signed informed consent and agreeing to study requirements
- Signed informed consent obtained before participation
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) less than 25 mL/min/1.73m2 at screening
- Serum or plasma potassium greater than 5.0 mmol/L at screening
- Unable to receive oral treatment
- Use of eplerenone, spironolactone, esaxerenone, or potassium-sparing diuretic within 30 days before randomization
- Known allergy to the study drug or its ingredients
- Use of strong CYP3A4 inhibitors or inducers within 7 days before randomization or expected use during study
- Need for treatment with more than one ACE inhibitor, ARB, or ARNI simultaneously
- Acute heart failure primarily caused by other diseases like COPD or anemia
- On dialysis or expected to start dialysis during the study
- Pregnant or breastfeeding women
- Recent acute coronary syndrome, pulmonary embolism, stroke, or transient ischemic attack within 90 days
- Recent cardiovascular surgery or implantation of cardiac devices within 30 days
- Heart transplant recipients or candidates expected to undergo transplantation during the study
- Coronary or valvular heart disease likely requiring surgery or intervention during the study
- Secondary cardiomyopathies or specific heart conditions like takotsubo cardiomyopathy
- Acute cardiac structural abnormalities
- Peripartum cardiomyopathy diagnosed within 6 months
- Active myocarditis at randomization
- Symptomatic bradycardia or complete heart block treated with temporary pacemaker
- Uncontrolled thyroid disease
- Addison's disease
- Severe liver failure classified as Child-Pugh C
- Excessive alcohol intake (15+ drinks/week for men, 8+ drinks/week for women)
- Other serious conditions or therapies limiting life expectancy to less than 12 months
- Dementia or cognitive impairment with Mini-Cog score less than 4
- Participation in another interventional clinical study or investigational drug within 30 days
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Chita Peninsula General Medical Center
Handa, Aichi-ken, Japan
Actively Recruiting
2
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan
Not Yet Recruiting
3
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Actively Recruiting
4
National Center for Geriatrics and Gerontology
Ōbu, Aichi-ken, Japan
Not Yet Recruiting
5
Toyota Kosei Hospital
Toyota, Aichi-ken, Japan
Actively Recruiting
6
Ehime University Hospital
Tōon, Ehime, Japan
Actively Recruiting
7
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, Japan
Not Yet Recruiting
8
Iizuka Hospital
Iizuka, Fukuoka, Japan
Actively Recruiting
9
Gunma Prefectural Cardiovascular Center
Maebashi, Gunma, Japan
Not Yet Recruiting
10
Gunma University Hospital
Maebashi, Gunma, Japan
Actively Recruiting
11
NHO Takasaki General Medical Center
Takasaki, Gunma, Japan
Actively Recruiting
12
Hokkaido Cardiovascular Hospital
Sapporo, Hokkaido, Japan
Actively Recruiting
13
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Not Yet Recruiting
14
Kindai University Hospital
Sakai, Osaka, Japan
Actively Recruiting
15
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
Not Yet Recruiting
16
The University of Osaka Hospital
Suita, Osaka, Japan
Actively Recruiting
17
Saitama Medical Center
Kawagoe, Saitama, Japan
Not Yet Recruiting
18
Juntendo University Shizuoka Hospital
Izunokuni, Shizuoka, Japan
Not Yet Recruiting
19
Chutoen General Medical Center
Kakegawa, Shizuoka, Japan
Actively Recruiting
20
Osaka General Medical Center
Osaka, Japan
Actively Recruiting
21
Juntendo University Hospital
Tokyo, Japan
Actively Recruiting
Research Team
Y
Yuya Matsue, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here