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
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the early use of finerenone in patients hospitalized with acute heart failure who have a left ventricular ejection fraction of 40% or more. This phase 4, randomized, double-blind, placebo-controlled trial aims to determine if starting finerenone soon after hospital admission benefits these patients. The study is led by Juntendo University and focuses on improving outcomes related to death and worsening heart failure. Participants are randomly assigned to receive either finerenone or a placebo that looks identical. Finerenone doses depend on kidney function, with lower doses for patients with reduced estimated glomerular filtration rate (eGFR) and higher doses for those with better kidney function. The treatment begins within 36 hours after hospital admission and continues for up to 12 weeks. The trial includes close monitoring during hospitalization and follow-up after discharge. During the study, participants undergo assessments including measurement of heart failure symptoms, kidney function, urine output, and heart-related biomarkers like NT-proBNP. Researchers will evaluate outcomes such as death, worsening heart failure, rehospitalization, and symptom changes for up to 12 weeks. Safety and adherence are carefully monitored throughout the trial. Total participation time for each person is up to 12 weeks from hospitalization.
CONDITIONS
Brief 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
- Presence of new or worsening heart failure symptoms such as shortness of breath, decreased exercise tolerance, or fatigue
- Presence of new or worsening physical signs like peripheral edema, increased abdominal swelling, lung crackles, or rapid weight gain
- Hemodynamically stable with systolic blood pressure 100 mmHg or higher and no symptoms of low blood pressure within 6 hours before randomization
- No recent increase in intravenous diuretics or vasodilators within 6 hours before randomization
- No cardiogenic shock or need for inotropes, vasopressors, mechanical support, or intubation expected during hospitalization
- NT-proBNP 1500 pg/mL or higher or BNP 375 pg/mL or higher
- Left ventricular ejection fraction of 40% or more within the past year
- Randomization and drug administration within 24 and 36 hours of admission respectively
- Able to provide signed informed consent and comply with study requirements
You will not qualify if you...
- Estimated glomerular filtration rate below 25 mL/min/1.73m2 at screening
- Serum or plasma potassium level above 5.0 mmol/L at screening
- Unable to receive oral medication
- Use of certain potassium-sparing diuretics within 30 days before randomization
- Known allergy to the study drug or its ingredients
- Recent use or expected use of strong CYP3A4 inhibitors or inducers during the study
- Need for simultaneous treatment with more than one ACE inhibitor, ARB, or angiotensin-receptor neprilysin inhibitor
- Acute heart failure caused mainly by other diseases such as COPD or anemia
- Current dialysis or expected to start dialysis during the study
- Pregnant or breastfeeding women
- Recent major cardiovascular events or surgeries within specified timeframes
- Heart transplant recipients or candidates expecting transplant during the study
- Certain heart conditions requiring surgery or device implantation during the study
- Secondary cardiomyopathies or specific heart diseases
- Acute cardiac structural problems
- Active myocarditis or peripartum cardiomyopathy diagnosed recently
- Symptomatic bradycardia requiring temporary pacemaker at admission
- Uncontrolled thyroid disease or Addison's disease
- Severe liver failure classified as Child-Pugh C
- Excessive alcohol use
- Other conditions limiting life expectancy to less than 12 months or affecting study participation
- Dementia or significant cognitive impairment
- Participation in another interventional clinical trial within 30 days
- Any condition making the participant unsuitable as judged by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 weeks
Participants receive either finerenone or placebo tablets orally while hospitalized for heart failure.
Randomization and drug administration occur within 24 to 36 hours of hospital admission.
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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