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New pill could cut heart failure deaths when given early in hospital
NCT ID NCT07397650
First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This study tests whether starting the drug finerenone early during a hospital stay for acute heart failure can improve outcomes. About 550 adults with heart failure and preserved ejection fraction will receive either finerenone or a placebo. Researchers will track deaths, worsening heart failure, and symptom changes over 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Finerenone oral tablet
- What this could lead to
- If successful, this could show that starting finerenone early in the hospital reduces death and worsening heart failure events after discharge.
- What could go wrong
- This is a phase 4 trial, but heart failure is complex and results may not apply to all patients. The benefit may be modest or not statistically significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 550 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Patients eligible for inclusion in this study meet all of the following criteria: \<br\>Inclusion Criteria: 1. Patients ≥18 years of age, male or female\<br\> 2. Current hospitalization with AHF requiring intravenous loop diuretics or vasodilators during the index admission\<br\> 3. 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\> 4. Patients who are not hemodynamically unstable as defined by meeting the following criteria\<br\> 1. Systolic blood pressure ≥100 mmHg and no symptoms of hypotension within 6 hours prior to randomization\<br\> 2. No increase in intravenous diuretic dose or intravenous vasodilators within 6 hours prior to randomization with worsening HF symptom\<br\> 3. 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\> 5. 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\> 6. Most recent LVEF ≥40% within the past 1 year \<br\> 7. Randomization within 24 hours after admission, and drug administration within 36 hours after admission \<br\> 8. 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\> 9. Signed informed consent must be obtained prior to participation in the study\<br\> Exclusion Criteria: 1. Estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73m2 by CKD-EPI Creatinine Equation (2021) at screening\<br\> 2. Serum/plasma potassium \>5.0 mmol/L at screening\<br\> 3. Patients who cannot receive oral treatment\<br\> 4. Use of eplerenone, spironolactone, esaxerenone or potassium-sparing diuretic within 30 days before randomization \<br\> 5. Known hypersensitivity to the study intervention (active substance or excipients)\<br\> 6. 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\> 7. Participants who require treatment with more than one ACEI, ARB or angiotensin-receptor neprilysin inhibitor (ARNI) simultaneously\<br\> 8. Acute heart failure in which other diseases are the main cause of symptoms and signs (chronic obstructive pulmonary disease, anemia, etc.)\<br\> 9. Patients who are on dialysis including peritoneal dialysis or in whom the initiation of dialysis during the study period\<br\> 10. Pregnant or lactating female\<br\> 11. Acute coronary syndrome, pulmonary thromboembolism, stroke, or transient ischemic attack within 90 days before randomization.\<br\> 12. Have undergone the following therapeutic intervention within 30 days before randomization: cardiovascular surgery (e.g., coronary artery bypass grafting, surgery for valvular heart disease, transcatheter aortic valve implantation, percutaneous coronary intervention, percutaneous edge-to-edge mitral valve repair, and other types of surgery at the investigator's discretion) and implantation of an implantable defibrillator, or a cardiac resynchronization therapy defibrillator.\<br\> 13. Heart transplant recipients or patients listed for heart transplantation who are expected to undergo transplantation during the study, patients implanted with an implantable ventricular-assist device, patients expected to require an implantable ventricular-assist device during the study, and patients expected to switch to palliative care during the study.\<br\> 14. Coronary or valvular heart disease likely to require surgical or percutaneous intervention within the study period (there is no reason to exclude secondary mitral or tricuspid regurgitation due to reduced cardiac function, except for the absence of a plan to perform cardiac surgery or therapeutic catheterization)\<br\> 15. Secondary cardiomyopathy such as amyloidosis, cardiac sarcoidosis, hemochromatosis, Fabry's disease, chemotherapy induced cardiomyopathy, and muscular dystrophy. Heart failure due to takotsubo cardiomyopathy, obstructive hypertrophic cardiomyopathy, complex congenital heart disease (as determined by the investigator), pericardial constriction, right heart failure in absence of left-sided structural disease\<br\> 16. Acute cardiac structural abnormalities (e.g., acute mitral regurgitation due to ruptured chordae tendineae and infective endocarditis)\<br\> 17. Peripartum cardiomyopathy diagnosed within 6 months before randomization.\<br\> 18. Active myocarditis at randomization.\<br\> 19. Patients with symptomatic bradycardia or complete atrioventricular block who are being treated with temporary pacemaker implantation at the time of admission, or who are expected to require temporary or permanent pacemaker implantation in the future. Patients who have already been treated with permanent pacemaker implantation do not meet the exclusion criteria\<br\> 20. Presence of uncontrolled thyroid disease\<br\> 21. Addison's disease\<br\> 22. Hepatic insufficiency classified as Child-Pugh C \<br\> 23. Patients with excessive alcohol intake (15+ drinks/week for men, 8+ drinks/week for women)\<br\> 24. Any other condition or therapy, which would make the participant unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months)\<br\> 25. Patients with dementia. If a sub-investigator determines that confirmation of cognitive impairment is necessary, it must be verified that the Mini-Cog score is not less than 4.\<br\> 26. Participation in another interventional clinical study (e.g. phase 1 to 3 clinical studies) or treatment with another investigational medicinal product within 30 days prior to randomization.Other conditions likely to interfere with the patient's safety or compliance with the protocol\<br\> 27. Patients deemed unsuitable by the principal investigator or sub investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
21 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chita Peninsula General Medical Center
RECRUITINGHanda, Aichi-ken, Japan
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Chutoen General Medical Center
RECRUITINGKakegawa, Shizuoka, Japan
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Ehime University Hospital
RECRUITINGTōon, Ehime, Japan
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Gunma Prefectural Cardiovascular Center
NOT_YET_RECRUITINGMaebashi, Gunma, Japan
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Gunma University Hospital
RECRUITINGMaebashi, Gunma, Japan
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Hokkaido Cardiovascular Hospital
RECRUITINGSapporo, Hokkaido, Japan
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Iizuka Hospital
RECRUITINGIizuka, Fukuoka, Japan
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Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
NOT_YET_RECRUITINGNagoya, Aichi-ken, Japan
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Japanese Red Cross Fukuoka Hospital
NOT_YET_RECRUITINGFukuoka, Fukuoka, Japan
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Juntendo University Hospital
RECRUITINGTokyo, Japan
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Juntendo University Shizuoka Hospital
NOT_YET_RECRUITINGIzunokuni, Shizuoka, Japan
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Kindai University Hospital
RECRUITINGSakai, Osaka, Japan
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Kitasato University Hospital
NOT_YET_RECRUITINGSagamihara, Kanagawa, Japan
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NHO Takasaki General Medical Center
RECRUITINGTakasaki, Gunma, Japan
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Nagoya University Hospital
RECRUITINGNagoya, Aichi-ken, Japan
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National Center for Geriatrics and Gerontology
NOT_YET_RECRUITINGŌbu, Aichi-ken, Japan
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National Cerebral and Cardiovascular Center
NOT_YET_RECRUITINGSuita, Osaka, Japan
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Osaka General Medical Center
RECRUITINGOsaka, Japan
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Saitama Medical Center
NOT_YET_RECRUITINGKawagoe, Saitama, Japan
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The University of Osaka Hospital
RECRUITINGSuita, Osaka, Japan
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Toyota Kosei Hospital
RECRUITINGToyota, Aichi-ken, Japan
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