Can a pill reverse heart scarring? new study aims to find out
NCT ID NCT07583173
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug finerenone can reduce scarring in the heart muscle and improve heart structure and function in people with heart failure. About 104 adults with mild to moderate heart failure will receive either finerenone or a placebo for 6 months. The main goal is to see if finerenone reduces a measure of heart scarring called extracellular volume, as seen on MRI scans.
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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 104 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 to 80 years
- 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.
Inclusion Criteria: 1. Aged 18 to 80 years (inclusive), any gender. 2. Symptomatic heart failure (NYHA class II-IV). 3. Emergency department visit or hospitalization for HF within the past 3 months, or escalation of intravenous or oral diuretic therapy for worsening HF within the past 3 months. 4. LVEF ≥40% measured by echocardiography or CMR within the past 30 days prior to screening. 5. NT-proBNP ≥300 pg/mL for patients in sinus rhythm; NT-proBNP ≥900 pg/mL for patients with atrial fibrillation. 6. Presence of myocardial fibrosis, defined as ECV ≥27% measured by CMR at baseline. 7. Capable of providing voluntary written informed consent. Exclusion Criteria: * 1\. eGFR \<25 mL/min/1.73 m² at screening or enrollment. 2. Serum potassium concentration ≥5.0 mmol/L at screening or enrollment. 3. Prior confirmed diagnosis of HFrEF. 4. Acute inflammatory heart disease (e.g., acute myocarditis). 5. Acute myocardial infarction or other event likely to have reduced LVEF within 30 days prior to randomization. 6\. Coronary artery bypass grafting within 30 days prior to randomization. 7. Percutaneous coronary intervention within 30 days prior to randomization. 8. History of stroke or transient ischemic attack (TIA) within 90 days prior to randomization. 9\. Conditions where the investigator considers the primary cause of dyspnea (and thus heart failure symptoms) to be severe pulmonary disease, anemia, or obesity. Specific exclusions include: severe pulmonary disease requiring home oxygen therapy or long-term oral steroids; history of primary pulmonary hypertension; hemoglobin \<100 g/L; severe valvular heart disease; BMI ≥50 kg/m². 10\. Systolic blood pressure (SBP) \>160 mmHg despite combination therapy with 3 antihypertensive drugs, OR SBP \>180 mmHg on any treatment measured on (two consecutive occasions at least 2 minutes apart). 11\. Severe malignant ventricular arrhythmia or atrial fibrillation with resting ventricular rate \>100 bpm. 12\. Symptomatic hypotension with mean SBP \<90 mmHg. 13. Any HF condition requiring surgical intervention (e.g., severe aortic stenosis or mitral regurgitation). 14\. History of peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, primary right ventricular cardiomyopathy, constrictive pericarditis, hereditary hypertrophic cardiomyopathy, or infiltrative cardiomyopathy (including amyloidosis). 15\. Contraindications to CMR (e.g., magnetic metal implants, claustrophobia, contrast allergy). 16\. History of hyperkalemia or acute renal failure during prior MRA therapy. 17. Known allergy or severe adverse reaction to finerenone. 18. History of severe hepatic impairment (Child-Pugh C). 19. Requirement for any intravenous inotropic drugs or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) within 24 hours prior to randomization. 20\. Current or prior use (within 4 weeks before screening) of any MRA (e.g., spironolactone, eplerenone, canrenone, esaxerenone). 21\. Use of renin inhibitors or potassium-sparing diuretics prior to randomization that cannot be discontinued. 22\. Severe comorbidities (e.g., malignancy, lymphoma, cirrhosis, HIV-positive) with life expectancy \<2 years. 23\. Pregnancy, lactation, or planning pregnancy. Women of childbearing potential must have a negative serum pregnancy test pre-treatment, agree to serum/urine pregnancy tests at study visits (Months 3 and 6), and commit to using highly effective contraception during the study and for 3 months after. Male participants with female partners of childbearing potential must also agree to use highly effective contraception during the study and for 3 months after. 24\. Participation in another clinical trial within 3 months prior to this study. 25\. Any condition, in the investigator's judgment, that would preclude safe study participation or protocol compliance.
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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
1 site. 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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Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Beijing, 100037, China
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Other studies related to the condition(s) this trial covers.
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- Can better training get doctors to talk about what matters most to dying veterans?
- Can AI read heart ultrasounds as well as trained sonographers?
- Can modern heart failure drugs reverse damage in three months?