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Can a pill reverse heart scarring? new study aims to find out

NCT ID NCT07583173

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • 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.