Could a common diabetes drug heal scarred hearts?
NCT ID NCT07294495
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether henagliflozin, a drug currently used for diabetes, can reduce scarring in the heart muscle of people with a type of hypertrophic cardiomyopathy (non-obstructive HCM). The trial will enroll 150 adults and use special PET scans to measure changes in scar tissue over 6 months. If successful, it may offer a new treatment option for this heart condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Henagliflozin (a diabetes drug that may also reduce heart scarring)
- What this could lead to
- If it works, this could point toward a new way to reduce heart scarring and improve outcomes in hypertrophic cardiomyopathy.
- What could go wrong
- This is an early-phase trial with only 150 people, so results may not apply broadly. The drug is being tested for a new purpose and may not show benefit.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 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.
Inclusion Criteria: 1. Aged 18 years or older, regardless of gender. 2. Meets the diagnostic criteria for non-obstructive hypertrophic cardiomyopathy (HCM): * Confirmed diagnosis of HCM by cardiac magnetic resonance (CMR) or echocardiography (left ventricular wall thickness ≥15 mm, or ≥13 mm in the presence of a family history of HCM). * Exclusion of patients in whom left ventricular hypertrophy is primarily attributable to hypertensive heart disease, as assessed by a cardiology specialist based on clinical and imaging evidence. * Exclusion of other identifiable causes of secondary myocardial hypertrophy (e.g., valvular heart disease, storage cardiomyopathies). * Left ventricular outflow tract (LVOT) gradient \<30 mmHg at rest or under provocation, as assessed by echocardiography or CMR. 3. Willing to undergo FAPI PET/CMR examination and complete imaging evaluations. 4. Baseline FAPI PET/CMR scan shows positive FAPI uptake: myocardial FAPI target-to-background ratio (TBR) ≥1.3, using the ascending aorta blood pool as the background reference. 5. Capable of understanding and signing the informed consent form, and agrees to participate in the study, accept randomization, and comply with follow-up visits. 6. New York Heart Association (NYHA) functional class I-III. Exclusion Criteria: 1. Significant left ventricular outflow tract obstruction (resting or provoked LVOT pressure gradient ≥30 mmHg). 2. Coexistence of other identifiable causes of myocardial hypertrophy, including: * Predominant or persistent hypertensive heart disease; * Severe aortic stenosis or other significant valvular heart disease; * Infiltrative or storage cardiomyopathies (e.g., Fabry disease, amyloidosis); * Ischemic heart disease (e.g., severe coronary artery disease). 3. Overt decompensated heart failure or NYHA functional class IV. 4. Unstable, serious arrhythmias (e.g., sustained ventricular tachycardia, recent cardioversion for atrial fibrillation). 5. Recent (within 3 months) cardiac surgery or interventional procedure. 6. ALT or AST \>3 times the upper limit of normal (ULN), OR total bilirubin (Tbil) \>2 times ULN, OR ketonuria/ketonemia, OR eGFR \<30 mL/min/1.73m², OR creatine kinase (CK) \>3 times ULN. 7. Concurrent other severe systemic disease with a life expectancy of less than 1 year. 8. Pregnant or breastfeeding women. 9. History of allergy to the study drug or any contraindication to its use. 10. Any other condition deemed by the investigator to make the subject unsuitable for participation.
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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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Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.