NCT07294495Not yet recruiting
Effect of Henagliflozin on Myocardial Fibrosis in Non-Obstructive HCM: A Randomized, Double-Blind, Placebo-Controlled Trial Using 68Ga/18F-FAPI PET/CMR
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effect of Henagliflozin on Myocardial Fibrosis Burden in Patients With Non-Obstructive Hypertrophic Cardiomyopathy Using 68Ga/18F-FAPI PET/CMR
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
his is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of Henagliflozin (an SGLT2 inhibitor) on myocardial fibrosis burden in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). The study will use 68 68 Ga/ 18 18 F-FAPI PET/CMR imaging to quantitatively assess changes in active fibroblast activity after 6 months of treatment. A total of 150 eligible adult patients with nHCM (FAPI-positive at baseline, NYHA class I-III) will be enrolled and randomized in a 1:1 ratio to either the Henagliflozin group (10 mg once daily) or the placebo group for a 6-month treatment period. The primary endpoint is the change in myocardial FAPI target-to-background ratio (ΔTBR) at 6 months. Secondary endpoints include changes in FAPI SUVmax, FAPI burden percentage (FAV%), cardiac structure and function parameters, 6-minute walk distance, NYHA classification, NT-proBNP levels, and quality-of-life scores. Exploratory analyses will assess clinical events over 12 months, such as heart failure hospitalization, atrial fibrillation, ventricular arrhythmias, and cardiovascular death. The study employs stratified block randomization based on baseline FAPI burden, central randomization and blinding via IWRS, independent core laboratory imaging evaluation, and an intention-to-treat analytical approach. It aims to provide early evidence for the anti-fibrotic effect of Henagliflozin in nHCM and to validate FAPI-PET/CMR as an imaging biomarker for fibrosis activity.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 8 Dec 2025
- Start date
- 7 Jan 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Shanghai East Hospital
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07294495
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 7 Jan 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent other severe systemic disease with a life expectancy of less than 1 year.
Other illness
- 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).
- Overt decompensated heart failure or NYHA functional class IV.
- Unstable, serious arrhythmias (e.g., sustained ventricular tachycardia, recent cardioversion for atrial fibrillation).
- Recent (within 3 months) cardiac surgery or interventional procedure.
- History of allergy to the study drug or any contraindication to its use.
- Any other condition deemed by the investigator to make the subject unsuitable for participation.
Lab values
- 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.
Other
- Significant left ventricular outflow tract obstruction (resting or provoked LVOT pressure gradient ≥30 mmHg).
- Pregnant or breastfeeding women.
Who the study is looking for
- Aged 18 years or older, regardless of gender.
- 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.
- Willing to undergo FAPI PET/CMR examination and complete imaging evaluations.
- 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.
- Capable of understanding and signing the informed consent form, and agrees to participate in the study, accept randomization, and comply with follow-up visits.
- New York Heart Association (NYHA) functional class I-III.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.