Effect of Henagliflozin on Myocardial Fibrosis in Non-Obstructive HCM: A Randomized, Double-Blind… (NCT07294495) | Clinical Trial Compass
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Effect of Henagliflozin on Myocardial Fibrosis in Non-Obstructive HCM: A Randomized, Double-Blind, Placebo-Controlled Trial Using 68Ga/18F-FAPI PET/CMR
China150 participantsStarted 2026-01-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged 18 years or older, regardless of gender.
✓. Meets the diagnostic criteria for non-obstructive hypertrophic cardiomyopathy (HCM):
Exclusion criteria
✕. 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.
✕. Significant left ventricular outflow tract obstruction (resting or provoked LVOT pressure gradient ≥30 mmHg).
✕. Coexistence of other identifiable causes of myocardial hypertrophy, including:
✕. Overt decompensated heart failure or NYHA functional class IV.
What they're measuring
1
Change in Myocardial FAPI Target-to-Background Ratio (ΔTBR)
Timeframe: From baseline to 6 months post-intervention