Effect of Henagliflozin on Myocardial Fibrosis in Non-Obstructive HCM: A Randomized, Double-Blind, Placebo-Controlled Trial Using 68Ga/18F-FAPI PET/CMR

Korábbi kezelés

• Concurrent other severe systemic disease with a life expectancy of less than 1 year.

Más betegség

• 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.

Laborértékek

• 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.

Egyéb

• Significant left ventricular outflow tract obstruction (resting or provoked LVOT pressure gradient ≥30 mmHg).
• Pregnant or breastfeeding women.

• 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.