Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT07294495
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07294495
Study Brief:
Protocol Section:
NCT07294495