NCT06775665
Not Yet Recruiting
N/A
Clinical Characteristics and Real-World Outcomes of Chinese Patients With Hypertrophic Cardiomyopathy: A Prospective Cohort Study
Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country3,000 target enrollmentJune 1, 2026
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- Composite Cardiovascular Endpoints
- Status
- Not Yet Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
This study is a prospective cohort study aimed at exploring the baseline characteristics and treatment patterns of the Chinese population with hypertrophic cardiomyopathy (HCM) in real-world settings. The objective is to assess the real-world treatment approaches and longitudinal outcomes in this population.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing and able to provide written informed consent (ICF) and any required privacy authorization before the start of the study.
- •Aged ≥18 years at the time of signing the written informed consent.
- •Diagnosed with hypertrophic cardiomyopathy (HCM) according to the 2023 Guideline for Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy, meeting the following criteria:
- •Left ventricular wall thickness ≥15 mm in any segment at end-diastole, as assessed by echocardiography or cardiac magnetic resonance imaging (MRI).
- •Left ventricular wall thickness ≥13 mm in individuals with a positive pathogenic gene test or those identified as members of a genetically affected family.
- •Exclusion of other cardiovascular diseases or systemic/metabolic diseases causing ventricular wall thickening.
Exclusion Criteria
- •Uncontrolled primary hypertension.
- •Moderate or severe aortic valve stenosis and/or primary mitral valve disease with severe mitral regurgitation.
- •Confirmed infiltrative or storage diseases with a phenotype resembling hypertrophic cardiomyopathy (e.g., Fabry disease, amyloidosis).
- •Expected life expectancy \<1 years.
- •Severe infections, liver failure, renal failure, or other life-threatening conditions.
Outcomes
Primary Outcomes
Composite Cardiovascular Endpoints
Time Frame: 5 years
Number of Participants with a composite cardiovascular endpoint consisting of ischemic stroke, heart failure hospitalization, and cardiovascular death
Secondary Outcomes
- All-cause mortality(5 years)
- Cardiovascular death(5 years)
- New-onset arrhythmia(5 years)
- Sudden cardiac death (SCD)(5 years)
- Non-fatal acute myocardial infarction(5 years)
- Ischemic stroke(5 years)
- Heart failure hospitalization(5 years)
- New York Heart Association (NYHA) Classification(5 years)
- Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)(5 years)
- BNP/NT-proBNP(5 years)
- Troponin T/I(5 years)
Study Sites (1)
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