Skip to main content
Clinical Trials/NCT06775665
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.

Registry
clinicaltrials.gov
Start Date
June 1, 2026
End Date
June 1, 2032
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

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)

Loading locations...

Similar Trials