A Real-World Study on Hypertrophic Cardiomyopathy in the Chinese Population

Not yet recruiting

• Conditions: Hypertrophic Cardiomyopathy (HCM)

• Registration Number: NCT06775665
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Study Start: 2026-06-01
• Primary Completion: 2031-01-01
• Study Completion: 2032-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Willing and able to provide written informed consent (ICF) and any required privacy authorization before the start of the study.

2. Aged ≥18 years at the time of signing the written informed consent.

3. Diagnosed with hypertrophic cardiomyopathy (HCM) according to the 2023 Guideline for Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy, meeting the following criteria:

   1. Left ventricular wall thickness ≥15 mm in any segment at end-diastole, as assessed by echocardiography or cardiac magnetic resonance imaging (MRI).
   2. Left ventricular wall thickness ≥13 mm in individuals with a positive pathogenic gene test or those identified as members of a genetically affected family.
   3. Exclusion of other cardiovascular diseases or systemic/metabolic diseases causing ventricular wall thickening.

Exclusion Criteria

1. Uncontrolled primary hypertension.
2. Moderate or severe aortic valve stenosis and/or primary mitral valve disease with severe mitral regurgitation.
3. Confirmed infiltrative or storage diseases with a phenotype resembling hypertrophic cardiomyopathy (e.g., Fabry disease, amyloidosis).
4. Expected life expectancy <1 years.
5. Severe infections, liver failure, renal failure, or other life-threatening conditions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Cardiovascular Endpoints	5 years	A composite cardiovascular endpoint consisting of ischemic stroke, heart failure hospitalization, and cardiovascular death

Secondary Outcome Measures

Name	Time	Method
New-onset arrhythmia	5 years
New York Heart Association (NYHA) Classification	5 years	Percentage of participants with changes in NYHA classification
Sudden cardiac death (SCD)	5 years
Troponin T/I	5 years	Changes in serum cardiac troponin concentrations compared to baseline
All-cause mortality	5 years	death resulting from any cause, encompassing both disease-related and non-disease-related factors
Cardiovascular death	5 years
Non-fatal acute myocardial infarction	5 years
Ischemic stroke	5 years
Heart failure hospitalization	5 years
Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)	5 years	The KCCQ-23 is a disease-specific health status assessment tool consisting of 23 items that quantify physical limitation, symptoms, self-efficacy, social limitation, and quality of life related to heart failure. Scores range from 0 to 100, with higher scores indicating better health status
BNP/NT-proBNP	5 years	Changes in serum BNP/NT-proBNP concentrations compared to baseline

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China