Clinical trial NCT06775665: A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population
Official title: Clinical Characteristics and Real-World Outcomes of Chinese Patients With Hypertrophic Cardiomyopathy: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypertrophic Cardiomyopathy (HCM)
Keywords: hypertrophic cardiomyopathy
real-world study
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hypertrophic cardiomyopathy

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Composite Cardiovascular Endpoints
timeFrame: 5 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: 5 years
measure: Cardiovascular death
timeFrame: 5 years
measure: New-onset arrhythmia
timeFrame: 5 years
measure: Sudden cardiac death (SCD)
timeFrame: 5 years
measure: Non-fatal acute myocardial infarction
timeFrame: 5 years
measure: Ischemic stroke
timeFrame: 5 years
measure: Heart failure hospitalization
timeFrame: 5 years
measure: New York Heart Association (NYHA) Classification
timeFrame: 5 years
measure: Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)
timeFrame: 5 years
measure: BNP/NT-proBNP
timeFrame: 5 years
measure: Troponin T/I
timeFrame: 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, Zhejiang University School of Medicine
name: Xiaojie Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References: