A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No interventions were applied to the patients..
- Who it may be relevant to
- Registry conditions: Hypertrophic Cardiomyopathy (HCM). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Characteristics and Real-World Outcomes of Chinese Patients With Hypertrophic Cardiomyopathy: A Prospective Cohort Study
Overview
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.
Interventions
- Other No interventions were applied to the patients.
No interventions were applied to the patients.
Primary outcome measures
- Composite Cardiovascular Endpoints [Time frame: 5 years]
Secondary outcome measures (11)
- All-cause mortality [Time frame: 5 years]
- Cardiovascular death [Time frame: 5 years]
- New-onset arrhythmia [Time frame: 5 years]
- Sudden cardiac death (SCD) [Time frame: 5 years]
- Non-fatal acute myocardial infarction [Time frame: 5 years]
- Ischemic stroke [Time frame: 5 years]
- Heart failure hospitalization [Time frame: 5 years]
- New York Heart Association (NYHA) Classification [Time frame: 5 years]
- Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) [Time frame: 5 years]
- BNP/NT-proBNP [Time frame: 5 years]
- Troponin T/I [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou
Identifiers
NCT: NCT06775665 · 2024-1249