A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population (HCM)

Zhejiang University

Status: Begins enrollment in 3 months

Conditions: Hypertrophic Cardiomyopathy (HCM)

Treatments: Other: No interventions were applied to the patients.

Study type: Observational

Funder types: Other

Identifiers

NCT06775665

2024-1249

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 1 patient group

HCM

Description:

Patients diagnosed with hypertrophic cardiomyopathy (HCM) according to the 2023 Guideline for Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy were consecutively enrolled. These patients received pharmacological, interventional, or surgical treatment based on real-world treatment strategies. Follow-up was conducted to observe patient prognosis and the occurrence of outcome events.

Treatment:

Other: No interventions were applied to the patients.