A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population

NCT ID: NCT06775665

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2032-06-01

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.

Conditions

Hypertrophic Cardiomyopathy (HCM)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HCM

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.

No interventions were applied to the patients.

Intervention Type: OTHER

No interventions were applied to the patients.

Interventions

No interventions were applied to the patients.

No interventions were applied to the patients.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaojie Xie, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, Zhejiang University School of Medicine

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Jianqiang Song, MD

Role: CONTACT

22318324@zju.edu.cn

+86 15267083207

Shitian Guo, MD

Role: CONTACT

22218352@zju.edu.cn

+86 571-87784700

Facility Contacts

Xiaojie Xie, PhD

Role: primary

xiexj@zju.edu.cn

+86 571-87784700

Other Identifiers

2024-1249

Identifier Type: -

Identifier Source: org_study_id