A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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.

Trial population

Patients with hypertrophic cardiomyopathy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No interventions were applied to the patients.

    Other intervention

    No interventions were applied to the patients.

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: HCM1 intervention

Trial outcomes

Primary outcomes

1

Composite Cardiovascular Endpoints

Number of Participants with a composite cardiovascular endpoint consisting of ischemic stroke, heart failure hospitalization, and cardiovascular death

Time frame
5 years

Secondary outcomes

1

All-cause mortality

Rate of death resulting from any cause, encompassing both disease-related and non-disease-related factors

Time frame
5 years
2

Cardiovascular death

Rate of death resulting from cardiac diseases

Time frame
5 years
3

New-onset arrhythmia

Number of Participants with new-onset arrhythmia

Time frame
5 years
4

Sudden cardiac death (SCD)

Number of Participants suffer from sudden cardiac death

Time frame
5 years

Other outcomes

Sponsors and contacts

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