NCT06775665

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
73mo left

Started Jun 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2032

Last Updated

May 30, 2025

Status Verified

January 1, 2025

Enrollment Period

4.6 years

First QC Date

January 9, 2025

Last Update Submit

May 25, 2025

Conditions

Hypertrophic Cardiomyopathy (HCM)

Keywords

hypertrophic cardiomyopathyreal-world study

Outcome Measures

Primary Outcomes (1)

  • Composite Cardiovascular Endpoints

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

    5 years

Secondary Outcomes (11)

  • All-cause mortality

    5 years

  • Cardiovascular death

    5 years

  • New-onset arrhythmia

    5 years

  • Sudden cardiac death (SCD)

    5 years

  • Non-fatal acute myocardial infarction

    5 years

  • +6 more secondary outcomes

Study Arms (1)

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.

Other: No interventions were applied to the patients.

Interventions

No interventions were applied to the patients.OTHER

No interventions were applied to the patients.

HCM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hypertrophic cardiomyopathy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Xiaojie Xie, PhD

    Second Affiliated Hospital, Zhejiang University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianqiang Song, MD

CONTACT

+86 1526708320722318324@zju.edu.cn

Shitian Guo, MD

CONTACT

+86 571-8778470022218352@zju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 15, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

June 1, 2032

Last Updated

May 30, 2025

Record last verified: 2025-01

Locations

CN(1)