NCT07336290

Brief Summary

This is a multi-center, observational study aiming to establish a precision diagnosis scheme and multi-dimensional risk prediction models for Hypertrophic Cardiomyopathy (HCM). The study plans to enroll 10000 adult HCM patients. It will integrate genetic testing, advanced cardiac imaging (echocardiography and cardiac magnetic resonance), and biomarker analysis to develop early diagnosis, differential diagnosis, and new risk prediction models for sudden cardiac death (SCD) and heart failure in HCM patients. Participants will undergo baseline assessments and be followed up every six months for up to 3 years to track clinical outcomes. This study is non-interventional and does not involve any investigational drugs or devices.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2010

Longer than P75 for all trials

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2010Dec 2030

Study Start

First participant enrolled

January 1, 2010

Completed
16 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2028

Expected
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

January 28, 2026

Status Verified

January 1, 2025

Enrollment Period

18.6 years

First QC Date

January 2, 2026

Last Update Submit

January 27, 2026

Conditions

Hypertrophic Cardiomyopathy (HCM)

Keywords

cardiac magnetic resonancediagnosisrisk stratificaitonartificial intelligencepersonalized prognosis

Outcome Measures

Primary Outcomes (1)

  • Number of participants with sudden cardiac death

    5-year

Secondary Outcomes (3)

  • Number of participants with all-cause mortality

    5-year

  • Number of participants with atrial fibrillation

    5-year

  • Number of participants with heart failure hospitalization

    5-year

Study Arms (1)

hypertrophic myocardium

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with hypertrophic myocardium experienced CMR scanning

You may qualify if:

  • A maximal left ventricular wall thickness of ≥ 12 mm in any segment at end-diastole, as measured by echocardiography or Cardiac Magnetic Resonance (CMR)

You may not qualify if:

  • Presence of any contraindication to CMR examination.
  • Unwillingness to participate in the study or to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicDisease

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 13, 2026

Study Start

January 1, 2010

Primary Completion (Estimated)

July 30, 2028

Study Completion (Estimated)

December 30, 2030

Last Updated

January 28, 2026

Record last verified: 2025-01