AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy

NCT07263204 | Recruiting

• 1 other identifier: 2024-1546
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

By harnessing artificial intelligence to decode the 12-lead electrocardiogram, the project will enable precise ECG-based phenotyping of hypertrophic cardiomyopathy-accurately classifying septal, apical, and other morphologic subtypes-while simultaneously differentiating HCM from hypertensive heart disease, aortic stenosis, and other phenocopy disorders.

Conditions

Hypertrophic Cardiomyopathy (HCM); Left Ventricular Hypertrophy

Outcome Measures

Primary Outcomes (1)

• model diagnostic performance

  Model performance was evaluated using calculated metrics including accuracy, sensitivity, specificity, and the area under the ROC curve (AUC).

  year 2

Secondary Outcomes (2)

• model diagnostic performance

  year 2

• the model's generalizability

  year 2

Study Arms (3)

HCM

diagnosed with hypertrophic cardiomyopathy by echocardiography and cardiac magnetic resonance imaging

phenocopy

patients with left-ventricular hypertrophy attributable to non-hypertrophic cardiomyopathy conditions

normal control

healthy individuals without myocardial hypertrophy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. HCM cohort: Adults diagnosed with hypertrophic cardiomyopathy in accordance with the \*2023 Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy in Adults\*. 2. HCM phenocopy cohort: Adults with an LV wall thickness ≥ 13 mm at any site on echocardiography. 3. Healthy-control cohort: Adults with no history of cardiac disease and no evidence of myocardial hypertrophy on echocardiography.

You may qualify if:

• Adults aged ≥ 18 years.
• HCM cohort: Adults diagnosed with hypertrophic cardiomyopathy in accordance with the \*2023 Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy in Adults\*.
• HCM phenocopy cohort: Adults with an LV wall thickness ≥ 13 mm at any site on echocardiography.
• Healthy-control cohort: Adults with no history of cardiac disease and no evidence of myocardial hypertrophy on echocardiography.

You may not qualify if:

• Patients from whom analyzable ECG data cannot be obtained.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Cardiomegaly; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaojie Xie, MD, PhD

CONTACT

(+86)0571-87784700; xiexj@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 4, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)