AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy

Zhejiang University

Status: Enrolling

Conditions: Left Ventricular Hypertrophy; Hypertrophic Cardiomyopathy (HCM)

Study type: Observational

Funder types: Other

Identifiers

NCT07263204

2024-1546

Details and patient eligibility

About

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.

Full description

To overcome the twin bottlenecks of late detection and poor inter-centre reproducibility, the project leverages a large, multicentre historical cohort and anchors its pipeline on the 12-lead ECG-an inexpensive, ubiquitously available signal that can be captured in any department. Using deep-learning architectures augmented with attention mechanisms, we will develop (1) a discriminative model that separates HCM from phenocopies and normal hearts, and (2) an algorithmic framework that remains stable across devices and populations. Model governance will be embedded through version-controlled releases, cloud-edge deployment, and an "offline replay" evaluation loop, producing an end-to-end evidence chain that mirrors real-world clinical workflows.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Patients from whom analyzable ECG data cannot be obtained.

Trial design

15,000 participants in 3 patient groups

HCM

Description:

diagnosed with hypertrophic cardiomyopathy by echocardiography and cardiac magnetic resonance imaging

phenocopy

Description:

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

normal control

Description:

healthy individuals without myocardial hypertrophy