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NCT Number: NCT07263204

AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Xiaojie Xie, MD, PhD

CONTACT

[email protected]

(+86)0571-87784700

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

Patients from whom analyzable ECG data cannot be obtained.

Treatment and study plan

Primary outcomes

  1. model diagnostic performance

    Time frame: year 2

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

Secondary outcomes

  1. model diagnostic performance

    Time frame: year 2

    The accuracy rate of the model's phenotype-specific classification for patients with different patterns of myocardial hypertrophy

  2. the model's generalizability

    Time frame: year 2

    The model's diagnostic performance on the external, multicentre validation cohort, including overall accuracy, sensitivity, specificity, and area under the ROC curve (AUC).

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaojie Xie, MD, PhD

CONTACT

[email protected]

(+86)0571-87784700

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Precision Diagnosis and Prognostic Prediction of Hypertrophic Cardiomyopathy Using Artificial Intelligence: A Multicenter Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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