AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardio... | NCT07263204

Studies
AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy

NCT07263204

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Recruiting

Last Update Posted

Dec 4, 2025Actual

Enrollment

15,000Estimated

Phase

Not provided

Conditions

Hypertrophic Cardiomyopathy (HCM)
Left Ventricular Hypertrophy

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Nov 17, 2025

First Submission Date that Met QC Criteria

Nov 23, 2025

First Posted Date

Dec 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2025

Last Update Posted Date

Dec 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
model diagnostic performance	The accuracy rate of the model's phenotype-specific classification for patients with different patterns of myocardial hypertrophy	year 2
the model's generalizability

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaojie Xie, MD, PhD	Contact	(+86)0571-87784700		xiexj@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second Affiliated Hospital, Zhejiang University School of Medicine	Recruiting	Hangzhou	Zhejiang	310009	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002312	Cardiomyopathy, Hypertrophic
D017379	Hypertrophy, Left Ventricular

Ancestor Terms

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001020	Aortic Stenosis, Subvalvular

Browse Leaves

Not provided

Browse Branches

Not provided