ClinicalTrials.gg
RecruitingNCT07263204Updated Dec 4, 2025

AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy

An observational study in Hypertrophic Cardiomyopathy (HCM) and Left Ventricular Hypertrophy, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
15,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertrophic Cardiomyopathy (HCM)
  • Left Ventricular Hypertrophy
03

In context

Cardiomyopathy, Hypertrophic

363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.

This study's planned enrollment of 15,000 is above the median of 259 across 174 observational studies indexed under Cardiomyopathy, Hypertrophic.

Browse Cardiomyopathy, Hypertrophic studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Patients from whom analyzable data cannot be obtained.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
15,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

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).

    Time frame: year 2

Secondary outcomes

  1. model diagnostic performance

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

    Time frame: year 2

  2. the model's generalizability

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

    Time frame: year 2

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2025 (actual). Primary completion is estimated for Jun 2026, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2025
First posted
Dec 4, 2025
StartActual
Jan 1, 2025
Primary completionEst.
Jun 1, 2026
CompletionEst.
Dec 31, 2026
Last update
Dec 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07263204
Responsible party
Sponsor
First posted
Dec 4, 2025
Start date
Jan 1, 2025
Primary completion
Jun 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 4, 2025

Study contacts

Xiaojie Xie, MD, PhD
Contact
xiexj@zju.edu.cn
(+86)0571-87784700

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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