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Search / Trial NCT06461468

Hypertrophic Cardiomyopathy Federated Learning Implementation Platform

Launched by AMERICAN HEART ASSOCIATION · Jun 13, 2024

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Hcm Hypertrophic Cardiomyopathy Federated Learning Federated Learning Platform Flp

ClinConnect Summary

HCM FLIP (Hypertrophic Cardiomyopathy Federated Learning Implementation Platform) aim to build and test a model's system impact to detect hypertrophic cardiomyopathy (HCM) by training a machine learning (ML) model with electrocardiograms (ECGs) and echocardiograms (ECHOs). Approximately 10-1000 HCM cases and 30-10,000 age/sex-matched controls per institution, depending on size, will be included in the study. We hypothesize that a federated ML model will discriminate cases of HCM from those without HCM in a real-world setting.

Gender

ALL

Eligibility criteria

  • HCM-Labeled Case Inclusion Criteria:
  • Patients with maximum left ventricular wall thickness exceeding 15 mm (including the right ventricular component of the septum) without any other explanation for ventricular hypertrophy (e.g., severe hypertension, cardiac amyloidosis, severe AS, as determined by local investigators). The measurement could be made in an ECHO or on magnetic resonance imaging (MRI).
  • Patients must have \> one (1) ECG and/or \> one (1) ECHO available that meet minimum compatibility requirements. If multiple ECGs and ECHOs are available per patient, then all available data meeting compatibility requirements will be used for model training purposes.
  • HCM-Labeled Case Exclusion Criteria:
  • Any sign of infiltration found in cardiac MRI, if performed.
  • Control Case (Non-HCM) Inclusion Criteria:
  • No diagnosis of HCM
  • Age/sex are matched to HCM cases (+/- 5 years, if possible; +/- 10 years if numbers do not permit).
  • Patient must have \> one (1) ECG and/or \> one (1) ECHO available that meet minimum compatibility requirements. If multiple ECGs and ECHOs are available per patient, then all available data meeting compatibility requirements will be used for model training purposes.
  • Control Case (Non-HCM) Exclusion Criteria
  • Suggestion of HCM in a clinically obtained ECHO or cardiac MRI report unless subsequently confirmed no diagnosis of HCM. Any new clinical information discovered during the study will be left to the discretion of the local investigator.

About American Heart Association

The American Heart Association (AHA) is a leading non-profit organization dedicated to advancing cardiovascular health through research, education, and advocacy. With a mission to reduce the prevalence of heart disease and stroke, the AHA sponsors a range of clinical trials aimed at improving patient outcomes and advancing scientific knowledge in cardiovascular medicine. By fostering collaboration among healthcare professionals, researchers, and communities, the AHA plays a pivotal role in shaping public health policies and promoting evidence-based practices that enhance the quality of care for individuals affected by cardiovascular conditions. Through its commitment to rigorous research and innovation, the AHA continues to be at the forefront of efforts to combat heart disease and improve the overall health of populations.

Locations

Ann Arbor, Michigan, United States

Baltimore, Maryland, United States

Fairhope, Alabama, United States

Dallas, Texas, United States

Kankakee, Illinois, United States

Wooster, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Samantha Johnson, MPH

Study Director

American Heart Association

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported