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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Trial Officials
Samantha Johnson, MPH
Study Director
American Heart Association
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported