Hypertrophic CardiomyopathyHCM FLIPNCT06461468
Hypertrophic Cardiomyopathy Federated Learning Implementation Platform
An observational study of Hypertrophic Cardiomyopathy, run by American Heart Association at 6 sites in United States.
Trial summary
HCM FLIP study is a two-phase protocol focusing on the detection of Hypertrophic Cardiomyopathy using Electrocardiograms and Echocardiograms through Federated Learning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 1,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 5 Jun 2024to Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Enrollment Target: Phase 1: Approximately 10-100 HCM cases and 30-10,000 age/sex-matched controls per institution, depending on size, will be included in the study. Since a larger sample size benefits training ML models, additional cases could be included based on availability within each institution. Phase 2: Institution-specific cohort of patients (see Section 7.4.2) to simulate implementation of the algorithm; natural case control ratio and consecutive patients for identified period of time. The numbers of patients will be dependent on the volume of each institution and should reflect the local practice.
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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Thomas Hospital
Fairhope, Alabama, 36532
Riverside Medical Center
Kankakee, Illinois, 60901
Wooster Community Hospital
Wooster, Ohio, 44691
About this study
Official title: Detection of Hypertrophic Cardiomyopathy Using Electrocardiograms and Echocardiograms Through Federated Learning
HCM FLIP study is a two-phase protocol focusing on the detection of Hypertrophic Cardiomyopathy using Electrocardiograms and Echocardiograms through Federated Learning.
Read the detailed description
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.
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- HCM, Hypertrophic Cardiomyopathy, Federated Learning, Federated Learning Platform, FLP
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCM-Labeled Cases | Cases 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 aortic stenosis (AS)). The measurement could be made in an echocardiogram or on magnetic resonance imaging (MRI). | |
| Control Cases (Non-HCM) | No diagnosis of HCM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of HCM
The number/instances of HCM diagnoses as identified by the ML model as compared to clinical diagnosis confirmation. Due to model training and efficacy goals, HCM diagnosis determined clinically via EKG/ECHO reading will be compared to the ML model's capacity to identify HCM correctly and efficiently.
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
Diagnosis of different types of HCM
Diagnosis of different types of HCM (i.e., apical, obstructive), HCM without hypertrophy, genetic positive/negative indicators, among others, as identified by the ML model as compared to clinical diagnosis confirmation. Due to model training and efficacy goals, HCM diagnosis determined clinically via EKG/ECHO reading will be compared to the ML model's capacity to identify HCM correctly and efficiently.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start5 Jun 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Heart Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samantha Johnson, MPH, Study director, American Heart Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461468
- Sponsor's protocol ID
- HCM FLIP
- Acronym
- HCM FLIP
- Status last verified
- Aug 2024
- First submitted
- 4 Jun 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data is identifiable nor will be shared across participating institutions.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Hypertrophic Cardiomyopathy Using Electrocardiograms and Echocardiograms Through Federated Learning
- ClinicalTrials.gov ID
- NCT06461468
- Acronym / sponsor ID
- HCM FLIP / HCM FLIP
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- HCM, Hypertrophic Cardiomyopathy, Federated Learning, Federated Learning Platform, FLP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- American Heart AssociationUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HCM FLIP study is a two-phase protocol focusing on the detection of Hypertrophic Cardiomyopathy using Electrocardiograms and Echocardiograms through Federated Learning.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCM-Labeled Cases | – | –Cases 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 aortic stenosis (AS)). The measurement could be made in an echocardiogram or on magnetic resonance imaging (MRI). |
| Control Cases (Non-HCM) | – | –No diagnosis of HCM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollment Target: Phase 1: Approximately 10-100 HCM cases and 30-10,000 age/sex-matched controls per institution, depending on size, will be included in the study. Since a larger sample size benefits training ML models, additional cases could be included based on availability within each institution. Phase 2: Institution-specific cohort of patients (see Section 7.4.2) to simulate implementation of the algorithm; natural case control ratio and consecutive patients for identified period of time. The numbers of patients will be dependent on the volume of each institution and should reflect the local practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of HCM
Time frame: Through study completion, an average of 2 years
The number/instances of HCM diagnoses as identified by the ML model as compared to clinical diagnosis confirmation. Due to model training and efficacy goals, HCM diagnosis determined clinically via EKG/ECHO reading will be compared to the ML model's capacity to identify HCM correctly and efficiently.
1 secondary outcome
Diagnosis of different types of HCM
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No. No participant data is identifiable nor will be shared across participating institutions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Johnson, MPH study director
American Heart Association
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by American Heart Association at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of HCM (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.