HCMR Re-Imaging Study
ConditionHypertrophic Cardiomyopathy (HCM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorChristopher Kramer
About this trial
This study aims to learn what might predict heart problems (like sudden death from a fast heart rhythm or heart failure) in people with a genetic condition called hypertrophic cardiomyopathy (HCM). HCM causes the heart muscle to become thick, which can make the heart stiff and harder to work properly. It can also affect the heart's electrical system.
This study is looking to enroll patients that were previously part of a research project called "HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy." The results of that study are still being reviewed, but they might show that people who had a substance called Gadolinium (MRI contrast or dye) collected in their heart muscle may have a higher risk for heart problems, including sudden cardiac death. This is called "late gadolinium enhancement" (LGE). This study is aiming to do follow-up imaging on those patients to better understand how LGE affects people with HCM.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Obstructive HCM
Males and females between 18 and 65 years of age
BMI < 35 kg/m2
Non-obstructive HCM
Disqualifiers
Paroxysmal atrial fibrillation or flutter documented prior to entry.
Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months prior to entry. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months.)
History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to entry.
Pregnancy due to potential risk of gadolinium to the fetus
Trial population
Participants from the HCMR original cohort who also meet this study's eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
None - observational study
Other interventionNone - observational study
Treatment groups
314 Participants
are divided into 2 treatment groupsGroup A: Obstructive HCM1 intervention
Group B: Non-obstructive HCM1 intervention
Trial outcomes
Primary outcomes
1
Change in % LGE mass
To assess the change in LGE extent from baseline over a minimum of 7 years of follow-up extent in HCM patients who would have been candidates for clinical trials of aficamten.
Time frame
From baseline over a minimum of 7 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Christopher Kramer
Lead sponsor
University of Virginia
Sponsor institution
Brigham and Women's Hospital
Collaborator
Mayo Clinic
Collaborator
Tufts Medical Center
Collaborator
Northwestern University
Collaborator
University of Michigan
Collaborator
The Cleveland Clinic
Collaborator
University Hospital Birmingham NHS Foundation Trust
Collaborator
Glenfield Hospital, Leicester
Collaborator
London Chest Hospital
Collaborator
Cytokinetics
Collaborator
Toronto General Hospital
Collaborator
Source ClinicalTrials.gov