HCMR Re-Imaging Study

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

Qualifiers

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 design

Treatments tested in this trial

  • None - observational study

Treatment groups

314 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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