| Registry | NCT07054073 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 314 (Estimated) |
| Sponsor | Christopher Kramer (Other); collaborators: Brigham and Women's Hospital, Mayo Clinic, Tufts Medical Center, Northwestern University, University of Michigan, The Cleveland Clinic, University Hospital Birmingham NHS Foundation Trust, Glenfield Hospital, Leicester, London Chest Hospital, Cytokinetics, Toronto General Hospital |
| Conditions | Hypertrophic Cardiomyopathy (HCM) |
| Interventions | None - observational study (Other) |
| Dates | start 2026-07-27, primary completion 2028-03-01 (estimated), completion 2028-07-01 (estimated), first posted 2025-07-08, last updated 2026-10-16 |
| Locations | 8 sites in United States, United Kingdom |
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All trials for Hypertrophic Cardiomyopathy (HCM) All trials of None - observational study
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Obstructive HCM | Other: None - observational study | ||
| Non-obstructive HCM | Other: None - observational study |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: Patients in the original HCMR cohort with: 1. Obstructive HCM * Males and females between 18 and 65 years of age * BMI < 35 kg/m2 * LVOT-G at entry as follows: Resting gradient ≥50 mmHg OR Resting gradient ≥30 mmHg and <50 mmHg with post-Valsalva LVOT-G ≥50 mmHg • NYHA Class II or III or 2. Non-obstructive HCM * Same criteria as above except resting LVOT-G is <30mmHg and post-Valsalva gradient <50mm Hg * BMI <40kg/m2 * Elevated NT-proBNP > 300 pg/mL at the time of enrollment * LVEF ≥55% Exclusion Criteria: * 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 * Patients with a pacemaker that are pacer-dependent as they cannot undergo MRI
| Facility | City | Country | Status |
|---|---|---|---|
| Brigham & Women's Hospital | Boston, Massachusetts | United States | Not yet recruiting |
| Tufts Medical Center | Medford, Massachusetts | United States | Not yet recruiting |
| University of Michigan | Ann Arbor, Michigan | United States | Not yet recruiting |
| Mayo Clinic | Rochester, Minnesota | United States | Recruiting |
| Cleveland Clinic | Cleveland, Ohio | United States | Not yet recruiting |
| University of Virginia | Charlottesville, Virginia | United States | Recruiting |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom | Not yet recruiting |
| Barts Health NHS Trust | London | United Kingdom | Recruiting |