Actively Recruiting
HCMR Re-Imaging Study
Led by Christopher Kramer · Updated on 2026-03-18
314
Participants Needed
8
Research Sites
65 weeks
Total Duration
On this page
Sponsors
C
Christopher Kramer
Lead Sponsor
B
Brigham and Women's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HCMR Re-Imaging Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients previously enrolled in the original HCMR cohort
- Diagnosed with obstructive or non-obstructive hypertrophic cardiomyopathy
- Age between 18 and 65 years
- For obstructive HCM: BMI less than 35 kg/m2
- For obstructive HCM: Resting left ventricular outflow tract gradient (LVOT-G) ≥50 mmHg OR resting LVOT-G ≥30 mmHg and <50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
- For obstructive HCM: New York Heart Association (NYHA) Class II or III
- For non-obstructive HCM: Same criteria except resting LVOT-G <30 mmHg and post-Valsalva gradient <50 mmHg
- For non-obstructive HCM: BMI less than 40 kg/m2
- For non-obstructive HCM: Elevated NT-proBNP >300 pg/mL at enrollment
- For non-obstructive HCM: Left ventricular ejection fraction (LVEF) ≥55%
You will not qualify if you...
- Documented paroxysmal atrial fibrillation or flutter before entering the study
- Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment within 6 months before entry, unless treated with anticoagulation and adequately rate-controlled for more than 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
- Pacemaker-dependent patients who cannot undergo MRI
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
Northwestern
Evanston, Illinois, United States, 60208
Not Yet Recruiting
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
3
Tufts Medical Center
Medford, Massachusetts, United States, 02155
Not Yet Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
5
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
6
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
7
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW
Not Yet Recruiting
8
London Chest Hospital
London, United Kingdom, E2 9JX
Not Yet Recruiting
Research Team
G
Gina Duda
CONTACT
T
Thuy Le
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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