NCT07054073Recruiting
HCMR Re-Imaging Study
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 314 (estimated)
- First submitted
- 27 Jun 2025
- Start date
- 27 Jul 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Christopher Kramer
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07054073
What you commit to
- Study type: Observational
- Planned participants: 314
- From 27 Jul 2026 to the primary completion date, 31 Mar 2028
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Pregnancy due to potential risk of gadolinium to the fetus
- Patients with a pacemaker that are pacer-dependent as they cannot undergo MRI
Who the study is looking for
- Patients in the original HCMR cohort with:
- 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
- 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%
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Not yet recruiting |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Not yet recruiting |
| Brigham & Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Not yet recruiting |
| Tufts Medical Center Coordinator of this site? Confirm its status | Medford | United States | Not yet recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.