HCMR Re-Imaging for Hypertrophic Cardiomyopathy Follow-up
HCMR Re-Imaging Study
We will do follow-up heart MRI scans to see if gadolinium scarring (LGE) predicts future dangerous heart rhythms or heart failure in adults who were in the original HCMR cohort and have hypertrophic cardiomyopathy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 314 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 8 sites (Evanston, Illinois and 7 other locations) |
| Trial ID | NCT07054073 on ClinicalTrials.gov |
What this trial studies
This observational follow-up enrolls participants from the original HCMR cohort to repeat cardiac MRI with gadolinium and compare imaging findings to clinical outcomes. The study focuses on measuring late gadolinium enhancement (LGE) and other MRI markers of fibrosis and structure, then tracking arrhythmias, heart failure events, and related complications. No experimental treatments are given; investigators will collect imaging and clinical data and analyze associations between imaging features and subsequent risk. The goal is to refine which imaging signs best predict adverse events in people with HCM.
Who should consider this trial
Good fit: Adults aged 18–65 with hypertrophic cardiomyopathy who previously participated in the original HCMR cohort and meet the original cohort's BMI, obstruction, NT-proBNP, and LVEF criteria are ideal candidates.
Not a fit: People who were not in the original HCMR cohort, those with recent or excluded atrial fibrillation or other listed exclusions, or anyone who cannot have a gadolinium-enhanced MRI are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could help doctors identify HCM patients at higher risk for dangerous heart rhythms or heart failure using MRI scarring, enabling more targeted monitoring and preventive care.
How similar studies have performed: Prior cohort studies, including data from the original HCMR and other HCM cohorts, have linked late gadolinium enhancement to worse outcomes, but prospective re-imaging to refine individual risk prediction is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Evanston, Illinois and 7 other locations
- Northwestern — Evanston, Illinois, United States (Not_yet_recruiting)
- 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)
- 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)
- London Chest Hospital — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Christopher Kramer, MD — University of Virginia
- Study coordinator: Gina Duda
- Email: gms4x@uvahealth.org
- Phone: 434-924-9553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.