| NCT ID | NCT07054073 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Christopher Kramer |
| Condition | Hypertrophic Cardiomyopathy (HCM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 314 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 314 participants in total. It began in 2026-03-30 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Christopher Kramer, MD
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT07054073 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hypertrophic Cardiomyopathy (HCM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07054073 currently recruiting?
Yes, NCT07054073 is actively recruiting participants. Contact the research team at gms4x@uvahealth.org for enrollment information.
Where is the NCT07054073 trial being conducted?
This trial is being conducted at Evanston, United States, Boston, United States, Medford, United States, Ann Arbor, United States and 4 additional locations.
Who is sponsoring the NCT07054073 clinical trial?
NCT07054073 is sponsored by Christopher Kramer. The principal investigator is Christopher Kramer, MD at University of Virginia. The trial plans to enroll 314 participants.