Recruiting

Hypertrophic Cardiomyopathy

Sponsor:

Christopher Kramer

Code:

NCT07054073

Conditions

Hypertrophic Cardiomyopathy (HCM)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

None - observational study

Study Details

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.

Conditions

Hypertrophic Cardiomyopathy (HCM)

Study ID

NCT07054073

Start date

Mar 30, 2026

Status verified date

Mar, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

314 participants

Anticipated

Interventions and Outcome Measures

Arms

Obstructive HCM

Non-obstructive HCM

Interventions

None - observational study

None - observational study

Primary outcome measure

  • Change in % LGE mass [ Time Frame: From baseline over a minimum of 7 years ]

Central Contacts and Locations

Central contacts

Gina Duda

434-924-9553gms4x@uvahealth.org

Thuy Le

DZV5SQ@uvahealth.org

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Niki Sprouse

434-982-1058NJB6M@uvahealth.org

More Information

Sponsor

Christopher Kramer

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christopher Kramer on 2026-03-18.