Effect of mavacamten on heart blood flow in obstructive hypertrophic cardiomyopathy
Coronary Flow Reserve in oHCM Patients Before and After 12 Months of Standard-of-care Mavacamten Treatment as Assessed by PET/CT
This study is testing if the medication mavacamten can improve blood flow in the hearts of people with obstructive hypertrophic cardiomyopathy after a year of treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06023186 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of mavacamten treatment on blood flow in the heart muscle of patients diagnosed with obstructive hypertrophic cardiomyopathy (oHCM). Participants will receive mavacamten as prescribed by their physician and will undergo two myocardial PET-CT scans: one before starting treatment and another after 12 months of therapy. The study seeks to determine if mavacamten improves myocardial blood flow, providing insights into its effectiveness for this condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-85 diagnosed with obstructive hypertrophic cardiomyopathy who are prescribed mavacamten.
Not a fit: Patients with conditions that do not involve obstructive hypertrophic cardiomyopathy or those not prescribed mavacamten may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with obstructive hypertrophic cardiomyopathy by enhancing blood flow in the heart muscle.
How similar studies have performed: While this approach is focused on a specific treatment for oHCM, similar studies have shown promising results in improving cardiac function with other therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Willingness and ability to provide written informed consent 2. Willingness and ability to comply with scheduled visits and study procedures 3. Male or female, aged 18-85 years 4. Diagnosed with obstructive hypertrophic cardiomyopathy according to presence of a left ventricular wall thickness of ≥15 mm that is otherwise unexplained by abnormal loading conditions (e.g., hypertension, valvular, congenital disease) or infiltrative cardiomyopathies. Unexplained left ventricular wall thickness of ≥13 mm is sufficient for diagnosis in relatives of individuals with hypertrophic cardiomyopathy or those who are genotype positive. 5. Has been prescribed mavacamten consistent with US Prescribing Information 6. Ability and intention to adhere to oral mavacamten therapy as prescribed by treating physician for the duration of study participation 7. For females of reproductive potential: negative pregnancy test at screening/baseline and 12 month visits. Exclusion Criteria: 1. Pregnancy or lactation 2. Known hypersensitivity to components of mavacamten or regadenoson 3. Prior treatment with mavacamten or aficamten 11\. Over weight limit for imaging gantry. 12. To minimize the risk of participants undergoing PET/CT with inadequate image quality, participants with left ventricular systolic dysfunction or lung disease will be excluded.
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
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.