Coronary Flow Reserve in oHCM Patients Before and After 12 Months of Standard-of-care Mavacamten Treatment as Assessed by PET/CT

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The goal of this observational study is to measure the effect of mavacamten treatment on blood flow in the heart muscle (myocardium) in patients with obstructive hypertrophic cardiomyopathy. The main question it aims to answer is: • Does mavacamten treatment improve blood flow in the heart muscle? Participants will take mavacamten at the direction of their treating physician. Participants will complete 2 myocardial Positron Emission Tomography and Computed Tomography (PET-CT) scans. The first scan will be completed before participants start taking mavacamten. The scan will be repeated after 12 months of mavacamten treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
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• Willingness and ability to provide written informed consent

• Willingness and ability to comply with scheduled visits and study procedures

• Male or female, aged 18-85 years

• 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.

• Has been prescribed mavacamten consistent with US Prescribing Information

• Ability and intention to adhere to oral mavacamten therapy as prescribed by treating physician for the duration of study participation

• For females of reproductive potential: negative pregnancy test at screening/baseline and 12 month visits.

Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Time Frame
Start Date: 2023-11-03
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 20
Treatments
Cohort 1
Clinically stable, adult patients with obstructive hypertrophic cardiomyopathy, who meet mavacamten prescribing guidelines will be prescribed mavacamten by their treating physician.
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: Michael Ayers

This content was sourced from clinicaltrials.gov