Actively Recruiting
Coronary Flow Reserve in oHCM Patients Before and After 12 Months of Standard-of-care Mavacamten Treatment as Assessed by PET/CT
Led by Michael Ayers · Updated on 2024-11-06
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
M
Michael Ayers
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the impact of mavacamten treatment on blood flow in the heart muscle of adults with obstructive hypertrophic cardiomyopathy (oHCM). The study aims to find out if taking mavacamten improves blood flow in the heart muscle over time. Participants are adults diagnosed with oHCM who have been prescribed mavacamten as part of their normal medical care. Participants will take mavacamten under the guidance of their treating physician according to standard care. The study involves one group of patients who will have two heart scans using Positron Emission Tomography and Computed Tomography (PET-CT). The first scan is done before starting mavacamten, and the second scan is done after 12 months of treatment to observe any changes. During the study, participants will undergo PET/CT scans before and after one year of mavacamten therapy. Researchers will measure changes in myocardial perfusion reserve, which reflects blood flow in the heart muscle. Participants must follow their treatment plan and attend scheduled visits for scans and assessments. The total involvement lasts about 12 months, with careful monitoring to ensure quality imaging and adherence to therapy.
CONDITIONS
Brief Title
Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with left ventricular wall thickness 615 mm or 613 mm if genotype positive or family history
- Prescribed mavacamten consistent with US Prescribing Information
- Ability and intention to adhere to oral mavacamten therapy during the study
- For females of reproductive potential: negative pregnancy test at screening and 12 months
You will not qualify if you...
- Pregnancy or lactation
- Known hypersensitivity to mavacamten or regadenoson
- Prior treatment with mavacamten or aficamten
- Over weight limit for imaging gantry
- Presence of left ventricular systolic dysfunction or lung disease that may affect PET/CT imaging quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 week before treatment starts
Participants undergo myocardial PET/CT imaging before starting mavacamten therapy to assess baseline myocardial blood flow.
1 visit (in-person)
Duration - 12 months
Participants take mavacamten as prescribed by their physician under standard care for 12 months.
Visits as per routine clinical care; imaging assessments not required during treatment
Duration - Within 1 month after 12 months of treatment
Participants undergo myocardial PET/CT imaging after 12 months of mavacamten therapy to assess changes in myocardial blood flow.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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