Status:
RECRUITING
Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM
Lead Sponsor:
Michael Ayers
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Obstructive Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18-85 years
Brief 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 ...
Detailed Description
This is a single-arm, before-and-after investigation of the effect of mavacamten therapy on myocardial blood flows in adult human subjects prescribed mavacamten for clinical standard of care for oHCM....
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Pregnancy or lactation
- Known hypersensitivity to components of mavacamten or regadenoson
- 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.
Key Trial Info
Start Date :
November 3 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06023186
Start Date
November 3 2023
End Date
September 30 2026
Last Update
November 6 2024
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908