Tests mavacamten's effect on heart blood flow in obstructive hypertrophic cardiomyopathy
Studies how mavacamten affects blood flow in the heart muscle in people with obstructive cardiomyopathy.
Plain-language title generated from the registry record
Registry title: Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM
Key facts
- Where
- Charlottesville, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06023186, who can take part
Where in United States
- University of VirginiaCharlottesville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Michael Ayers
- Trial code
- NCT06023186
- Record updated
- 6 November 2024
- Original description
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:Read full original descriptionShow less
Coronary Flow Reserve in oHCM Patients Before and After 12 Months of Standard-of-care Mavacamten Treatment as Assessed by PET/CT
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.
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: Prior treatment with mavacamten or aficamten; Known hypersensitivity to components of mavacamten or regadenoson; 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; Pregnancy or lactation.