Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

Launched by MICHAEL AYERS · Aug 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called mavacamten affects blood flow in the heart muscle of patients with a condition known as obstructive hypertrophic cardiomyopathy (oHCM). The main question being studied is whether taking mavacamten can improve blood flow in the heart. Participants in this study will take mavacamten as prescribed by their doctor and will undergo two special heart scans (called PET-CT scans) – one before starting the medication and another after 12 months of treatment.

To participate, individuals need to be between the ages of 18 and 85 and have a diagnosis of obstructive hypertrophic cardiomyopathy. They also need to be willing to follow the study's procedures and take the medication as directed. It's important to note that pregnant or breastfeeding women, as well as those with certain health conditions, cannot join the study. Overall, participants can expect to play an important role in helping researchers understand how mavacamten impacts heart health over time.

Gender

ALL

Eligibility 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.