Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorMichael Ayers
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy or lactation
Known hypersensitivity to components of mavacamten or regadenoson
Prior treatment with mavacamten or aficamten
Trial population
Clinically stable adult obstructive hypertrophic cardiomyopathy patients on background therapy who have been prescribed Camzyos (mavacamten) in accordance with the US Prescribing Information, but who have not yet started this medication.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
mavacamten
DrugStudy participants will receive mavacamten under the standard of care
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Cohort 11 intervention
Trial outcomes
Primary outcomes
1
Change in myocardial perfusion reserve after 12 months of mavacamten treatment.
Myocardial perfusion reserve is the ratio of global myocardial blood flow at stress versus rest.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov