NCT06023186Recruiting
Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM
Coronary Flow Reserve in oHCM Patients Before and After 12 Months of Standard-of-care Mavacamten Treatment as Assessed by PET/CT
Source: ClinicalTrials.gov · Last updated 6 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 28 Aug 2023
- Start date
- 3 Nov 2023
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Michael Ayers
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT06023186
What you commit to
- Study type: Observational
- Planned participants: 20
- From 3 Nov 2023 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Known hypersensitivity to components of mavacamten or regadenoson
Other
- Pregnancy or lactation
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.