NOT_YET_RECRUITING
Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM
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.
Conditions:
🦠 Obstructive Hypertrophic Cardiomyopathy
🗓️ Study Start (Actual) 15 September 2023
🗓️ Primary Completion (Estimated) 1 December 2026
✅ Study Completion (Estimated) 1 December 2026
👥 Enrollment (Estimated) 20
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Charlottesville, Virginia, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 August 2023
  • First Submitted that Met QC Criteria 28 August 2023
  • First Posted 5 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 August 2023
  • Last Update Posted 5 September 2023
  • Last Verified August 2023