RECRUITING

Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

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Conditions

Obstructive Hypertrophic Cardiomyopathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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: • 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.

Official Title

Coronary Flow Reserve in oHCM Patients Before and After 12 Months of Standard-of-care Mavacamten Treatment as Assessed by PET/CT

Quick Facts

Study Start:2023-11-03
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06023186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Willingness and ability to provide written informed consent
  2. 2. Willingness and ability to comply with scheduled visits and study procedures
  3. 3. Male or female, aged 18-85 years
  4. 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. 5. Has been prescribed mavacamten consistent with US Prescribing Information
  6. 6. Ability and intention to adhere to oral mavacamten therapy as prescribed by treating physician for the duration of study participation
  7. 7. For females of reproductive potential: negative pregnancy test at screening/baseline and 12 month visits.
  1. 1. Pregnancy or lactation
  2. 2. Known hypersensitivity to components of mavacamten or regadenoson
  3. 3. Prior treatment with mavacamten or aficamten
  4. 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.

Contacts and Locations

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: Michael Ayers

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

Study Start Date2023-11-03
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-11-03
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Obstructive Hypertrophic Cardiomyopathy