Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

Last updated: November 4, 2024
Sponsor: Michael Ayers
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Treatment

mavacamten

Clinical Study ID

NCT06023186
HSR220293
  • Ages 18-85
  • All Genders

Study Summary

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

Inclusion

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 aleft ventricular wall thickness of ≥15 mm that is otherwise unexplained by abnormalloading conditions (e.g., hypertension, valvular, congenital disease) orinfiltrative cardiomyopathies. Unexplained left ventricular wall thickness of ≥13 mmis sufficient for diagnosis in relatives of individuals with hypertrophiccardiomyopathy 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 treatingphysician for the duration of study participation

  7. For females of reproductive potential: negative pregnancy test at screening/baselineand 12 month visits.

Exclusion

Exclusion Criteria:

  1. Pregnancy or lactation

  2. Known hypersensitivity to components of mavacamten or regadenoson

  3. Prior treatment with mavacamten or aficamten

  4. Over weight limit for imaging gantry. 12. To minimize the risk of participantsundergoing PET/CT with inadequate image quality, participants with left ventricularsystolic dysfunction or lung disease will be excluded.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: mavacamten
Phase:
Study Start date:
November 03, 2023
Estimated Completion Date:
September 30, 2026

Study Description

This is a single-arm, before-and-after investigation of the effect of mavacamten therapy on myocardial blood flows in adult human subjects prescribed mavacamten for clinical standard of care for oHCM. We hypothesize that 12 months of mavacamten therapy will improve myocardial blood flows as assessed by PET/CT. The investigation will take place at a single site. Participants who consent will be prospectively enrolled once mavacamten therapy has been approved by their health insurance/payer. Enrolled participants will undergo myocardial PET/CT before starting mavacamten and after 12 months of therapy.

Connect with a study center

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

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