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MavaPET: Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

Sponsor
Michael Ayers (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06023186
Collaborator
Bristol-Myers Squibb (Industry)
20
Enrollment
1
Location
38.5
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Coronary Flow Reserve in oHCM Patients Before and After 12 Months of Standard-of-care Mavacamten Treatment as Assessed by PET/CT
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Cohort 1

Clinically stable, adult patients with obstructive hypertrophic cardiomyopathy, who meet mavacamten prescribing guidelines will be prescribed mavacamten by their treating physician.

Drug: mavacamten
Study participants will receive mavacamten under the standard of care
Other Names:
  • Camzyos

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in myocardial perfusion reserve after 12 months of mavacamten treatment. [12 months]

      Myocardial perfusion reserve is the ratio of global myocardial blood flow at stress versus rest.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    4. 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

    Locations

    Site City State Country Postal Code
    1 University of Virginia Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • Michael Ayers
    • Bristol-Myers Squibb

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Ayers, Assistant Professor, University of Virginia
    ClinicalTrials.gov Identifier:
    NCT06023186
    Other Study ID Numbers:
    • HSR220293
    First Posted:
    Sep 5, 2023
    Last Update Posted:
    Sep 5, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Cardiomyopathies
    Cardiomyopathy, Hypertrophic

    Study Results

    No Results Posted as of Sep 5, 2023