Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT06023186

Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

Led by Michael Ayers · Updated on 2024-11-06

20

Participants Needed

1

Research Sites

151 weeks

Total Duration

On this page

Sponsors

M

Michael Ayers

Lead Sponsor

B

Bristol-Myers Squibb

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to provide written informed consent
  • Willing and able to follow scheduled visits and study procedures
  • Male or female aged 18 to 85 years
  • Diagnosed with obstructive hypertrophic cardiomyopathy with left ventricular wall thickness ≥15 mm, or ≥13 mm if family history or genotype positive
  • Prescribed mavacamten according to US Prescribing Information
  • Able and intending to follow oral mavacamten therapy as directed
  • For females of childbearing potential: negative pregnancy test at screening and after 12 months
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Known allergy to mavacamten or regadenoson components
  • Previous treatment with mavacamten or aficamten
  • Over weight limit for imaging equipment
  • Left ventricular systolic dysfunction or lung disease that may affect PET/CT image quality

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Virginia

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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