Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM (MavaPET)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Intervention / Treatment: Drug: mavacamten

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Contact: Caroline L Flournoy; Phone Number: 434-924-6104; Email: clf4w@uvahealth.org
      • Principal Investigator: Michael Ayers, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Clinically stable adult obstructive hypertrophic cardiomyopathy patients on background therapy who have been prescribed Camzyos (mavacamten) in accordance with the US Prescribing Information, but who have not yet started this medication.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in myocardial perfusion reserve after 12 months of mavacamten treatment.	Myocardial perfusion reserve is the ratio of global myocardial blood flow at stress versus rest.	12 months

Collaborators and Investigators

• Sponsor: Michael Ayers
• Collaborators: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: HSR220293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data on individual participants will be shared outside the University of Virginia.

Drug and device information, study documents

• 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