Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

NCT06023186 | Recruiting FDA Drug

• 1 other identifier: HSR220293
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

mavacamten DRUG

Study participants will receive mavacamten under the standard of care

Also known as: Camzyos

Cohort 1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Willingness and ability to provide written informed consent
• Willingness and ability to comply with scheduled visits and study procedures
• Male or female, aged 18-85 years
• 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.
• Has been prescribed mavacamten consistent with US Prescribing Information
• Ability and intention to adhere to oral mavacamten therapy as prescribed by treating physician for the duration of study participation
• For females of reproductive potential: negative pregnancy test at screening/baseline and 12 month visits.

You may not qualify if:

• Pregnancy or lactation
• Known hypersensitivity to components of mavacamten or regadenoson
• Prior treatment with mavacamten or aficamten
• \. 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.

Sponsors & Collaborators

• Michael Ayers: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 5, 2023
• Study Start: November 3, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)