Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

NCT ID: NCT06023186

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-03
• Study Completion Date: 2026-09-30

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.

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.

Conditions

Obstructive Hypertrophic Cardiomyopathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

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

mavacamten

Intervention Type: DRUG

Study participants will receive mavacamten under the standard of care

Interventions

mavacamten

Study participants will receive mavacamten under the standard of care

Intervention Type: DRUG

Other Intervention Names

Camzyos

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Michael Ayers

OTHER

Sponsor Role: lead

Responsible Party

Michael Ayers

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Caroline L Flournoy

Role: primary

clf4w@uvahealth.org

434-924-6104

Other Identifiers

HSR220293

Identifier Type: -

Identifier Source: org_study_id