NCT06023186

Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Michael Ayers · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	mavacamten	Study participants will receive mavacamten under the standard of care

Timeline

• Start date: 2023-11-03
• Primary completion: 2026-08-31
• Completion: 2026-09-30
• First posted: 2023-09-05
• Last updated: 2024-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study