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Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM | Clinical Trials | Clareo Health

RECRUITING

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

NCT06023186•Michael Ayers

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Key Dates

Start Date

November 3, 2023

Primary Completion Date

August 31, 2026

Completion Date

September 30, 2026

Last Updated

November 6, 2024

Enrollment

ESTIMATED participants

Conditions

Obstructive Hypertrophic Cardiomyopathy

Interventions

mavacamten

DRUG

A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy

NCT07021976

Obstructive Hypertrophic Cardiomyopathy

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NOT_YET_RECRUITINGNA

Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

NCT06856265

Obstructive Hypertrophic CardiomyopathyMavacamten+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

Inclusion Criteria

Exclusion Criteria

A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy

Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Left Ventricular Mass Index Predicts Clinical Outcomes in Patients with Obstructive Hypertrophic Cardiomyopathy Undergoing Septal Myectomy

A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM

Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy

Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy