Mavacamten for Hypertrophic Cardiomyopathy
(COMPASS-HCM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how mavacamten, a medication, affects people with obstructive hypertrophic cardiomyopathy, a condition where the heart muscle thickens and obstructs blood flow, causing symptoms like shortness of breath. Participants will report changes in their health status while using this treatment. Suitable candidates have been prescribed mavacamten but have not used it for more than seven days. This trial excludes those who have recently undergone major heart or lung surgeries, experienced heart attacks or strokes, or have severe lung disease affecting daily activities.
As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for mavacamten?
Research has shown that mavacamten is generally safe for people with obstructive hypertrophic cardiomyopathy (oHCM), a condition where the heart muscle thickens and can block blood flow. Studies have found that long-term use of mavacamten does not introduce new safety issues. In earlier trials, patients noticed improvements in heart function and symptoms without major side effects.
A review of several studies found that most people tolerate mavacamten well. While all medications can have side effects, current evidence suggests that the benefits of mavacamten in treating oHCM outweigh the risks. It is important to consult a healthcare professional to understand what this might mean for individual circumstances.12345Why are researchers enthusiastic about this study treatment?
Mavacamten is unique because it specifically targets the underlying cause of obstructive hypertrophic cardiomyopathy (HCM) by modulating cardiac myosin, the motor protein that drives heart muscle contraction. Unlike standard treatments like beta-blockers or calcium channel blockers, which mainly address symptoms, mavacamten directly addresses the excessive contractility of the heart muscle. This targeted approach has the potential to improve heart function and reduce symptoms more effectively, making researchers excited about its potential to transform the management of HCM.
What evidence suggests that mavacamten might be an effective treatment for obstructive hypertrophic cardiomyopathy?
Studies have shown that mavacamten, which participants in this trial will receive, works well for people with obstructive hypertrophic cardiomyopathy, a condition where the heart muscle becomes too thick. Research indicates that long-term use of mavacamten leads to lasting improvements in heart function and symptoms. Patients using mavacamten in everyday life experienced fewer heart-related problems. Another study found that patients noticed their symptoms improved. Overall, mavacamten has proven to be both effective and safe over long periods.23678
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mavacamten for symptomatic obstructive hypertrophic cardiomyopathy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mavacamten
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Adult participants with symptomatic obstructive hypertrophic cardiomyopathy treated with mavacamten
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
Long-term effect of mavacamten in obstructive hypertrophic ...
Long-term mavacamten treatment resulted in sustained improvements in cardiac function and symptoms in patients with obstructive HCM, with no new safety ...
Eighteen‐Month Real‐World Experience Using ...
Mavacamten was effective and safe when used under real‐world conditions in a racially diverse population of symptomatic patients with obstructive hypertrophic ...
Clinical Outcomes With Mavacamten Use in Patients ...
In this nationwide study leveraging real-world data, mavacamten therapy was associated with a lower risk of adverse cardiovascular outcomes in ...
Long-term safety and efficacy of mavacamten in obstructive ...
Long-term mavacamten treatment in patients with obstructive HCM resulted in sustained improvements in echocardiographic measures, symptoms, and ...
Efficacy and safety of Mavacamten for symptomatic ...
On random effect model, we found that HCM patients that received Mavacamten had significant symptomatic improvement as depicted by improvement in NYHA class by ...
Abstract 4134320: Integrated safety and tolerability of ...
Long-term data of mavacamten are available from multiple studies, providing the opportunity to further understand mavacamten long term safety, ...
Safety and Efficacy of Mavacamten and Aficamten in ...
Using a systematic search, 10 clinical trials with safety and efficacy data for either drug in obstructive hypertrophic cardiomyopathy (oHCM) ...
Safety and Effectiveness of Mavacamten Use in ...
Safety and Effectiveness of Mavacamten Use in Hypertrophic Obstructive Cardiomyopathy: A Systematic Review and Meta-Analysis ... safety data ...
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