Mavacamten for Hypertrophic Cardiomyopathy
(ODYSSEY-HCM Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the drug Mavacamten for treating hypertrophic cardiomyopathy?
Research shows that Mavacamten, a drug approved by the FDA, improves symptoms and exercise capacity in patients with obstructive hypertrophic cardiomyopathy by reducing heart muscle obstruction. Clinical trials found it more effective than a placebo in improving heart function and reducing the need for surgical interventions.12345
Is mavacamten safe for humans?
Mavacamten, also known as Camzyos or MYK-461, has been studied in clinical trials for hypertrophic cardiomyopathy and was generally well tolerated, with some patients experiencing serious adverse events. It was approved by the FDA in April 2022, indicating that its benefits outweigh the risks for this condition, but full safety information is available on the FDA's website.23467
What makes the drug Mavacamten unique for treating hypertrophic cardiomyopathy?
Mavacamten is unique because it is a first-of-its-kind drug that directly targets the heart's muscle fibers by inhibiting myosin, which helps reduce the excessive contraction of the heart muscle seen in hypertrophic cardiomyopathy. Unlike other treatments that mainly address symptoms, Mavacamten works at the root cause by modulating the heart's muscle function.12689
What is the purpose of this trial?
This trial is testing a new medication called mavacamten to see if it is safe and effective for people with a heart condition that makes their heart muscle too thick. The goal is to help their heart work better and improve their symptoms.
Research Team
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
This trial is for people with a heart condition called non-obstructive hypertrophic cardiomyopathy (nHCM). Participants should have significant thickening of the heart muscle, experience symptoms, and fall under specific classifications of heart function. They can't join if they've had unexplained fainting or dangerous irregular heartbeats recently, or if their condition might be due to another disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mavacamten or placebo to evaluate safety, tolerability, and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Mavacamten
- Placebo
Mavacamten is already approved in United States, European Union, Canada, Switzerland, Brazil for the following indications:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
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