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Myosin Inhibitor

Mavacamten for Hypertrophic Cardiomyopathy

Phase 3
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of HCM
Presence of LVOT obstruction
Must not have
Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 1 and week 11
Awards & highlights

Summary

This trial aims to test how well mavacamten works, how safe it is, and how the body processes it in teenagers with a specific heart condition called obstructive hypertrophic cardiomyopathy.

Who is the study for?
This trial is for adolescents with obstructive hypertrophic cardiomyopathy (HCM) who show symptoms. Specific details about eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a specific level of disease severity.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of a drug called Mavacamten compared to a placebo in young patients with HCM. It also looks at how the body processes the drug.See study design
What are the potential side effects?
While specific side effects are not listed, common ones for heart medications like Mavacamten could include dizziness, changes in blood pressure or heart rhythm, fatigue, and potential liver enzyme abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with hypertrophic cardiomyopathy (HCM).
Select...
My heart has a blockage in the outflow tract.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My heart muscle thickening is not due to sarcomere dysfunction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 1 and week 11
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 and week 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Valsalva left ventricular outflow tract (LVOT) (VLVOT) gradient
Secondary outcome measures
Area under the concentration-time curve (AUC)
Change from baseline in electrocardiogram (ECG) (QT interval)
Change from baseline in maximal wall thickness
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Participants assigned to this arm will receive mavacamten from week 28 to end of treatment at week 56.
Group II: MavacamtenExperimental Treatment1 Intervention
Participants assigned to this arm will receive mavacamten from day 1 to end of treatment at week 56.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Mavacamten
2022
Completed Phase 1
~340

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,652 Previous Clinical Trials
4,130,709 Total Patients Enrolled
~27 spots leftby Feb 2028
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