Status:
COMPLETED
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HOCM, Hypertrophic Obstructive Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction ...
Eligibility Criteria
Inclusion
- Key
- At least 18 years old at screening and body weight \> 45 kg at screening
- Diagnosed with oHCM consistent with current ACCF/AHA 2011 and meet their recommendations for invasive therapies
- Referred or under active consideration within the past 12 months for SRT procedure and willing to have SRT procedure
- Has documented left ventricular ejection fraction (LVEF) ≥ 60% at Screening
- Has documented oxygen saturation at rest ≥ 90% at Screening
- Key
Exclusion
- Persistent or permanent atrial fibrillation and subject not on anticoagulation for ≥ 4 weeks prior to screening and/or not adequately rate controlled ≤ 6 months prior to screening
- Previously treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\])
- For individuals on beta blockers, calcium channel blockers, or disopyramide, any dose adjustment of these medications \< 14 days prior to screening or an anticipated change in regimen during the first 16 weeks of the study
- Any medical condition that precludes upright exercise stress testing
- Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at screening
- Prior treatment with cardiotoxic agents, such as doxorubicin or similar
- Has a history or evidence of any other clinically significant disorder, condition, or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2024
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04349072
Start Date
July 6 2020
End Date
May 20 2024
Last Update
May 23 2025
Active Locations (21)
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1
Local Institution - 0009
Los Angeles, California, United States, 90027
2
Local Institution - 0011
Stanford, California, United States, 94305 5406
3
Local Institution - 0001
New Haven, Connecticut, United States, 06520
4
Local Institution - 0021
Weston, Florida, United States, 33331