NCT04349072CompletedPhase 3
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction Therapy
Source: ClinicalTrials.gov · Last updated 23 May 2025
Brief summary (registry, in English)
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 therapy (SRT) procedures performed in subjects with symptomatic obstructive hypertrophic cardiomyopathy (oHCM \[also known as HOCM\]) who are eligible for SRT based on ACCF/AHA 2011 and/or ESC 2014 guidelines.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 112 (actual)
- First submitted
- 7 Apr 2020
- Start date
- 6 Jul 2020
- Primary completion date
- 7 Feb 2022
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT04349072
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 112
- From 6 Jul 2020 to the primary completion date, 7 Feb 2022
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 \[ASA\])
- Prior treatment with cardiotoxic agents, such as doxorubicin or similar
Other illness
- Any medical condition that precludes upright exercise stress testing
- 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
Lab values
- 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
Other
- Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at screening
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0006 Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 0020 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 0004 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Local Institution - 0009 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
| Local Institution - 0018 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Local Institution - 0014 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Local Institution - 0015 Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Local Institution - 0011 Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
| Local Institution - 0021 Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
Related publications
- Mavacamten monotherapy in obstructive hypertrophic cardiomyopathy: An integrated analysis of phase 3 clinical trials.Am Heart J · 2027 · PMID 42636950
This page is information, not medical advice. Discuss any trial with your doctor.