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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
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

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 0006
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Ann ArborUnited StatesUnknown status
Local Institution - 0016
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BostonUnited StatesUnknown status
Local Institution - 0007
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BostonUnited StatesUnknown status
Local Institution - 0020
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ClevelandUnited StatesUnknown status
Local Institution - 0004
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DurhamUnited StatesUnknown status
Local Institution - 0013
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Grand RapidsUnited StatesUnknown status
Local Institution
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HoustonUnited StatesUnknown status
Local Institution - 0009
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Los AngelesUnited StatesUnknown status
Local Institution - 0012
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MurrayUnited StatesUnknown status
Local Institution - 0018
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NashvilleUnited StatesUnknown status
Local Institution - 0014
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NashvilleUnited StatesUnknown status
Local Institution - 0001
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New HavenUnited StatesUnknown status
Local Institution - 0010
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New YorkUnited StatesUnknown status
Local Institution - 0003
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PhiladelphiaUnited StatesUnknown status
Local Institution - 0019
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PittsburghUnited StatesUnknown status
Local Institution - 0002
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PortlandUnited StatesUnknown status
Local Institution - 0015
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RochesterUnited StatesUnknown status
Local Institution - 0011
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StanfordUnited StatesUnknown status
Local Institution - 0005
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St LouisUnited StatesUnknown status
Local Institution - 0017
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ValhallaUnited StatesUnknown status
Local Institution - 0021
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WestonUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.