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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04349072
Date of registration: 07/04/2020
Prospective Registration: Yes
Primary sponsor: MyoKardia, Inc.
Public title: A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy VALOR-HCM
Scientific title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction Therapy
Date of first enrolment: June 26, 2020
Target sample size: 100
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04349072
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Myokardia Medical Information Team
Address: 
Telephone: 6507410900
Email: medinfo@myokardia.com
Affiliation: 
Key inclusion & exclusion criteria

Key Inclusion Criteria:

- At least 18 years old at screening and body weight > 45 kg at screening

- Diagnosed with oHCM consistent with current ACCF/AHA 2011 and/or ESC 2014 guidelines
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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
HOCM, Hypertrophic Obstructive Cardiomyopathy
Intervention(s)
Drug: Mavacamten
Drug: Placebo
Primary Outcome(s)
Septal Reduction Therapy (SRT) Status [Time Frame: 16 Weeks]
Secondary Outcome(s)
Mavacamten effect on KCCQ [Time Frame: 16 Weeks]
Mavacamten effect on LVOT gradient [Time Frame: 16 Weeks]
Mavacamten effect on NT-proBNP [Time Frame: 16 Weeks]
Mavacamten effect on NYHA [Time Frame: 16 Weeks]
SRT Status [Time Frame: 32 Weeks]
Secondary ID(s)
MYK-461-017
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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