Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy



Status:Recruiting
Conditions:Cardiology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:May 29, 2018
End Date:June 2020
Contact:MyoKardia Medical Information Team
Email:medinfo@myokardia.com
Phone:(650) 741-0900

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A Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

This is a multicenter, international, double-blind study of the administration of mavacamten
in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will
be randomized to receive placebo or mavacamten.


Key Inclusion Criteria:

- Age 18 and greater, body weight ≥ 45kg

- Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)

- Diagnosed with oHCM consistent with current American College of Cardiology
Foundation/American Heart Association and European Society of Cardiology guidelines
and satisfy both criteria:

- Has documented left ventricular ejection fraction (LVEF) ≥55%

- NYHA Class II or III

- Has documented oxygen saturation at rest ≥90% at Screening

- Is able to perform an upright CPET and has a respiratory exchange ratio (RER) ≥1.0 at
Screening per central reading

- LVOT gradient with Valsalva maneuver >=30 mmHg at Screening determined by
echocardiography core lab

Key Exclusion Criteria:

- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM,
such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy

- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6
months prior to Screening

- History of resuscitated sudden cardiac arrest (at any time) or known history of
appropriate implantable cardioverter defibrillator (ICD) discharge for
life-threatening ventricular arrhythmia within 6 months prior to Screening

- Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at
Screening

- Persistent or permanent atrial fibrillation not on anticoagulation for at least 4
weeks prior to Screening and/or not adequately rate controlled within 6 months prior
to Screening

- Treatment (within 14 days prior to Screening) or planned treatment during the study
with disopyramide or ranolazine

- Treatment (within 14 days prior to Screening) or planned treatment during the study
with a combination of β-blockers and calcium channel blockers

- LVOT gradient with Valsalva maneuver <30 mmHg at Screening

- Has been successfully treated with invasive septal reduction (surgical myectomy or
percutaneous alcohol septal ablation [ASA]) within 6 months prior to Screening or
plans to have either of these treatments during the study

- ICD placement within 6 months prior to Screening or planned ICD placement during the
study

- Has a history or evidence of any other clinically significant disorder, condition, or
disease that, in the opinion of the investigator, would pose a risk to participant
safety or interfere with the study evaluation, procedures, or completion

- Prior treatment with cardiotoxic agents such as doxorubicin or similar
We found this trial at
28
sites
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Matthew Wheeler, MD
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Neal Lakdawala, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: John Symanski, MD
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Charlotte, NC
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Richard Becker, MD
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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Houston, Texas 77030
Principal Investigator: Ali Marian, MD
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Houston, TX
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Stephen Heitner, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Aalst, Oost-Vlaanderen
Principal Investigator: Jozef Bartunek, MD
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Aalst,
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Sara Saberi, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
Principal Investigator: Libin Wang, MD
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Baltimore, MD
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Bethlehem, Pennsylvania 18018
Principal Investigator: Jamshid Shirani, MD
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Bethlehem, PA
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Christopher Kramer, MD
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Charlottesville, VA
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Aslan Turer, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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6301 Herndon Road
Durham, North Carolina 27713
Principal Investigator: Andrew Wang, MD
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Durham, NC
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500 University Drive
Hershey, Pennsylvania 17033
Principal Investigator: Eric Popjes, MD
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Hershey, PA
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Sherif Nagueh, MD
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Houston, TX
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Paulino Alvarez, MD
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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4500 San Pablo Road South
Jacksonville, Florida 32224
Principal Investigator: Mohamad Yamani, MD
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Jacksonville, FL
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Los Angeles, California 90048
Principal Investigator: Florian Rader, MD
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Los Angeles, CA
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Daniel Jacoby, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Haven, CT
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New York, New York 10016
Principal Investigator: Mark Sherrid, MD
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New York, NY
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Mathew Maurer, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Philadelphia, Pennsylvania 19104
Principal Investigator: Anjali T Owens, MD
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Timothy Wong, MD
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Pittsburgh, PA
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Keyur Shah, MD
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Richard Bach, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Salt Lake City, Utah 84157
Principal Investigator: Kia Afshar, MD
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Salt Lake City, UT
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San Francisco, California 94143
Principal Investigator: Theodore Abraham, MD
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San Francisco, CA
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Steven Lester, MD
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Scottsdale, AZ
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