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 |
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.
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
75 Francis street
Boston, Massachusetts 02115
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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1000 Blythe Blvd
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: John Symanski, MD
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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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Houston, Texas 77030
Principal Investigator: Ali Marian, MD
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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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500 S State St
Ann Arbor, Michigan 48109
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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655 West Baltimore Street
Baltimore, Maryland 21201
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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Bethlehem, Pennsylvania 18018
Principal Investigator: Jamshid Shirani, MD
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1215 Lee St
Charlottesville, Virginia 22903
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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1801 Inwood Rd
Dallas, Texas 75390
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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6301 Herndon Road
Durham, North Carolina 27713
Durham, North Carolina 27713
Principal Investigator: Andrew Wang, MD
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500 University Drive
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
Principal Investigator: Eric Popjes, MD
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6550 Fannin St
Houston, Texas 77030
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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200 Hawkins Dr,
Iowa City, Iowa 52242
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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4500 San Pablo Road South
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Principal Investigator: Mohamad Yamani, MD
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Los Angeles, California 90048
Principal Investigator: Florian Rader, MD
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20 York St, N20 York St,
New Haven, Connecticut 06520
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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630 W 168th St
New York, New York
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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Philadelphia, Pennsylvania 19104
Principal Investigator: Anjali T Owens, MD
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Timothy Wong, MD
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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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660 S Euclid Ave
Saint Louis, Missouri 63110
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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San Francisco, California 94143
Principal Investigator: Theodore Abraham, MD
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
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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450 Serra Mall
Stanford, California 94305
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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