A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)



Status:Recruiting
Conditions:Cardiology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:March 30, 2018
End Date:July 2019
Contact:MyoKardia Medical Information Team
Email:medinfo@myokardia.com
Phone:(650) 741-0900

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A Randomized, Double-blind, Placebo-controlled, Concentration-guided, Exploratory Study of Mavacameten in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) and Preserved Left Ventricular Ejection Fraction

This is a multicenter, exploratory, randomized, double-blind study of the administration of
mavacamten in 60 participants with symptomatic nHCM randomized to receive a 16-week course of
mavacamten doses titrated to achieve 1 of 2 target drug concentrations.


Key Inclusion Criteria:

- Diagnosed with nHCM (hypertrophied and non-dilated left ventricle in absence of
systemic or other known cause), with LV wall thickness ≥ 15mm at Screening or ≥ 13mm
with a positive family history of HCM.

- Age 18 and greater, Body weight ≥ 45kg

- Documented LVEF ≥ 55% at the Screening as determined by echo central lab

- LVOT gradient < 30 mmHg at rest AND during Valsalva AND post-exercise

- NYHA functional class II or III

- Elevated NT-proBNP at rest

Key Exclusion Criteria:

- History of syncope, sustained ventricular tachyarrhythmia with exercise, obstructive
coronary artery disease or myocardial infarction within the past 6 months

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

- Current treatment with disopyramide or ranolazine (within 14 days prior to Screening)

- Current or planned treatment during the study with a combination of beta-blockers and
calcium channel blockers

- Has been treated with invasive septal reduction (surgical myectomy or percutaneous
alcohol septal ablation [ASA]) within 6 months prior to Screening

- History of resting or post-exercise LVOT >30 mmHg unless subsequently treated by
septal reduction

- Has QTc Fridericia (QTcF) >480 ms or any other ECG abnormality considered by the
investigator to pose a risk to participant safety (eg, second-degree atrioventricular
block type II)

- Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4
weeks prior to Screening and/or not adequately rate-controlled within 1 year of
Screening

- History of clinically significant malignant disease within 10 years such as
non-metastatic cutaneous squamous cell or basal cell carcinoma

- History or evidence of any other clinically significant disorder, condition, or
disease that, in the opinion of the investigator or MyoKardia physician, would pose a
risk to subject safety or interfere with the study evaluation, procedures, or
completion.
We found this trial at
32
sites
Indianapolis, Indiana 46290
Principal Investigator: Ashwin Ravichandran, MD
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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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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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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: Richard Becker, MD
University of Cincinnati Medical Center Opening in 1823 as the country
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Cincinnati, OH
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Aslan Turer, MD
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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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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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Principal Investigator: Sharlene Day, MD
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Ann Arbor, MI
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Baltimore, Maryland 21201
Principal Investigator: Libin Wang, MD
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Bethlehem, Pennsylvania 18018
Principal Investigator: Jamshid Shirani, MD
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Bethlehem, PA
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Christopher Kramer, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Karthikeyan Ananthasubramaniam, MD
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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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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Evanston, Illinois 60208
Principal Investigator: Lubna Choudhury, MD
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Evanston, IL
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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, Texas 77030
Principal Investigator: Ali Marian, MD
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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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Los Angeles, California 90048
Principal Investigator: Florian Rader, MD
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Los Angeles, CA
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Madison, Wisconsin 53713
Principal Investigator: John Moses, MD
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Madison, WI
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259 1st Street
Mineola, New York 11501
Principal Investigator: Ramesh Daggubati, MD
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Mineola, NY
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Principal Investigator: Kia Afshar, MD
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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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 York, New York 10016
Principal Investigator: Mark Sherrid, MD
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Palo Alto, California 94305
Principal Investigator: Matthew Wheeler, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Anjali Owens, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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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
(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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Salt Lake City, Utah 84132
Principal Investigator: Omar Wever-Pinzon, MD
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San Francisco, California 94143
Principal Investigator: Theodore Abraham, MD
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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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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: David Owens, MD
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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