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 |
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.
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
Bethlehem, Pennsylvania 18018
Principal Investigator: Jamshid Shirani, MD
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75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
![Brigham and Women's Hosp](/wp-content/uploads/logos/brigham-and-women-s-hosp.jpg)
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
![Carolinas Medical Center](/wp-content/uploads/logos/carolinas-medical-center.jpg)
Principal Investigator: John Symanski, MD
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![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
234 Goodman Dr
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
(513) 584-1000
![University of Cincinnati Medical Center](/wp-content/uploads/logos/university-of-cincinnati-medical-center.jpg)
Principal Investigator: Richard Becker, MD
University of Cincinnati Medical Center Opening in 1823 as the country
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5323 Harry Hines Blvd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 648-3111
![UT Southwestern Medical Center](/wp-content/uploads/logos/univ-of-texas-southwestern-med-ctr-of-dallas.jpg)
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
Portland, Oregon 97239
503 494-8311
![Oregon Health and Science University](/wp-content/uploads/logos/oregon-health-and-science-university.jpg)
Principal Investigator: Stephen Heitner, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Principal Investigator: Sharlene Day, MD
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Baltimore, Maryland 21201
Principal Investigator: Libin Wang, MD
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Charlottesville, Virginia 22903
(434) 924-0311
![University of Virginia](/wp-content/uploads/logos/university-of-virginia.png)
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
Detroit, Michigan 48202
(313) 916-2600
![Henry Ford Hospital](/wp-content/uploads/logos/henry-ford-hospital.png)
Principal Investigator: Karthikeyan Ananthasubramaniam, MD
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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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
![Houston Methodist Hospital](/wp-content/uploads/logos/houston-methodist-hospital.jpg)
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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Indianapolis, Indiana 46290
Principal Investigator: Ashwin Ravichandran, MD
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200 Hawkins Dr,
Iowa City, Iowa 52242
Iowa City, Iowa 52242
866-452-8507
![University of Iowa Hospitals and Clinics](/wp-content/uploads/logos/university-of-iowa-hospitals-and-clinics.jpg)
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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Los Angeles, California 90048
Principal Investigator: Florian Rader, MD
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Madison, Wisconsin 53713
Principal Investigator: John Moses, MD
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259 1st Street
Mineola, New York 11501
Mineola, New York 11501
Principal Investigator: Ramesh Daggubati, MD
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5121 S Cottonwood St
Murray, Utah 84157
Murray, Utah 84157
(801) 507-7000
![Intermountain Medical Center](/wp-content/uploads/logos/intermountain-medical-center.jpg)
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
New Haven, Connecticut 06520
(203) 688-4242
![Yale-New Haven Hospital](/wp-content/uploads/logos/yale-new-haven-hospital.jpg)
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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Palo Alto, California 94305
Principal Investigator: Matthew Wheeler, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
![Univ of Pennsylvania](/wp-content/uploads/logos/univ-of-pennsylvania.jpg)
Principal Investigator: Anjali Owens, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Richmond, Virginia 23298
(804) 828-0100
![Virginia Commonwealth University](/wp-content/uploads/logos/virginia-commonwealth-university.jpg)
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
![Washington University School of Medicine](/wp-content/uploads/logos/washington-university-school-of-medicine.png)
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
Scottsdale, Arizona 85259
480-301-8000
![Mayo Clinic Arizona](/wp-content/uploads/logos/mayo-clinic-arizona.png)
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
Seattle, Washington 98195
(206) 598-3300
![University of Washington Medical Center](/wp-content/uploads/logos/university-of-washington-medical-center.jpg)
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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