Last updated on December 2018

Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation


Brief description of study

STUDY OBJECTIVES Primary objective(s) To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation.

Secondary objectives To evaluate the effect of macitentan 10 mg as compared to placebo on cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD implantation.

To evaluate the safety and tolerability of macitentan 10 mg in subjects with PH after LVAD implantation.

Exploratory objectives To explore the potential effect of macitentan 10 mg as compared to placebo on right ventricular function in subjects with PH after LVAD implantation.

To explore the potential effect of macitentan 10 mg as compared to placebo on selected clinical events in subjects with PH after LVAD implantation.

To explore the potential effect of macitentan 10 mg as compared to placebo on renal function as measured by glomerular filtration rate (GFR) in subjects with PH after LVAD implantation.

Clinical Study Identifier: NCT02554903

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Robert Scott, MD

#125_Mayo Clinic Arizona
Phoenix, AZ United States
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Jennifer Cook, MD

#144_University of Arizona
Tucson, AZ United States
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Jaime Moriguchi, MD

#106_Cedars-Sinai Medical Center
Beverly Hills, CA United States
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Eric Adler, MD

#154_University of California San Diego
La Jolla, CA United States
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John Chin, MD

#110_Sutter Heart Institute
Sacramento, CA United States
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Munir Janmohamed, MD

#132_University of California San Francisco
San Francisco, CA United States
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David Majure, MD

#123_MedStar Washington Hospital Center
Washington, WA United States
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Scott Silvestry, MD

#126_Florida Hospital
Orlando, FL United States
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Valluvan Jeevanandam, MD

#135_University of Chicago Medical Center
Chicago, IL United States
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Antone Tatooles, MD

#113_Advocate Christ Medical Center
Oak Lawn, IL United States
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Marco Caccamo, DO

#108_Indiana University Health Physicians Cardiology
Indianapolis, IN United States
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Ashwin Ravichandran, MD

#112_St. Vincent Medical Group, Inc
Indianapolis, IN United States
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Vladimir Cotarlan-Nistor, MD

#120_University of Iowa Hospitals and Clinics
Iowa City, IA United States
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Maya Guglin, MD

#152_University of Kentucky
Lexington, KY United States
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Emma Birks, MD

#117_University of Louisville
Louisville, KY United States
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Stacy Mandra, MD

#105_Ochsner Medical Center
New Orleans, LA United States
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Ryan Tedford, MD

#129_John Hopkins University Medical Center
Baltimore, MD United States
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Amanda Vest, MD

#143_Tufts Medical Center
Boston, MA United States
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Greg Lewis, MD

#138_Massachusetts General Hospital
Boston, MA United States
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Michael Givertz, MD

#119_Brigham and Women's Hospital
Boston, MA United States
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Mona Selej, MD

#115_Henry Ford Hospital
Detroit, MI United States
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Robert Frantz, MD

#102_Mayo Clinic
Rochester, MN United States
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Mark Everley, MD

#150_Saint Luke's Hospital
Kansas City, MO United States
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Ronald Zolty, MD

#131_University of Nebraska Medical Center
Omaha, NE United States
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Ulrich Jorde, MD

#133_Montefiore Medical Center
Bronx, NY United States
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Evelyn Horn, MD

#103_Weill Cornell Medical College
New York, NY United States
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Raymond Bietry, MD

#139_Icahn School of Medicine at Mount Sinai
New York, NY United States
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Jean Elwing, MD

#148_University of Cincinnati Medical Center
Cincinnati, OH United States
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Miriam Jacob, MD

#153_Cleveland Clinic
Cleveland, OH United States
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Veronica Franco, MD

#101_The Ohio State University Wexner Medical Center
Columbus, OH United States
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Mark Bonnell

#145_The University of Toledo Medical Center
Toledo, OH United States
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Doug Horstmanshof, MD

#121_Integris Baptist Medical Center
Oklahoma City, OK United States
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David Silber, MD

#142_Penn State Heart and Vascular Institute
Hershey, PA United States
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Jeremy Mazurek, MD

#140_Hospital of the University of Pennsylvania
Philadelphia, PA United States
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Richard Agarwal, MD

#134_Allegheny General Hospital
Pittsburgh, PA United States
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Jeffery Teuteberg, MD

#130_University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Patrick J McCann, MD

#141_Palmetto Health / Palmetto Heart
Columbia, SC United States
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Jawwad Yusuf, MD

#151_Stern Cardiovascular Foundation
Memphis, TN United States
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Mary Keebler, MD

#146_Vanderbilt University Medical Center
Nashville, TN United States
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Ernest Haeusslein, MD

#149_Seton Heart Institute
Austin, TX United States
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Shelley Hall, MD

#136_Baylor Health - Baylor University Medical Center
Dallas, TX United States
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Myung Park, MD

#107_Houston Methodist Hospital
Houston, TX United States
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Chandra Kunavarapu, VM

#122_Advanced Heart Failure Clinic - HCM
San Antonio, TX United States
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Edward Gilbert, MD

#127_The University of Utah
Salt Lake City, UT United States
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Jamie Kennedy, MD

#114_University of Virginia
Charlottesville, VA United States
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Shashank Desai, MD

#111_Inova Fairfax Hospital
Falls Church, VA United States
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Melissa Smallfield, MD

#116_Virginia Commonwealth University (VCU) Medical Center
Richmond, VA United States
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Shane LaRue, MD

#104_Washington University School of Medicine
Saint Louis, MO United States
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Gregg Lanier, MD

#147_Westchester Medical Center
Valhalla, NY United States
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Brian Houston

Medical University of South Carolina
Charleston, SC United States
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Ravi Dhingra

#155_University of Wisconsin Hospital and Clinics
Madison, WI United States
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Recruitment Status: Open


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