Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 79
Updated:3/8/2019
Start Date:August 15, 2017
End Date:December 2021
Contact:David B Yehle, RPh
Email:dyehle@unither.com
Phone:919 485-8350

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Trial Summary
Trial Overview
Inclusion Criteria

An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301

This is an open-label study to evaluate the safety of continued therapy with oral
treprostinil in subjects who have completed Study TDE-HF-301. This study will provide
long-term, open-label data regarding the effect of continued long-term oral treprostinil
therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with
preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18,
24, and every 12 weeks thereafter until either oral treprostinil becomes commercially
available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.


Inclusion Criteria:

- The subject participated in Study TDE-HF-301, remained on study drug, was compliant
with study procedures and assessments during Study TDE-HF-301, and completed through
Week 24 of that study.

Exclusion Criteria

- The subject is pregnant or lactating.

- The subject was prematurely discontinued from Study TDE-HF-301 for any reason.

- The subject developed a concurrent illness or condition during Study TDE HF 301,
which, in the opinion of the Investigator, would represent a risk to the subject's
overall health if they enrolled in this study.
We found this trial at
82
sites
Montefiore Medical Center
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Sandhya Murthy, MD
Phone: 718-920-8780
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Indranee Rajapreyar, MD
Phone: 205-975-9426
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Brigham and Women's Hosp
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Aaron Waxman, MD
Phone: 617-525-9731
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Tufts Medical Center
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Ioana Preston, MD
Phone: 617-636-1334
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Miriam Jacob
Phone: 216-445-1630
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Baylor University Medical Center
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Yolanda Mageto, MD
Phone: 214-820-5829
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University of Texas Health Science Center at Houston
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Bela Patel, MD
Phone: 713-500-6851
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University of Kentucky Medical Center
740 South Limestone Street
Lexington, Kentucky 40536
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Cedars-Sinai Medical Center
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Antoine Hage, MD
Phone: 310-248-7141
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Univ of Minnesota
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Thenappan Thenappan, MD
Phone: 612-626-6237
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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Mount Sinai Hospital
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: Sean Pinney, MD
Phone: 212-241-7403
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Central Florida Pulmonary Group, PA
326 North Mills Avenue
Orlando, Florida 32803
Principal Investigator: Hadi Chohan, MD
Phone: 407-426-9299
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Cleveland Clinic Florida
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Principal Investigator: Jinesh Mehta, MD
Phone: 954-659-6213
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Albany Medical College
47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: Boris Medarov, MD
Phone: 518-262-0355
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AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina 29621
Principal Investigator: Abhijit Raval, MD
Phone: 864-512-8519
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VitaLink Research - Anderson
55 East Camperdown Way
Anderson, South Carolina 29621
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Asheville Cardiology Associates
Asheville, North Carolina 28802
Principal Investigator: Benjamin Trichon, MD
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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Micah Fisher
Phone: 404-727-2011
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Augusta University
Augusta, Georgia 30912
Principal Investigator: Clark McDonough, DO
Phone: 706-721-5636
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University of Colorado Denver
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Todd Bull, MD
Phone: 303-724-7466
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Aurora Denver Cardiology Associates
Aurora, Colorado 80012
Principal Investigator: Nampalli Vijay, MD
Phone: 303-839-7789
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Piedmont Physicians Georgia Lung
275 Collier Road Northwest
Austell, Georgia 30309
Principal Investigator: Amy Case, MD
Phone: 770-745-1404
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Bay Area Cardiology Associates, P.A.
Brandon, Florida 33511
Principal Investigator: Robert Dewhurst, MD
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Rahul Argula, MD
Phone: 843-792-8092
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St. Luke's Hospital
Chesterfield, Missouri 63017
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Phone: 314-682-3653
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University of Illinois at Chicago Hospital
Chicago, Illinois 60612
Principal Investigator: Dustin Fraidenburg, MD
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The Lindner Research Center The Christ Hospital Health Network
Cincinnati, Ohio 45219
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MedTrial, LLC
2110 North Beltline Boulevard
Columbia, South Carolina 29204
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The Ohio State University, Wexner Medical Center
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Veronica Franco, MD
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Hamilton Mill Clinical Research
3625 Braselton Highway
Dacula, Georgia 30019
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Henry Ford Health System
Detroit, Michigan 48202
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Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Sudarshan Rajagopal, MD
Phone: 919-668-2642
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Inova Heart and Vascular Institute
Falls Church, Virginia 22042
Principal Investigator: Mitchell Psotka, MD
Phone: 703-776-2018
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Stern Cardiovascular Foundation
Germantown, Tennessee 38138
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Phone: 901-271-4164
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Spectrum Health Medical Group
Grand Rapids, Michigan 69546
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Houston Methodist Research Institute
Houston, Texas 77030
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Saint Vincent Hospital and Health Services
2001 W 86th St
Indianapolis, Indiana 46260
(317) 338-2345
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Indiana University Health - Methodist Research Institute
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Community Heart and Vascular Hospital
Indianapolis, Indiana 46250
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University of Iowa Hospitals and Clinics
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Linda Cadaret, M.D.
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Mayo Clinic, Jacksonville
Jacksonville, Florida 32216
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Phone: 904-953-7625
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St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville, Florida 33204
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University of Kansas Medical Center
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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Saint Luke's Hospital, Kansas City
4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
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Summit Medical Group
Knoxville, Tennessee 37909
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Lancaster General Hospital
555 N Duke St
Lancaster, Pennsylvania 17602
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Dartmouth Hitchcock Medical Center
1 Medical Center Dr
Lebanon, New Hampshire 03756
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Principal Investigator: Bruce Andrus, MD
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South Denver Cardiology
Littleton, Colorado 80120
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VA Healthcare System of Greater Los Angeles
Los Angeles, California 90073
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University of California, Los Angeles - Pulmonary Division
Los Angeles, California 90024
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Kentuckiana Pulmonary Associates
Louisville, Kentucky 40202
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University of Louisville Physicians Outpatient Center
Louisville, Kentucky 40202
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Texas Tech University Health Sciences Center
Lubbock, Texas 79430
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WellStar Medical Group
55 Whitcher Street
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Loyola University Medical Center
2160 South 1st Avenue
Maywood, Illinois 60153
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Advanced Medical Pain Management (AMPM) Research Clinic
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Aurora St. Luke's Medical Center
2900 W Oklahoma Ave
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Medical College of Wisconsin
8701 W Watertown Plank Rd
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Barnabas Health Lung Center
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Sentara Cardiovascular Research Institute
Norfolk, Virginia 23507
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Advocate Christ Medical Center
4440 West 95th Street
Oak Lawn, Illinois 60453
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Florida Hospital
601 E Rollins St
Orlando, Florida 32803
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Pensacola, Florida 32504
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Banner - University Medical Center Phoenix
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Pinehurst Medical Clinic
Pinehurst, North Carolina 28734
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Allegheny General Hospital
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
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Oregon Clinic
Portland, Oregon 97210
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Virginia Commonwealth University
Richmond, Virginia 23298
(804) 828-0100
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Carilion Clinic
Roanoke, Virginia
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University of California, Davis Medical Center
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Roblee Allen, MD
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Santa Barbara Cottage Hospital
Santa Barbara, California 93105
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Chest Medicine Associates
100 Foden Road
South Portland, Maine 04106
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Providence Medical Research Center
Spokane, Washington 99204
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Pulmonary Health Physicians
Syracuse, New York 13210
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University of South Florida, Tampa General Hospital
Tampa, Florida 33606
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University of Toldedo Medical Center
3000 Arlington Avenue
Toledo, Ohio 43614
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University of Arizona
Tucson, Arizona 85721
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MedStar Georgetown University Hospital
Washington, District of Columbia 20007
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Iowa Heart Center, P.C.
West Des Moines, Iowa 50266
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