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
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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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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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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
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Phone: 617-636-1334
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Montefiore Medical Center
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
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Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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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
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Houston, Texas 77030
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University of Kentucky Medical Center
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Univ of Minnesota
Minneapolis, Minnesota 55455
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
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Mount Sinai Hospital
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
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Central Florida Pulmonary Group, PA
326 North Mills Avenue
Orlando, Florida 32803
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Cleveland Clinic Florida
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
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Albany Medical College
47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
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AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina 29621
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Asheville, North Carolina 28802
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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
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Augusta University
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University of Colorado Denver
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Aurora, Colorado 80045
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Aurora Denver Cardiology Associates
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Piedmont Physicians Georgia Lung
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Austell, Georgia 30309
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Bay Area Cardiology Associates, P.A.
Brandon, Florida 33511
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
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St. Luke's Hospital
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MedTrial, LLC
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The Ohio State University, Wexner Medical Center
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Henry Ford Health System
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Duke Univ Med Ctr
2301 Erwin Rd
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Inova Heart and Vascular Institute
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Spectrum Health Medical Group
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University of Iowa Hospitals and Clinics
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Mayo Clinic, Jacksonville
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St. Vincent's Lung, Sleep, and Critical Care Specialists
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University of Kansas Medical Center
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Saint Luke's Hospital, Kansas City
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Summit Medical Group
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Lancaster General Hospital
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Dartmouth Hitchcock Medical Center
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South Denver Cardiology
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VA Healthcare System of Greater Los Angeles
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Kentuckiana Pulmonary Associates
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Richmond, Virginia 23298
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University of California, Davis Medical Center
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Santa Barbara, California 93105
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Chest Medicine Associates
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