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

Use our guide to learn which trials are right for you!

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
Virginia Commonwealth University
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Melissa Smallfield, MD
Phone: 804-828-7966
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Indranee Rajapreyar, MD
Phone: 205-975-9426
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Brigham and Women's Hosp
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Aaron Waxman, MD
Phone: 617-525-9731
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Montefiore Medical Center
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Sandhya Murthy, MD
Phone: 718-920-8780
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
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...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Baylor University Medical Center
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Yolanda Mageto, MD
Phone: 214-820-5829
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
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
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
University of Kentucky Medical Center
740 South Limestone Street
Lexington, Kentucky 40536
Principal Investigator: David Booth, MD
Phone: 859-218-2880
?
mi
from
Lexington, KY
Click here to add this to my saved trials
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
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Univ of Minnesota
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Thenappan Thenappan, MD
Phone: 612-626-6237
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Ivan Robbins, MD
Phone: 615-322-3412
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
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
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
Click here to add this to my saved trials
Central Florida Pulmonary Group, PA
326 North Mills Avenue
Orlando, Florida 32803
Principal Investigator: Hadi Chohan, MD
Phone: 407-426-9299
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Cleveland Clinic Florida
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Principal Investigator: Jinesh Mehta, MD
Phone: 954-659-6213
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
?
mi
from
Weston, FL
Click here to add this to my saved trials
Albany Medical College
47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: Boris Medarov, MD
Phone: 518-262-0355
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
?
mi
from
Albany, NY
Click here to add this to my saved trials
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina 29621
Principal Investigator: Abhijit Raval, MD
Phone: 864-512-8519
?
mi
from
Anderson, SC
Click here to add this to my saved trials
VitaLink Research - Anderson
55 East Camperdown Way
Anderson, South Carolina 29621
Principal Investigator: Charles Thompson, MD
Phone: 864-965-0190
?
mi
from
Anderson, SC
Click here to add this to my saved trials
Asheville Cardiology Associates
Asheville, North Carolina 28802
Principal Investigator: Benjamin Trichon, MD
Phone: 828-274-6000
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Micah Fisher
Phone: 404-727-2011
Emory University Hospital As the largest health care system in Georgia and the only health...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Augusta University
Augusta, Georgia 30912
Principal Investigator: Clark McDonough, DO
Phone: 706-721-5636
?
mi
from
Augusta, GA
Click here to add this to my saved trials
University of Colorado Denver
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Todd Bull, MD
Phone: 303-724-7466
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Aurora Denver Cardiology Associates
Aurora, Colorado 80012
Principal Investigator: Nampalli Vijay, MD
Phone: 303-839-7789
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Piedmont Physicians Georgia Lung
275 Collier Road Northwest
Austell, Georgia 30309
Principal Investigator: Amy Case, MD
Phone: 770-745-1404
?
mi
from
Austell, GA
Click here to add this to my saved trials
Bay Area Cardiology Associates, P.A.
Brandon, Florida 33511
Principal Investigator: Robert Dewhurst, MD
Phone: 813-684-6000
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Rahul Argula, MD
Phone: 843-792-8092
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
St. Luke's Hospital
Chesterfield, Missouri 63017
Principal Investigator: Neil Ettinger, MD
Phone: 314-682-3653
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
University of Illinois at Chicago Hospital
Chicago, Illinois 60612
Principal Investigator: Dustin Fraidenburg, MD
Phone: 312-355-5895
?
mi
from
Chicago, IL
Click here to add this to my saved trials
The Lindner Research Center The Christ Hospital Health Network
Cincinnati, Ohio 45219
Principal Investigator: Peter Engel, MD
Phone: 513-585-1777
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
MedTrial, LLC
2110 North Beltline Boulevard
Columbia, South Carolina 29204
Principal Investigator: Carlton (Greg) Cauthen, MD
Phone: 803-254-4295
?
mi
from
Columbia, SC
Click here to add this to my saved trials
The Ohio State University, Wexner Medical Center
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Veronica Franco, MD
Phone: 614-292-4084
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Hamilton Mill Clinical Research
3625 Braselton Highway
Dacula, Georgia 30019
Principal Investigator: Rachel Nisbet, MD
Phone: 470-297-6789
?
mi
from
Dacula, GA
Click here to add this to my saved trials
Henry Ford Health System
Detroit, Michigan 48202
Principal Investigator: Rana Awdish, M.D.
Phone: 313-916-1254
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Sudarshan Rajagopal, MD
Phone: 919-668-2642
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Inova Heart and Vascular Institute
Falls Church, Virginia 22042
Principal Investigator: Mitchell Psotka, MD
Phone: 703-776-2018
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Stern Cardiovascular Foundation
Germantown, Tennessee 38138
Principal Investigator: Frank McGrew, MD
Phone: 901-271-4164
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Spectrum Health Medical Group
Grand Rapids, Michigan 69546
Principal Investigator: Renzo Loyaga-Rendon
Phone: 616-391-5067
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Houston Methodist Research Institute
Houston, Texas 77030
Principal Investigator: Zeenat Safdar, MD
Phone: 713-363-7536
?
mi
from
Houston, TX
Click here to add this to my saved trials
Saint Vincent Hospital and Health Services
2001 W 86th St
Indianapolis, Indiana 46260
(317) 338-2345
Principal Investigator: Ashwin Ravichandran, MD
Phone: 317-338-6252
Saint Vincent Hospital and Health Services At St.Vincent Indianapolis, everything we do begins with a...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indiana University Health - Methodist Research Institute
Indianapolis, Indiana 46202
Principal Investigator: Michael Duncan, MD
Phone: 317-962-9978
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Community Heart and Vascular Hospital
Indianapolis, Indiana 46250
Principal Investigator: Muhamad Safiia, MD
Phone: 317-621-8629
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
University of Iowa Hospitals and Clinics
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Linda Cadaret, M.D.
Phone: 319-353-5245
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Mayo Clinic, Jacksonville
Jacksonville, Florida 32216
Principal Investigator: Charles Burger, MD
Phone: 904-953-7625
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville, Florida 33204
Principal Investigator: Abubakr Bajwa, MD
Phone: 904-450-8255
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
University of Kansas Medical Center
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Lewis Satterwhite
Phone: 913-588-4022
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Saint Luke's Hospital, Kansas City
4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Principal Investigator: Mark Yagan, MD
Phone: 816-932-5987
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Summit Medical Group
Knoxville, Tennessee 37909
Principal Investigator: John Swisher, MD
Phone: 865-934-2676
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lancaster General Hospital
555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Principal Investigator: Justin Roberts, MD
Phone: 717-544-1777
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Dartmouth Hitchcock Medical Center
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Bruce Andrus, MD
Phone: 603-650-7803
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
South Denver Cardiology
Littleton, Colorado 80120
Principal Investigator: Ira Dauber, MD
Phone: 303-703-2124
?
mi
from
Littleton, CO
Click here to add this to my saved trials
VA Healthcare System of Greater Los Angeles
Los Angeles, California 90073
Principal Investigator: Alberta Warner, MD
Phone: 323-479-4328
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
University of California, Los Angeles - Pulmonary Division
Los Angeles, California 90024
Principal Investigator: Rajan Saggar, MD
Phone: 310-794-3299
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Kentuckiana Pulmonary Associates
Louisville, Kentucky 40202
Principal Investigator: John McConnell, M.D.
Phone: 502-587-8000
?
mi
from
Louisville, KY
Click here to add this to my saved trials
University of Louisville Physicians Outpatient Center
Louisville, Kentucky 40202
Principal Investigator: El-Kersh Karim, MD
Phone: 502-852-8739
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Texas Tech University Health Sciences Center
Lubbock, Texas 79430
Principal Investigator: Alejandro Marmol-Velez
Phone: 915-215-4190
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
WellStar Medical Group
55 Whitcher Street
Marietta, Georgia 30060
Principal Investigator: Dhaval Patel, MD
Phone: 470-793-4046
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Loyola University Medical Center
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: James Gagermeier, MD
Phone: 708-216-5744
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
?
mi
from
Maywood, IL
Click here to add this to my saved trials
Advanced Medical Pain Management (AMPM) Research Clinic
17760 Northwest 2nd Avenue
Miami Gardens, Florida 33169
Principal Investigator: Javier Jimenez
Phone: 305-999-3301
?
mi
from
Miami Gardens, FL
Click here to add this to my saved trials
Aurora St. Luke's Medical Center
2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Principal Investigator: Dianne Zwicke, MD
Phone: 414-649-5664
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Medical College of Wisconsin
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: David Ishizawar, MD
Phone: 414-955-7036
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Diagnostic & Medical Clinic
1700 SpringHill Avenue
Mobile, Alabama 36604
Principal Investigator: Adrian Divittorio, MD
Phone: 251-435-1651
?
mi
from
Mobile, AL
Click here to add this to my saved trials
West Virginia University Hospital
Morgantown, West Virginia
Principal Investigator: George Sokos, MD
Phone: 304-598-6424
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
Barnabas Health Lung Center
201 Lyons Avenue
Newark, New Jersey 07112
Principal Investigator: Christina Migliore, MD
Phone: 973-926-8578
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Sentara Cardiovascular Research Institute
Norfolk, Virginia 23507
Principal Investigator: Michael Eggert, MD
Phone: 757-388-4024
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Advocate Christ Medical Center
4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Principal Investigator: Muhyaldeen Dia, MD
Phone: 708-684-4690
Advocate Christ Medical Center Advocate Health Care, named among the nation
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
Florida Hospital
601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: James Tarver III, MD
Phone: 407-303-9984
Florida Hospital Florida Hospital is one of the country
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Pensacola Research Consultants, Inc.
Pensacola, Florida 32504
Principal Investigator: Rohit Amin, MD
Phone: 850-477-7900
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Banner - University Medical Center Phoenix
Phoenix, Arizona 85006
Principal Investigator: Radha Gopalan, MD
Phone: 602-828-2431
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pinehurst Medical Clinic
Pinehurst, North Carolina 28734
Principal Investigator: Michael Pritchett, MD
Phone: 910-235-3144
?
mi
from
Pinehurst, NC
Click here to add this to my saved trials
Allegheny General Hospital
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Raymond Benza, MD
Phone: 412-359-3293
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Oregon Clinic
Portland, Oregon 97210
Principal Investigator: Hataya (Kristy) Poonyagariyagorn, MD
Phone: 503-297-3778
?
mi
from
Portland, OR
Click here to add this to my saved trials
Carilion Clinic
Roanoke, Virginia
Principal Investigator: Sameh (Sam) Aziz, MD
Phone: 540-224-4661
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
University of California, Davis Medical Center
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Roblee Allen, MD
Phone: 916-734-1554
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Santa Barbara Cottage Hospital
Santa Barbara, California 93105
Principal Investigator: Jeffrey Sager, MD
Phone: 805-569-7461
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
Chest Medicine Associates
100 Foden Road
South Portland, Maine 04106
Principal Investigator: Joel Wirth
Phone: 207-828-1122
?
mi
from
South Portland, ME
Click here to add this to my saved trials
Providence Medical Research Center
Spokane, Washington 99204
Principal Investigator: Bryan Fuhs, MD
Phone: 509-474-2041
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Pulmonary Health Physicians
Syracuse, New York 13210
Principal Investigator: Sherif El Bayadi, MD
Phone: 315-234-0816
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
University of South Florida, Tampa General Hospital
Tampa, Florida 33606
Principal Investigator: Ricardo Restrepo-Jaramillo, MD
Phone: 813-844-4306
?
mi
from
Tampa, FL
Click here to add this to my saved trials
University of Toldedo Medical Center
3000 Arlington Avenue
Toledo, Ohio 43614
Principal Investigator: Samer Khouri, MD
Phone: 419-383-3853
?
mi
from
Toledo, OH
Click here to add this to my saved trials
University of Arizona
Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Franz Rischard, MD
Phone: 520-626-8305
University of Arizona The University of Arizona is a premier, public research university. Established in...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Principal Investigator: Tunay Kuru, MD
Phone: 202-444-1224
?
mi
from
Washington,
Click here to add this to my saved trials
Iowa Heart Center, P.C.
West Des Moines, Iowa 50266
Principal Investigator: Randy Rough, MD
Phone: 515-633-3845
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials