Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:3/9/2019
Start Date:August 15, 2017
End Date:July 2020
Contact:David B Yehle, RPh
Email:dyehle@unither.com
Phone:919 485-8350

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) in Heart Failure With Preserved Ejection Fraction (HFpEF)

This is a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind,
placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary
hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).
Once randomized, subjects will take the initial dose of study drug at the study site on the
day of randomization. Subjects will return to the study site for visits scheduled at Weeks 6,
12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.


Inclusion Criteria:

1. A subject can qualify if they have undergone a right heart catheterization (RHC)
within 180 days of Baseline.

2. The subject has a diagnosis of heart failure with a left ventricular ejection fraction
(LVEF) ≥45% by echocardiogram (ECHO) completed during Screening (prior to
randomization).

3. The subject's baseline 6MWD must be at least 150 meters.

4. The subject has pulmonary function tests conducted within 6 months of Screening or
during the Screening phase.

5. Subjects on a chronic medication for heart failure must be on a stable dose for ≥30
days prior to randomization.

6. Subjects on chronic medications for any underlying respiratory condition must be on a
stable dose for ≥30 days prior to randomization.

Exclusion Criteria:

1. The subject is pregnant or lactating.

2. In the opinion of the Principal Investigator, the subject has a primary diagnosis of
PH other than WHO Group 2 PH.

3. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or
prostacyclin analogue that resulted in discontinuation of therapy or inability to
effectively titrate that therapy.

4. The subject has received any approved PAH therapies within 30 days of randomization.
Chronic use of an approved phosphodiesterase type 5 inhibitor (PDE5-I) is allowed as
long as the subject has been on a stable dose for at least 90 days prior to
randomization and has had an RHC confirming the parameters necessary for inclusion in
the study after being on a stable PDE5-I dose for at least 30 days.

5. The subject has been hospitalized for a cardiopulmonary indication within 30 days of
randomization.

6. The subject had a myocardial infarction within 90 days of randomization.

7. The subject had cardiac resynchronization therapy within 90 days of randomization or
anticipated resynchronization therapy during the study treatment period.

8. The subject has liver function tests greater than 3 times the upper limit of normal at
Screening, clinically significant liver disease/dysfunction, known Child-Pugh Class C
hepatic disease, or noncirrhotic portal hypertension.

9. The subject has uncontrolled systemic hypertension, systolic blood pressure <100 mmHg,
or a resting heart rate >100 beats per minute at Baseline.

10. The subject has known genetic hypertrophic cardiomyopathy, sarcoidosis, or cardiac
amyloidosis.

11. The subject has a known history of any LVEF less than 40% by ECHO within 3 years of
randomization. Note: a transient decline in LVEF below 40% that occurred and recovered
more than 6 months before the start of Screening and was associated with an acute
intercurrent condition (eg, atrial fibrillation) is allowed.

12. The subject has hemodynamically significant valvular heart disease as determined by
the Investigator, including: greater than mild aortic and/or mitral stenosis or severe
mitral and/or aortic regurgitation (>Grade 3)

13. The subject has a Body Mass Index >45 kg/m^2.

14. The subject has any musculoskeletal disorder, or has any other condition that limits
ambulation.

15. The subject has end-stage renal disease requiring/receiving dialysis.

16. The subject participated in an investigational drug or device study within 30 days
prior to signing consent.
We found this trial at
82
sites
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
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
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
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
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
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
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
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
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
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
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
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Evan Brittain, MD
Phone: 615-322-8067
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
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
326 North Mills Avenue
Orlando, Florida 32803
Principal Investigator: Hadi Chohan, MD
Phone: 407-841-1100
?
mi
from
Orlando, FL
Click here to add this to my saved trials
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
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
Anderson, South Carolina 29621
Principal Investigator: Abhijit Raval, MD
Phone: 864-512-8733
?
mi
from
Anderson, SC
Click here to add this to my saved trials
55 East Camperdown Way
Anderson, South Carolina 29621
Principal Investigator: Charles Thompson, MD
Phone: 864-965-0195
?
mi
from
Anderson, SC
Click here to add this to my saved trials
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
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, Georgia 30912
Principal Investigator: Clark McDonough, DO
Phone: 706-721-5636
?
mi
from
Augusta, GA
Click here to add this to my saved trials
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, Colorado 80012
Principal Investigator: Nampalli Vijay, MD
Phone: 303-839-7789
?
mi
from
Aurora, CO
Click here to add this to my saved trials
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
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
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
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
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
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
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
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
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
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
Falls Church, Virginia 22042
Principal Investigator: Mitchel Psotka, MD
Phone: 703-776-2018
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
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
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, Texas 77030
Principal Investigator: Zeenat Safdar, MD
Phone: 713-363-7536
?
mi
from
Houston, TX
Click here to add this to my saved trials
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
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
Indianapolis, Indiana 46250
Principal Investigator: Muhamad Safiia, MD
Phone: 317-621-8627
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
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
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
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
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
4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Principal Investigator: Mark Yagan, MD
Phone: 816-932-6056
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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, Florida 32504
Principal Investigator: Rohit Amin, MD
Phone: 850-477-7900
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
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, 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
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
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
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
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
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, 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
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
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
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
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
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
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
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
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