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 |
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.
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
Jacksonville, Florida 32216
Principal Investigator: Charles Burger, MD
Phone: 904-953-7625
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
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...
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
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...
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
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...
Click here to add this to my saved trials
3550 Jerome Avenue
Bronx, New York 10467
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...
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
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...
Click here to add this to my saved trials
3500 Gaston Avenue
Dallas, Texas 75246
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...
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
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...
Click here to add this to my saved trials
740 South Limestone Street
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Principal Investigator: David Booth, MD
Phone: 859-218-2880
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
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...
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...
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
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...
Click here to add this to my saved trials
1 Gustave L Levy Pl # 271
New York, New York 10029
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...
Click here to add this to my saved trials
326 North Mills Avenue
Orlando, Florida 32803
Orlando, Florida 32803
Principal Investigator: Hadi Chohan, MD
Phone: 407-841-1100
Click here to add this to my saved trials
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
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...
Click here to add this to my saved trials
47 New Scotland Ave
Albany, New York 12208
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...
Click here to add this to my saved trials
Anderson, South Carolina 29621
Principal Investigator: Abhijit Raval, MD
Phone: 864-512-8733
Click here to add this to my saved trials
55 East Camperdown Way
Anderson, South Carolina 29621
Anderson, South Carolina 29621
Principal Investigator: Charles Thompson, MD
Phone: 864-965-0195
Click here to add this to my saved trials
Asheville, North Carolina 28802
Principal Investigator: Benjamin Trichon, MD
Phone: 828-274-6000
Click here to add this to my saved trials
1364 Clifton Rd NE
Atlanta, Georgia 30322
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...
Click here to add this to my saved trials
Augusta, Georgia 30912
Principal Investigator: Clark McDonough, DO
Phone: 706-721-5636
Click here to add this to my saved trials
13001 E. 17th Pl
Aurora, Colorado 80045
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...
Click here to add this to my saved trials
Aurora, Colorado 80012
Principal Investigator: Nampalli Vijay, MD
Phone: 303-839-7789
Click here to add this to my saved trials
275 Collier Road Northwest
Austell, Georgia 30309
Austell, Georgia 30309
Principal Investigator: Amy Case, MD
Phone: 770-745-1404
Click here to add this to my saved trials
Brandon, Florida 33511
Principal Investigator: Robert Dewhurst, MD
Phone: 813-684-6000
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
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...
Click here to add this to my saved trials
Chesterfield, Missouri 63017
Principal Investigator: Neil Ettinger, MD
Phone: 314-682-3653
Click here to add this to my saved trials
Chicago, Illinois 60612
Principal Investigator: Dustin Fraidenburg, MD
Phone: 312-355-5895
Click here to add this to my saved trials
Cincinnati, Ohio 45219
Principal Investigator: Peter Engel, MD
Phone: 513-585-1777
Click here to add this to my saved trials
2110 North Beltline Boulevard
Columbia, South Carolina 29204
Columbia, South Carolina 29204
Principal Investigator: Carlton (Greg) Cauthen, MD
Phone: 803-254-4295
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
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...
Click here to add this to my saved trials
3625 Braselton Highway
Dacula, Georgia 30019
Dacula, Georgia 30019
Principal Investigator: Rachel Nisbet, MD
Phone: 470-297-6789
Click here to add this to my saved trials
Detroit, Michigan 48202
Principal Investigator: Rana Awdish, M.D.
Phone: 313-916-1254
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
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...
Click here to add this to my saved trials
Falls Church, Virginia 22042
Principal Investigator: Mitchel Psotka, MD
Phone: 703-776-2018
Click here to add this to my saved trials
Germantown, Tennessee 38138
Principal Investigator: Frank McGrew, MD
Phone: 901-271-4164
Click here to add this to my saved trials
Grand Rapids, Michigan 69546
Principal Investigator: Renzo Loyaga-Rendon
Phone: 616-391-5067
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Zeenat Safdar, MD
Phone: 713-363-7536
Click here to add this to my saved trials
2001 W 86th St
Indianapolis, Indiana 46260
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...
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Michael Duncan, MD
Phone: 317-962-9978
Click here to add this to my saved trials
Indianapolis, Indiana 46250
Principal Investigator: Muhamad Safiia, MD
Phone: 317-621-8627
Click here to add this to my saved trials
200 Hawkins Dr,
Iowa City, Iowa 52242
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...
Click here to add this to my saved trials
Jacksonville, Florida 33204
Principal Investigator: Abubakr Bajwa, MD
Phone: 904-450-8255
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
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...
Click here to add this to my saved trials
4401 Wornall Rd
Kansas City, Missouri 64111
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...
Click here to add this to my saved trials
Knoxville, Tennessee 37909
Principal Investigator: John Swisher, MD
Phone: 865-934-2676
Click here to add this to my saved trials
555 N Duke St
Lancaster, Pennsylvania 17602
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...
Click here to add this to my saved trials
1 Medical Center Dr
Lebanon, New Hampshire 03756
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...
Click here to add this to my saved trials
Littleton, Colorado 80120
Principal Investigator: Ira Dauber, MD
Phone: 303-703-2124
Click here to add this to my saved trials
Los Angeles, California 90073
Principal Investigator: Alberta Warner, MD
Phone: 323-479-4328
Click here to add this to my saved trials
Los Angeles, California 90024
Principal Investigator: Rajan Saggar, MD
Phone: 310-794-3299
Click here to add this to my saved trials
Louisville, Kentucky 40202
Principal Investigator: John McConnell, M.D.
Phone: 502-587-8000
Click here to add this to my saved trials
Louisville, Kentucky 40202
Principal Investigator: El-Kersh Karim, MD
Phone: 502-852-8739
Click here to add this to my saved trials
Lubbock, Texas 79430
Principal Investigator: Alejandro Marmol-Velez
Phone: 915-215-4190
Click here to add this to my saved trials
55 Whitcher Street
Marietta, Georgia 30060
Marietta, Georgia 30060
Principal Investigator: Dhaval Patel, MD
Phone: 470-793-4046
Click here to add this to my saved trials
2160 South 1st Avenue
Maywood, Illinois 60153
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...
Click here to add this to my saved trials
17760 Northwest 2nd Avenue
Miami Gardens, Florida 33169
Miami Gardens, Florida 33169
Principal Investigator: Javier Jimenez
Phone: 305-999-3301
Click here to add this to my saved trials
2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
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...
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
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...
Click here to add this to my saved trials
1700 SpringHill Avenue
Mobile, Alabama 36604
Mobile, Alabama 36604
Principal Investigator: Adrian Divittorio, MD
Phone: 251-435-1651
Click here to add this to my saved trials
Morgantown, West Virginia
Principal Investigator: George Sokos, MD
Phone: 304-598-6424
Click here to add this to my saved trials
201 Lyons Avenue
Newark, New Jersey 07112
Newark, New Jersey 07112
Principal Investigator: Christina Migliore, MD
Phone: 973-926-8578
Click here to add this to my saved trials
Norfolk, Virginia 23507
Principal Investigator: Michael Eggert, MD
Phone: 757-388-4024
Click here to add this to my saved trials
4440 West 95th Street
Oak Lawn, Illinois 60453
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
Click here to add this to my saved trials
601 E Rollins St
Orlando, Florida 32803
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
Click here to add this to my saved trials
Pensacola, Florida 32504
Principal Investigator: Rohit Amin, MD
Phone: 850-477-7900
Click here to add this to my saved trials
Phoenix, Arizona 85006
Principal Investigator: Radha Gopalan, MD
Phone: 602-828-2431
Click here to add this to my saved trials
Pinehurst, North Carolina 28734
Principal Investigator: Michael Pritchett, MD
Phone: 910-235-3144
Click here to add this to my saved trials
320 E North Ave
Pittsburgh, Pennsylvania 15212
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...
Click here to add this to my saved trials
Portland, Oregon 97210
Principal Investigator: Hataya (Kristy) Poonyagariyagorn, MD
Phone: 503-297-3778
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
2315 Stockton Blvd.
Sacramento, California 95817
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...
Click here to add this to my saved trials
Santa Barbara, California 93105
Principal Investigator: Jeffrey Sager, MD
Phone: 805-569-7461
Click here to add this to my saved trials
100 Foden Road
South Portland, Maine 04106
South Portland, Maine 04106
Principal Investigator: Joel Wirth
Phone: 207-828-1122
Click here to add this to my saved trials
Spokane, Washington 99204
Principal Investigator: Bryan Fuhs, MD
Phone: 509-474-2041
Click here to add this to my saved trials
Syracuse, New York 13210
Principal Investigator: Sherif El Bayadi, MD
Phone: 315-234-0816
Click here to add this to my saved trials
Tampa, Florida 33606
Principal Investigator: Ricardo Restrepo-Jaramillo, MD
Phone: 813-844-4306
Click here to add this to my saved trials
Toledo, Ohio 43614
Principal Investigator: Samer Khouri, MD
Phone: 419-383-3853
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...
Click here to add this to my saved trials
Washington, District of Columbia 20007
Principal Investigator: Tunay Kuru, MD
Phone: 202-444-1224
Click here to add this to my saved trials
West Des Moines, Iowa 50266
Principal Investigator: Randy Rough, MD
Phone: 515-633-3845
Click here to add this to my saved trials