Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:March 28, 2016
End Date:July 1, 2021
Contact:Mona Selej, MD
Email:mselej@its.jnj.com
Phone:650-624-6900

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

A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation

STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary
vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH)
after left ventricular assist device (LVAD) implantation.

Secondary objectives To evaluate the effect of macitentan 10 mg as compared to placebo on
cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD
implantation.

To evaluate the safety and tolerability of macitentan 10 mg in subjects with PH after LVAD
implantation.

Exploratory objectives To explore the potential effect of macitentan 10 mg as compared to
placebo on right ventricular function in subjects with PH after LVAD implantation.

To explore the potential effect of macitentan 10 mg as compared to placebo on selected
clinical events in subjects with PH after LVAD implantation.

To explore the potential effect of macitentan 10 mg as compared to placebo on renal function
as measured by glomerular filtration rate (GFR) in subjects with PH after LVAD implantation.


Inclusion Criteria:

1. Written Informed Consent prior to initiation of any study-mandated procedure.

2. Males or females ≥ 18 years of age.

3. Surgical implantation of LVAD within 90 days prior to Randomization.

4. Hemodynamic evidence of PH on Baseline right heart catheterization (RHC) by the
thermodilution method. Baseline RHC is defined as the last hemodynamic measurements
after LVAD implantation and prior to the first dose of study treatment. PH is defined
as:

1. Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and

2. Pulmonary artery wedge pressure (PAWP) ≤ 18 mmHg and

3. PVR > 3 Wood units.

5. Stabilization of the patient for 48 h prior to the Baseline RHC, defined as:

1. No LVAD pump speed/flow rate changes and

2. Stable dose of oral diuretics and

3. No intravenous (i.v.) inotropes or vasopressors and

4. Patient able to ambulate.

6. A woman of childbearing potential is eligible only if she has:

1. A negative serum pregnancy test result during the Screening period (Visit 1) and
Randomization (Visit 2) and

2. Agreement to undertake monthly serum pregnancy tests during the study and up to
30 days after study treatment discontinuation and

3. Agreement to use one of the methods of contraception / follow the contraception
scheme described in Section 4.5 from Screening and up to at least 30 days after
study treatment discontinuation.

7. Patient must be randomized within 14 days of Baseline RHC.

Exclusion Criteria:

1. Documented severe obstructive lung disease defined as: forced expiratory volume in 1
second / forced vital capacity (FEV1/FVC) < 0.7 associated with FEV1 < 50% of
predicted value after bronchodilator administration.

2. Documented moderate to severe restrictive lung disease defined as: total lung capacity
< 60% of predicted value.

3. Documented pulmonary veno-occlusive disease.

4. Patients undergoing dialysis.

5. Hemoglobin < 8.5 g/dL at Randomization.

6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × the upper
limit of normal (ULN) at Randomization.

7. Severe hepatic impairment, e.g., Child-Pugh Class C liver disease.

8. Body weight < 40 kg at Randomization.

9. Doppler mean blood pressure < 65 mmHg at Randomization.

10. GFR < 30 mL/min at Randomization.

11. Pregnant, planning to become pregnant during the study period, or breastfeeding.

12. Treatment with endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE5)
inhibitors, i.v., subcutaneous (s.c.), or oral prostanoids, or guanylate cyclase
stimulators within 7 days prior to Baseline RHC or study treatment initiation.

13. Treatment with inhaled prostanoids (e.g., iloprost, epoprostenol) or nitric oxide
within 24 h prior to Baseline RHC or study treatment initiation.

14. Treatment with strong inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 28 days
prior to study treatment initiation (e.g., carbamazepine, rifampicin, rifabutin,
phenytoin and St. John's Wort).

15. Treatment with strong inhibitors of CYP3A4 within 28 days prior to study treatment
initiation (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin,
telithromycin, nefazodone, ritonavir, saquinavir, boceprevir, telaprevir, iopinavir,
fosamprenavir, darunavir, tipranavir, atazanavir, nelfinavir, amprenavir, and
idinavir).

16. Treatment with another investigational drug (planned, or taken) within 28 days prior
to study treatment initiation.

17. Known hypersensitivity to ERAs, or to any of the study treatment excipients.

18. Any condition that prevents compliance with the protocol or adherence to therapy.

19. Known concomitant life-threatening disease with a life expectancy < 12 months.
We found this trial at
51
sites
Dallas, Texas 75226
Principal Investigator: Shelley Hall, MD
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Austin, Texas 78705
Principal Investigator: Ernest Haeusslein, MD
?
mi
from
Austin, TX
Click here to add this to my saved trials
600 North Wolfe Street
Baltimore, Maryland 21287
Principal Investigator: Ryan Tedford, MD
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
8700 Beverly Boulevard
Beverly Hills, California 90211
Principal Investigator: Jaime Moriguchi, MD
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
800 Washington Street
Boston, Massachusetts 02111
Principal Investigator: Amanda Vest, MD
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02114
Principal Investigator: Greg Lewis, MD
?
mi
from
Boston, MA
Click here to add this to my saved trials
45 Francis Street
Boston, Massachusetts 02115
Principal Investigator: Michael Givertz, MD
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bronx, New York 10467
Principal Investigator: Ulrich Jorde, MD
?
mi
from
Bronx, NY
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Brian Houston
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
114 University Circle
Charlottesville, Virginia 22905
Principal Investigator: Jamie Kennedy, MD
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chicago, Illinois 60637
Principal Investigator: Valluvan Jeevanandam, MD
?
mi
from
Chicago, IL
Click here to add this to my saved trials
234 Goodman Street
Cincinnati, Ohio 45242
Principal Investigator: Jean Elwing, MD
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44195
Principal Investigator: Miriam Jacob, MD
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
7 Richland Medical Park Drive
Columbia, South Carolina 29203
Principal Investigator: Patrick J McCann, MD
?
mi
from
Columbia, SC
Click here to add this to my saved trials
410 West 10th Avenue
Columbus, Ohio 43210
Principal Investigator: Veronica Franco, MD
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Falls Church, Virginia 22042
Principal Investigator: Shashank Desai, MD
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
Principal Investigator: David Silber, MD
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Myung Park, MD
?
mi
from
Houston, TX
Click here to add this to my saved trials
1801 Senate Boulevard
Indianapolis, Indiana 46202
Principal Investigator: Marco Caccamo, DO
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
8333 Naab Road
Indianapolis, Indiana 46260
Principal Investigator: Ashwin Ravichandran, MD
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
200 Hawkins Drive
Iowa City, Iowa 52242
Principal Investigator: Vladimir Cotarlan-Nistor, MD
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
4401 Wornall Rd
Kansas City, Missouri 64111
Principal Investigator: Mark Everley, MD
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
La Jolla, California 92037
Principal Investigator: Eric Adler, MD
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lexington, Kentucky 40536
Principal Investigator: Maya Guglin, MD
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Louisville, Kentucky 40202
Principal Investigator: Emma Birks, MD
?
mi
from
Louisville, KY
Click here to add this to my saved trials
600 Highland Avenue
Madison, Wisconsin 53792
Principal Investigator: Ravi Dhingra
?
mi
from
Madison, WI
Click here to add this to my saved trials
Memphis, Tennessee 38120
Principal Investigator: Jawwad Yusuf, MD
?
mi
from
Memphis, TN
Click here to add this to my saved trials
1211 Medical Center Drive
Nashville, Tennessee 37232
Principal Investigator: Mary Keebler, MD
?
mi
from
Nashville, TN
Click here to add this to my saved trials
105 Medical Center Drive
New Orleans, Louisiana 70121
Principal Investigator: Stacy Mandra, MD
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
1305 York Avenue
New York, New York 10021
Principal Investigator: Evelyn Horn, MD
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 94080
Principal Investigator: Raymond Bietry, MD
?
mi
from
New York, NY
Click here to add this to my saved trials
4440 95th Street
Oak Lawn, Illinois 60453
Principal Investigator: Antone Tatooles, MD
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
3300 Northwest Expressway
Oklahoma City, Oklahoma 73112
Principal Investigator: Doug Horstmanshof, MD
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68918
Principal Investigator: Ronald Zolty, MD
?
mi
from
Omaha, NE
Click here to add this to my saved trials
2501 North Orange Avenue
Orlando, Florida 32804
Principal Investigator: Scott Silvestry, MD
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
Principal Investigator: Jeremy Mazurek, MD
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
5777 E Mayo Blvd
Phoenix, Arizona 85054
Principal Investigator: Robert Scott, MD
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
320 East North Avenue
Pittsburgh, Pennsylvania 15212
Principal Investigator: Richard Agarwal, MD
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
130 De Soto Street
Pittsburgh, Pennsylvania 15213
Principal Investigator: Jeffery Teuteberg, MD
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Richmond, Virginia 23298
Principal Investigator: Melissa Smallfield, MD
?
mi
from
Richmond, VA
Click here to add this to my saved trials
200 1st Street Southwest
Rochester, Minnesota 55905
Principal Investigator: Robert Frantz, MD
?
mi
from
Rochester, MN
Click here to add this to my saved trials
5151 F Street
Sacramento, California 95819
Principal Investigator: John Chin, MD
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
660 South Euclid Avenue
Saint Louis, Missouri 63110
Principal Investigator: Shane LaRue, MD
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84112
Principal Investigator: Edward Gilbert, MD
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
4499 Medical Drive
San Antonio, Texas 78229
Principal Investigator: Chandra Kunavarapu, VM
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
2 Koret Way
San Francisco, California 94143
Principal Investigator: Munir Janmohamed, MD
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
3000 Arlington Avenue
Toledo, Ohio 43614
Principal Investigator: Mark Bonnell
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Tucson, Arizona 85724
Principal Investigator: Jennifer Cook, MD
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Valhalla, New York 10595
Principal Investigator: Gregg Lanier, MD
?
mi
from
Valhalla, NY
Click here to add this to my saved trials
110 Irving Street Northwest
Washington, District of Columbia 20010
Principal Investigator: David Majure, MD
?
mi
from
Washington,
Click here to add this to my saved trials