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 |
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.
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
1305 York Avenue
New York, New York 10021
New York, New York 10021
Principal Investigator: Evelyn Horn, MD
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600 North Wolfe Street
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Principal Investigator: Ryan Tedford, MD
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8700 Beverly Boulevard
Beverly Hills, California 90211
Beverly Hills, California 90211
Principal Investigator: Jaime Moriguchi, MD
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800 Washington Street
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Principal Investigator: Amanda Vest, MD
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Boston, Massachusetts 02114
Principal Investigator: Greg Lewis, MD
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45 Francis Street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Principal Investigator: Michael Givertz, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
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...
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114 University Circle
Charlottesville, Virginia 22905
Charlottesville, Virginia 22905
Principal Investigator: Jamie Kennedy, MD
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Chicago, Illinois 60637
Principal Investigator: Valluvan Jeevanandam, MD
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234 Goodman Street
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
Principal Investigator: Jean Elwing, MD
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9500 Euclid Avenue
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Principal Investigator: Miriam Jacob, MD
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7 Richland Medical Park Drive
Columbia, South Carolina 29203
Columbia, South Carolina 29203
Principal Investigator: Patrick J McCann, MD
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410 West 10th Avenue
Columbus, Ohio 43210
Columbus, Ohio 43210
Principal Investigator: Veronica Franco, MD
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Dallas, Texas 75226
Principal Investigator: Shelley Hall, MD
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Hershey, Pennsylvania 17033
Principal Investigator: David Silber, MD
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1801 Senate Boulevard
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Principal Investigator: Marco Caccamo, DO
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8333 Naab Road
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
Principal Investigator: Ashwin Ravichandran, MD
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200 Hawkins Drive
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Principal Investigator: Vladimir Cotarlan-Nistor, MD
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4401 Wornall Rd
Kansas City, Missouri 64111
Kansas City, Missouri 64111
Principal Investigator: Mark Everley, MD
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La Jolla, California 92037
Principal Investigator: Eric Adler, MD
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600 Highland Avenue
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Principal Investigator: Ravi Dhingra
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Memphis, Tennessee 38120
Principal Investigator: Jawwad Yusuf, MD
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1211 Medical Center Drive
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Principal Investigator: Mary Keebler, MD
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105 Medical Center Drive
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
Principal Investigator: Stacy Mandra, MD
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New York, New York 94080
Principal Investigator: Raymond Bietry, MD
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4440 95th Street
Oak Lawn, Illinois 60453
Oak Lawn, Illinois 60453
Principal Investigator: Antone Tatooles, MD
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3300 Northwest Expressway
Oklahoma City, Oklahoma 73112
Oklahoma City, Oklahoma 73112
Principal Investigator: Doug Horstmanshof, MD
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Omaha, Nebraska 68918
Principal Investigator: Ronald Zolty, MD
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2501 North Orange Avenue
Orlando, Florida 32804
Orlando, Florida 32804
Principal Investigator: Scott Silvestry, MD
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Philadelphia, Pennsylvania 19104
Principal Investigator: Jeremy Mazurek, MD
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5777 E Mayo Blvd
Phoenix, Arizona 85054
Phoenix, Arizona 85054
Principal Investigator: Robert Scott, MD
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320 East North Avenue
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
Principal Investigator: Richard Agarwal, MD
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130 De Soto Street
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Principal Investigator: Jeffery Teuteberg, MD
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Richmond, Virginia 23298
Principal Investigator: Melissa Smallfield, MD
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200 1st Street Southwest
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Principal Investigator: Robert Frantz, MD
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5151 F Street
Sacramento, California 95819
Sacramento, California 95819
Principal Investigator: John Chin, MD
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Principal Investigator: Shane LaRue, MD
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4499 Medical Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
Principal Investigator: Chandra Kunavarapu, VM
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2 Koret Way
San Francisco, California 94143
San Francisco, California 94143
Principal Investigator: Munir Janmohamed, MD
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3000 Arlington Avenue
Toledo, Ohio 43614
Toledo, Ohio 43614
Principal Investigator: Mark Bonnell
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110 Irving Street Northwest
Washington, District of Columbia 20010
Washington, District of Columbia 20010
Principal Investigator: David Majure, MD
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