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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

STUDY OBJECTIVES Primary objective(s) 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.

Official Title

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

Keywords

Pulmonary Hypertension LVAD Hypertension Hypertension, Pulmonary Macitentan

Eligibility

You can join if…

Open to people ages 18 years and up

  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 (e.g., HeartMate II or HeartWare) within 45 days prior to Randomization.
  4. Hemodynamic evidence of PH on Baseline right heart catheterization (RHC). Baseline RHC is defined as the last hemodynamic measurements after LVAD implantation and prior to Screening. Baseline RHC can be obtained via either routine RHC or pulmonary artery catheter. PH is defined as: Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and Pulmonary artery wedge pressure (PAWP) ≤ 18 mmHg
  5. PVR > 3 Wood units.
  6. Stabilization of the patient after removal of the pulmonary artery catheter, defined as:
  7. No LVAD pump speed/flow rate changes for 48 h prior to Screening and
  8. Stable dose of diuretics for 48 h prior to Screening and
  9. No intravenous (i.v.) inotropes or vasopressors for 48 hours (h) prior to Screening and
  10. Patient able to ambulate 48 h prior to Screening.
  11. A woman of childbearing potential is eligible if she has:
  12. A negative serum pregnancy test at Screening and a negative serum pregnancy test at Baseline.
  13. Agreed to undertake monthly serum pregnancy tests during the study and up to 30 days after study drug discontinuation.
  14. Agreed to use one of the methods of contraception / follow the contraception scheme described in the protocol from Screening up to at least 30 days after study treatment discontinuation.

You CAN'T join if...

  1. Documented severe obstructive lung disease defined as: forced expiratory volume (FEV)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 Screening.
  6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × the upper limit of normal (ULN) at Screening.
  7. Severe hepatic impairment, e.g., Child-Pugh Class C liver disease.
  8. Body weight < 40 kg at Screening.
  9. Doppler mean blood pressure < 65 mmHg at Screening.
  10. . GFR < 30 mL/min at Screening.
  11. . Pregnant, planning to become pregnant during the study period, or breastfeeding.
  12. . Treatment with endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE5)inhibitors, intravenous (i.v)., subcutaneous (s.c.), or oral prostanoids, or guanylate cyclase stimulators within 7 days prior to Baseline RHC, or planned treatment during the study period.
  13. . Treatment with inhaled prostanoids (e.g., iloprost, epoprostenol) or nitric oxide within 24 h prior to Baseline RHC, or planned treatment during the study period.
  14. . Treatment with i.v. inotropes or vasopressors within 24 h prior to Baseline RHC.
  15. . 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).
  16. . 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).
  17. . Treatment with another investigational drug (planned, or taken within the 28 days prior to Baseline RHC).
  18. . Known hypersensitivity to ERAs, or to any of the study treatment excipients.
  19. . Any condition that prevents compliance with the protocol or adherence to therapy.
  20. . Known concomitant life-threatening disease with a life expectancy < 12 months.

Locations

  • #132_University of California San Francisco accepting new patients
    San Francisco, California, 94143, United States
  • #139_Icahn School of Medicine at Mount Sinai accepting new patients
    New York, New York, 94080, United States
  • #110_Sutter Heart Institute accepting new patients
    Sacramento, California, 95819, United States
  • #106_Cedars-Sinai Medical Center accepting new patients
    Beverly Hills, California, 90211, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Actelion
ID
NCT02554903
Phase
Phase 2
Lead Scientist
Munir Janmohamed
Study Type
Interventional
Last Updated
October 2016
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