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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Hypertension

In brief

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.

Key facts

Study ID: NCT02554903
Run by: Actelion
People needed: 57
Starts: 2016-03-28
Expected to finish: 2020-03-13
Last updated by the study team: 2025-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Written Informed Consent prior to initiation of any study-mandated procedure.
Males or females ≥ 18 years of age.
Surgical implantation of LVAD within 90 days prior to Randomization.
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:
Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
Pulmonary artery wedge pressure (PAWP) ≤ 18 mmHg and
PVR > 3 Wood units.
Stabilization of the patient for 48 h prior to the Baseline RHC, defined as:
No LVAD pump speed/flow rate changes and
Stable dose of oral diuretics and
No intravenous (i.v.) inotropes or vasopressors and
Patient able to ambulate.
A woman of childbearing potential is eligible only if she has:
A negative serum pregnancy test result during the Screening period (Visit 1) and Randomization (Visit 2) and
Agreement to undertake monthly serum pregnancy tests during the study and up to 30 days after study treatment discontinuation and
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.
Patient must be randomized within 14 days of Baseline RHC.

You may not qualify if…

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.
Documented moderate to severe restrictive lung disease defined as: total lung capacity < 60% of predicted value.
Documented pulmonary veno-occlusive disease.
Patients undergoing dialysis.
Hemoglobin < 8.5 g/dL at Randomization.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × the upper limit of normal (ULN) at Randomization.
Severe hepatic impairment, e.g., Child-Pugh Class C liver disease.
Body weight < 40 kg at Randomization.
Doppler mean blood pressure < 65 mmHg at Randomization.
GFR < 30 mL/min at Randomization.
Pregnant, planning to become pregnant during the study period, or breastfeeding.
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.
Treatment with inhaled prostanoids (e.g., iloprost, epoprostenol) or nitric oxide within 24 h prior to Baseline RHC or study treatment initiation.
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).
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).
Treatment with another investigational drug (planned, or taken) within 28 days prior to study treatment initiation.
Known hypersensitivity to ERAs, or to any of the study treatment excipients.
Any condition that prevents compliance with the protocol or adherence to therapy.
Known concomitant life-threatening disease with a life expectancy < 12 months.

Where it is running

#125_Mayo Clinic Arizona — Phoenix, Arizona, United States
#144_University of Arizona — Tucson, Arizona, United States
#106_Cedars-Sinai Medical Center — Beverly Hills, California, United States
#154_University of California San Diego — La Jolla, California, United States
#110_Sutter Heart Institute — Sacramento, California, United States
#132_University of California San Francisco — San Francisco, California, United States
#123_MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
#126_Florida Hospital — Orlando, Florida, United States
#135_University of Chicago Medical Center — Chicago, Illinois, United States
#113_Advocate Christ Medical Center — Oak Lawn, Illinois, United States
#108_Indiana University Health Physicians Cardiology — Indianapolis, Indiana, United States
#112_St. Vincent Medical Group, Inc — Indianapolis, Indiana, United States
#120_University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
#117_University of Louisville — Louisville, Kentucky, United States
#105_Ochsner Medical Center — New Orleans, Louisiana, United States
#129_John Hopkins University Medical Center — Baltimore, Maryland, United States
#143_Tufts Medical Center — Boston, Massachusetts, United States
#138_Massachusetts General Hospital — Boston, Massachusetts, United States
#119_Brigham and Women's Hospital — Boston, Massachusetts, United States
#115_Henry Ford Hospital — Detroit, Michigan, United States
#102_Mayo Clinic — Rochester, Minnesota, United States
#150_Saint Luke's Hospital — Kansas City, Missouri, United States
#104_Washington University School of Medicine — St Louis, Missouri, United States
#131_University of Nebraska Medical Center — Omaha, Nebraska, United States
#103_Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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