Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hyperte… (NCT02554903) | Clinical Trial Compass
CompletedPhase 2
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
United States57 participantsStarted 2016-03-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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.
What they're measuring
1
Pulmonary Vascular Resistance (PVR) Ratio of Week 12 to Baseline