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  • 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 (Soprano) Rochester, Minn.

    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.

  • Zinc Versus Multivitamin Micronutrient Supplementation to Support Immune Health in the Setting of COVID-19 Pandemic: A randomized study (Zn COVID Study) Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

    The purpose of this study is compare high dose (69.6 mg/day) Zinc to multivitamin supplementation on immune health as used by primary health care staff and individuals over 50 years old identified, by hypothesis generated from observations among the pandemic to date, as being at risk populations to COVID-19. In order to ensure consistent nutritional supplementation, the PreserVision AREDS formulation gel tabs will be recommended for those randomized to Zinc and the Adult (under 50) Centrum formulation recommended for those randomized to multivitamin.

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