Atta Behfar, M.D., Ph.D.

Closed for Enrollment

• 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.

• A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Assess the Safety and Tolerability of JK07 in Subjects With Heart Failure With Preserved Ejection Fraction (HFpEF) Rochester, Minn.

  The purpose of this study is to assess the safety and tolerability profile of JK07, administered intravenously, according to protocol-defined dosing regimen.

• Extracellular Vesicle-based Evaluation of RNA Transcriptomics to Predict Allograft Failure or Treated Episodes of Rejection (EVER AFTER Pilot Study) Rochester, Minn.

  The primary purpose of this study is to evaluate the feasibility of analysis of RNA transcripts from EVs sampled from the coronary sinus.

• Serological Strategy to Optimize Prognostic Stratification in Myocardial Infarction Rochester, Minn.

  Identify novel molecular targets associating clinical findings with ‘omics outputs to create a serum-based approach prognostic of patient baseline MI propensity at the time of MI-related injury

  Identify novel molecular targets associating clinical findings with ‘omics outputs to create a serum-based approach prognostic of heart failure vulnerability at the time of MI-related injury

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

  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.