MILWAUKEE, Oct. 12 /PRNewswire/ -- Aurora St. Luke's Medical Center has begun an open label, non-randomized pilot research study to evaluate the safety, tolerability and device performance of the GeNO NITROsyl™ Delivery System during right heart catheterization in subjects being evaluated for orthotopic heart transplantation (OHT) and left ventricular assist device (LVAD) implantation. The study will be the first to evaluate the change in hemodynamic variables following the delivery of inhaled nitric oxide (NO). A key feature is that the nitric oxide delivered to the patient contains very low levels of a ubiquitous toxic impurity, nitrogen dioxide (NO2), that is normally co-delivered with nitric oxide.
The trial will enroll 10 participants and aims to test whether the use of nitric oxide that is entirely free of NO2 results in a reduction in pulmonary hypertension due to increased pulmonary vascular resistance in patients with chronic heart failure. Enrolled patients must be scheduled for a right heart catheterization to evaluate pulmonary vascular resistance (PVR) and trans pulmonary gradient (TPG) prior to OHT or LVAD implantation. The primary endpoint of the study will include the incidence and severity of treatment adverse events, unanticipated adverse device effects, and changes from baseline to end-of-study in clinical laboratory parameters and vital signs. The secondary endpoint will include the change from baseline to end-of-hemodynamic assessment for a number of hemodynamic variables.
"Nitric oxide has a promising therapeutic potential in numerous disease states and in particular among diseases of the respiratory system," said Dr. Andrew Boyle, medical director of heart failure, cardiac transplantation and mechanical circulatory support at Aurora St. Luke's. "The use of inhaled nitric oxide, free of NO2, provides a unique opportunity to significantly impact the medical management of patients scheduled to undergo heart transplant and placement of left ventricular assist devices. We hope to advance the potential of nitric oxide in our pilot study, and show that the system could also help address the cost, complexity and the lack of portability of current treatment options, and ultimately benefit a larger group of patients."
The use of inhaled nitric oxide in patients with pulmonary hypertension has been extensively reported in literature, including several studies that have successfully used nitric oxide to assess vasoreactivity in patients during right heart catheterization. Inhaled nitric oxide is commonly used by clinicians off-label as part of the evaluation and acute management of pulmonary hypertension patients, and is used as a supportive therapy in a number of life-threatening conditions, including pulmonary edema and hypertension secondary to heart failure. As a short-lived, gaseous, and vasoreactive molecule with an extensive safety profile, nitric oxide also has a promising utility as a diagnostic agent.
Aurora Health Care is a not-for-profit Wisconsin based health care provider and a national leader in efforts to improve the quality of care. Aurora provides care at sites in more than 90 communities throughout eastern Wisconsin and northern Illinois.
Adam V. Beeson
Online newsroom: www.Aurora.org/Newsroom
SOURCE Aurora Health Care