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A minimum of 100 patients will be enrolled in the study to demonstrate which diagnostic treatment (oxygen or nitric oxide) is most capable of identifying patients with a reactive pulmonary vascular bed. Each patient will be given all three treatment regimen, nitric oxide, oxygen, and the comparison treatment (either nitric oxide or oxygen), with a wash out period of 10 minutes between each dose. Patients will be randomized at the time of enrollment to determine which comparison treatment they will receive.
This is an open, randomized, prospective, multi-center study designed to demonstrate which diagnostic treatment is most capable of identifying patients with a reactive pulmonary vascular bed. A minimum of 100 patients will be enrolled in the study to compare the number of patients with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen. This primary objective will be obtained by measuring the decrease in PAPm ≥ 20% and no decrease in cardiac index (within 5%) in patients with Idiopathic Pulmonary Arterial Hypertension (IPAH) or Congenital Heart Disease (CHD) who do not have an unrestricted shunt at the level of the ventricle or ductus arteriosus, and by measuring the decrease in PAPm ≥ 20% and no decrease in cardiac index (within 5%) and decrease in PVRI ≥ 25% and no decrease in cardiac index (within 5%) in patients with cardiomyopathy or CHD who have unrestricted shunt at the level of the ventricle or ductus arteriosus. Additionally, comparison of the incidence and types of drug related and serious adverse events as well as the number of patients with reversible pulmonary hypertension due to metric oxide for inhalation alone compared to 100% oxygen and to oxygen with nitric oxide for inhalation will also be assessed.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Idiopathic Pulmonary Arterial Hypertension
Nitric Oxide for inhalation, Oxygen
Lucile Salter Packard Children's Hospital at Stanford
Published on BioPortfolio: 2014-08-27T03:32:33-0400
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An NADPH-dependent enzyme that catalyzes the conversion of L-ARGININE and OXYGEN to produce CITRULLINE and NITRIC OXIDE.
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A CALCIUM-dependent, constitutively-expressed form of nitric oxide synthase found primarily in NERVE TISSUE.
A CALCIUM-dependent, constitutively-expressed form of nitric oxide synthase found primarily in ENDOTHELIAL CELLS.
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