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Comparison of Inhaled Nitric Oxide Versus Oxygen in Patient Reactivity During Acute Pulmonary Vasodilator Testing

2014-08-27 03:32:33 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Idiopathic Pulmonary Arterial Hypertension

Intervention

Nitric Oxide for inhalation, Oxygen

Location

Lucile Salter Packard Children's Hospital at Stanford
Stanford
California
United States
94304

Status

Completed

Source

INO Therapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:33-0400

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Medical and Biotech [MESH] Definitions

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