Conditions: Idiopathic Pulmonary Arterial Hypertension Cardiomyopathy
Keywords: Pulmonary Vasculature Nitric Oxide INOmax® Acute Lung Injury Pulmonary Vasodilator Testing Idiopathic Pulmonary Arterial Hypertension Congenital Heart Disease reversible pulmonary hypertension vasoreactivity Congenital Heart Disease with Pulmonary Hypertension
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 136
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.

Detailed description:

Arms:
arm 1: 10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1. arm 2: 10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.

Interventions: intervention 1: Nitric Oxide for inhalation intervention 2: Oxygen intervention 3: Nitric Oxide plus Oxygen
Intervention descriptions: intervention 1: Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system intervention 2: 100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system intervention 3: Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system

Protocol document: