NCT00782652

The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients

The Effects of Nitric Oxide for Inhalation on Survival or the Need for Dialysis or a Right Ventricular Assistance Device (RVAD) in Right Ventricular Infarction Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to better understand the effects of nitric oxide, a gas for inhalation, on patients with right ventricular infarction.

Detailed description

This is a prospective, randomized, double-blind, placebo-controlled study that will assess the feasibility of studying inhaled nitric oxide for the treatment of cardiogenic shock due to right ventricular infarction, and the dose response of the acute hemodynamic changes occurring with nitric oxide inhalation in these patients. Patients with evidence of right ventricular infarction and cardiogenic shock, and have angiographic evidence of impaired blood flow to the right ventricle, or if right ventricular coronary perfusion is unimpared, cardiac shock persists, will be eligible for enrollment. Patients will receive standard of care for their condition, and will also recieve either nitric oxide for inhalation or placebo for up to 14 days.

Conditions

• Right Ventricular Infarction

Interventions

Type	Name	Description
DRUG	inhaled nitric oxide	Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days
DRUG	nitrogen gas	Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2008-10-31
• Last updated: 2016-09-09

Locations

6 sites across 5 countries: United States, Belgium, Canada, Poland, Spain