Pilot Study of Inhaled Nitric Oxide to Treat Pulmonary Insufficiency in Congenital Heart Disease

• Status: Terminated
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Inhaled nitric oxide in patients with pulmonic valve insufficiency.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Known pulmonary insufficiency status

• Previous Tetralogy of Fallot repair or balloon valvuloplasty/surgical valvotomy for pulmonary stenosis

• Clinically indicated cardiac magnetic resonance imaging study

Exclusion Criteria:

• Enrollment in another clinical trial

• Age less then 18 years

• Inability to provide informed consent

• Institutionalized individual

• Pregnant or lactating

• Serious claustrophobia

• Pacemaker/ICD

• Aneurysm clips

• Internal hardware

• Severe obesity (>350lbs)

• Residual ventricular septal defect

• History of methemoglobinemia

• History of blood dyscrasias

• Acute pulmonary infection

• Pulmonary edema

• Hypersensitivity to nitric oxide or any of its components

• Left ventricle dysfunction (EF<40%)

• Concurrent use of nitroglycerin or prilocaine