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

Stopped early · Early Phase 1

Conditions studied: Pulmonary Insufficiency

In brief

Inhaled nitric oxide in patients with pulmonic valve insufficiency.

Key facts

Study ID

NCT00543933

Run by

The Cleveland Clinic

People needed

18

Starts

2007-10-01

Expected to finish

2010-06-01

Last updated by the study team

2017-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Known pulmonary insufficiency status
• Previous Tetralogy of Fallot repair or balloon valvuloplasty/surgical valvotomy for pulmonary stenosis
• Clinically indicated cardiac magnetic resonance imaging study

You may not qualify if…

• 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

Where it is running

• The Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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