Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
Completed · Phase 3
Conditions studied: Idiopathic Pulmonary Arterial Hypertension, Cardiomyopathy
In brief
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.
Key facts
- Study ID
- NCT00626028
- Run by
- Mallinckrodt
- People needed
- 136
- Starts
- 2004-09-01
- Expected to finish
- 2010-02-01
- Last updated by the study team
- 2019-12-20
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must have any one of these three disease categories:
- Idiopathic Pulmonary Arterial Hypertension
- Mean pulmonary arterial pressure (PAPm) > 25 millimeters of mercury (mmHg) at rest, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and PVRI> 3 u•m\^2 or diagnosed clinically with no previous catheterization
- Congenital heart disease (CHD) with pulmonary hypertension repaired and unrepaired
- PAPm > 25 mmHg at rest and PVRI> 3 u•m\^2 or diagnosed clinically with no previous catheterization
- Cardiomyopathy
- PAPm > 25 mmHg at rest and Pulmonary vascular resistance index (PVRI)> 3 u•m\^2 or diagnosed clinically with no previous catheterization
- Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.
- Male or female, ages 4 weeks to 18 years, inclusive
- Signed informed consent/assent
You may not qualify if…
- Focal pulmonary infiltrates on chest radiograph.
- Diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient's pulmonary hypertension.
- Received treatment with nitric oxide for inhalation within 30 days prior to study initiation, are on other investigational medications, nitroglycerin, sodium nitroprusside, sildenafil, other Phosphodiesterase type 5 (PDE-5) inhibitors, or prostacyclin
- Pregnant [urine human chorionic gonadotropin positive (HCG +)]
- Baseline Pulmonary capillary wedge pressure (PCWP) > 20 mmHg
Where it is running
- Lucile Salter Packard Children's Hospital at Stanford — Stanford, California, United States
- The Children's Hospital — Denver, Colorado, United States
- Children's Hospital Boston — Boston, Massachusetts, United States
- St. Louis Children's Hospital — St Louis, Missouri, United States
- New York Presbyterian Hospital — New York, New York, United States
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States
- Columbus Children's Hospital — Columbus, Ohio, United States
- The Medical University of South Carolina — Charleston, South Carolina, United States
- CHU Timone - Département de cardiologie — Marseille, France
- Hôpital d'Enfants — Nancy, France
- Hôpital NECKER - Enfants Malades — Paris, France
- Beatrix Children's Hospital / University Hospital Groningen — Groningen, Netherlands
- Hospital Sant Joan de Déu de Barcelona — Barcelona, Spain
- Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón — Barcelona, Spain
- Hospital Gregorio Maranon — Madrid, Spain
- Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre — Madrid, Spain
- Royal Brompton Hospital — London, United Kingdom
- Southampton University Hospitals Trust - Wessex Cardiothoracic Centre — Southampton, United Kingdom
Full record on ClinicalTrials.gov
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