Status:
COMPLETED
Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
Lead Sponsor:
Mallinckrodt
Conditions:
Idiopathic Pulmonary Arterial Hypertension
Cardiomyopathy
Eligibility:
All Genders
4-18 years
Phase:
PHASE3
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% oxy...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00626028
Start Date
September 1 2004
End Date
February 1 2010
Last Update
December 20 2019
Active Locations (18)
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1
Lucile Salter Packard Children's Hospital at Stanford
Stanford, California, United States, 94304
2
The Children's Hospital
Denver, Colorado, United States, 80218
3
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
4
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110