Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
NCT ID: NCT00626028
Last Updated: 2019-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
136 participants
INTERVENTIONAL
2004-09-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Nitric Oxide First, Oxygen Last
10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1.
Nitric Oxide for inhalation
Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Oxygen
100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Nitric Oxide plus Oxygen
Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
Oxygen First, Nitric Oxide Last
10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.
Nitric Oxide for inhalation
Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Oxygen
100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Nitric Oxide plus Oxygen
Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
Interventions
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Nitric Oxide for inhalation
Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Oxygen
100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Nitric Oxide plus Oxygen
Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
2. Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.
3. Male or female, ages 4 weeks to 18 years, inclusive
4. Signed informed consent/assent
Exclusion Criteria
2. Diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient's pulmonary hypertension.
3. 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
4. Pregnant \[urine human chorionic gonadotropin positive (HCG +)\]
5. Baseline Pulmonary capillary wedge pressure (PCWP) \> 20 mmHg
4 Weeks
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader, MD
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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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
Countries
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References
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Barst RJ, Agnoletti G, Fraisse A, Baldassarre J, Wessel DL; NO Diagnostic Study Group. Vasodilator testing with nitric oxide and/or oxygen in pediatric pulmonary hypertension. Pediatr Cardiol. 2010 Jul;31(5):598-606. doi: 10.1007/s00246-010-9645-5. Epub 2010 Apr 20.
Other Identifiers
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2004-000625-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INOT22
Identifier Type: -
Identifier Source: org_study_id