Clinical trial NCT00626028: Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
Official title: Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Pulmonary Arterial Hypertension
Cardiomyopathy
Keywords: Pulmonary Vasculature
Nitric Oxide
INOmax®
Acute Lung Injury
Pulmonary Vasodilator Testing
Idiopathic Pulmonary Arterial Hypertension
Congenital Heart Disease
reversible pulmonary hypertension
vasoreactivity
Congenital Heart Disease with Pulmonary Hypertension
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 136
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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% oxygen.


Eligibility criteria: Inclusion Criteria:

1. 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
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:

1. Focal pulmonary infiltrates on chest radiograph.
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

Primary outcomes:
measure: Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)
timeFrame: on Day 1
Secondary outcomes:
measure: Number of Participants With Related Surgical Procedures Within 1 Year
timeFrame: within 1 year
measure: Number of Participants With Adverse Events (AEs)
timeFrame: on Day 1
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: within 12 hours
measure: Number of Participants With Related Surgical Procedures Within 3 Years
timeFrame: within 3 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Salter Packard Children's Hospital at Stanford
state: California
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Columbus Children's Hospital
state: Ohio
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
city: Marseille
country: France
facility: CHU Timone - Département de cardiologie
city: Nancy
country: France
facility: Hôpital d'Enfants
city: Paris
country: France
facility: Hôpital NECKER - Enfants Malades
city: Groningen
country: Netherlands
facility: Beatrix Children's Hospital / University Hospital Groningen
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu de Barcelona
city: Barcelona
country: Spain
facility: Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
city: Madrid
country: Spain
facility: Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospitals Trust - Wessex Cardiothoracic Centre
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader, MD
role: STUDY_DIRECTOR
References:
citation: 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.