Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
- Conditions
- Idiopathic Pulmonary Arterial HypertensionCardiomyopathy
- Interventions
- Registration Number
- NCT00626028
- Lead Sponsor
- Mallinckrodt
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oxygen First, Nitric Oxide Last Nitric Oxide for inhalation 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. Oxygen First, Nitric Oxide Last Oxygen 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 First, Oxygen Last Nitric Oxide for inhalation 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 First, Oxygen Last Oxygen 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 First, Oxygen Last Nitric Oxide plus Oxygen 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. Oxygen First, Nitric Oxide Last Nitric Oxide plus Oxygen 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity) on Day 1 A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)
- Secondary Outcome Measures
Name Time Method Number of Participants With Related Surgical Procedures Within 1 Year within 1 year Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment.
Number of Participants With Adverse Events (AEs) on Day 1 An AE was defined as any untoward medical occurrence. An AE need not have a causal relationship with treatment and included any event that was not seen at baseline or, if present at baseline, increased in severity.
Number of Participants With Serious Adverse Events (SAEs) within 12 hours SAEs were collected during the 12 hours after discontinuation of gas or discharge (whichever came first). An SAE was defined as any event that resulted in death, was life threatening, resulted in permanent disability or incapacity, required or prolonged inpatient hospitalization, or was a congenital anomaly. Important medical events that, without medical or surgical intervention, would also have resulted in one of the outcomes listed above were also considered as SAEs.
Number of Participants With Related Surgical Procedures Within 3 Years within 3 years Number of participants who received surgery related to pulmonary or cardiac disease within 3 years
Trial Locations
- Locations (18)
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
CHU Timone - Département de cardiologie
🇫🇷Marseille, France
Hospital Gregorio Maranon
🇪🇸Madrid, Spain
Southampton University Hospitals Trust - Wessex Cardiothoracic Centre
🇬🇧Southampton, United Kingdom
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Hospital Sant Joan de Déu de Barcelona
🇪🇸Barcelona, Spain
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Hôpital d'Enfants
🇫🇷Nancy, France
Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre
🇪🇸Madrid, Spain
Hôpital NECKER - Enfants Malades
🇫🇷Paris, France
Lucile Salter Packard Children's Hospital at Stanford
🇺🇸Stanford, California, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón
🇪🇸Barcelona, Spain
Beatrix Children's Hospital / University Hospital Groningen
🇳🇱Groningen, Netherlands
The Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
The Children's Hospital
🇺🇸Denver, Colorado, United States
Royal Brompton Hospital
🇬🇧London, United Kingdom