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Completed

NCT Number: NCT00626028

Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing

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.

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Key information

Conditions

Idiopathic Pulmonary Arterial Hypertension Acute Lung Injury Cardiomyopathies Cardiomyopathy Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Familial Primary Pulmonary Hypertension Heart Defects, Congenital Heart Diseases Hypertension, Pulmonary Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

4 week–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Timone - Département de cardiologie, Marseille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Nitric Oxide for Inhalation

Drug

Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system

Other names: INOmax®

Oxygen

Drug

100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system

Nitric Oxide plus Oxygen

Drug

Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system

Other names: Inhaled Nitric Oxide, Oxygen

Primary outcomes

  1. Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)

    Time frame: on Day 1

    A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)

Secondary outcomes

  1. Number of Participants With Related Surgical Procedures Within 1 Year

    Time frame: within 1 year

    Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment.

  2. Number of Participants With Adverse Events (AEs)

    Time frame: 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.

  3. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: 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.

  4. Number of Participants With Related Surgical Procedures Within 3 Years

    Time frame: within 3 years

    Number of participants who received surgery related to pulmonary or cardiac disease within 3 years

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Feb 29, 2008
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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