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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00626028
• Date of registration: 20/02/2008
• Prospective Registration: No
• Primary sponsor: Mallinckrodt
• Public title: Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
• Scientific 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
• Date of first enrolment: September 2004
• Target sample size: 136
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00626028
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: Global Clinical Leader, MD
• Affiliation: Mallinckrodt

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cardiomyopathy

Idiopathic Pulmonary Arterial Hypertension

Intervention(s)

Drug: Oxygen

Drug: Nitric Oxide for inhalation

Drug: Nitric Oxide plus Oxygen

Primary Outcome(s)

Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity) [Time Frame: on Day 1]

Secondary Outcome(s)

Number of Participants With Related Surgical Procedures Within 3 Years [Time Frame: within 3 years]

Number of Participants With Related Surgical Procedures Within 1 Year [Time Frame: within 1 year]

Number of Participants With Serious Adverse Events (SAEs) [Time Frame: within 12 hours]

Number of Participants With Adverse Events (AEs) [Time Frame: on Day 1]

Secondary ID(s)

INOT22

2004-000625-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/09/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00626028