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 - N/A

Phase 1

• Conditions: : Nitric Oxide for inhalation at 800ppm, plus 100% O2, to be used to assess pulmonary vaso reactivity during Pulmonary Vasodilator Testing

• Registration Number: EUCTR2004-000625-30-ES
• Lead Sponsor: INO Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-09-16
• Study Completion: 2010-02-01
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

The patient must meet the following criteria:
1. Have any one of the three disease categories:
a. Idiopathic Pulmonary Arterial Hypertension
i. PAPm › 25mmHg at rest, PCWP = 15mmHg, and PVRI › 3 u· m2 or diagnosed clinically with no previous catheterization.
b. CHD with pulmonary hypertension repaired and unrepaired,
i. PAPm › 25mmHg at rest, and PVRI › 3 u· m2 or diagnosed clinically with no previous catheterization
c. Cardiomyopathy
i. PAPm › 25mmHg at rest, and PVRI › 3 u•m2 or diagnosed clinically with no previous catheterization.
2. Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.
3. Males or females, ages 4 weeks to 18 years, inclusive
4. Signed IRB/IEC approved informed consent (and assent if applicable).

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The patient will be excluded from enrolment if any of the following are true:
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, or are on other investigational medications, nitroglycerin, sodium nitroprusside, sildenafil, other PDE-5 inhibitors, or prostacyclin.
4. Pregnant (urine HCG +).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified