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

INO Therapeutics0 个研究点目标入组 150 人开始时间: 2005年2月10日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•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

•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 +).
•5. Baseline PCWP > 20 mmHG.

发起方

INO Therapeutics