An Early Phase 1 interventional study of INOmax Inhalation in Pulmonary Vascular Disorder, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-13.
Sponsored by Vanderbilt University · Early Phase 1, Interventional, and Diagnostic
The purpose of the study is to measure RV ejection fraction (RVEF), pulmonary flow, and pulmonary perfusion before and after exposure to inhaled nitric oxide in patients with pulmonary arterial hypertension (PAH) who are known to be vasodilator-responsive based on invasive catheterization as well as healthy subjects. Measurements will also be made after high flow oxygen alone to test the relative vasodilatory effect of oxygen and NO. The investigators hypothesize is that inhaled nitric oxide during cardiac MRI can be used to measure dynamic changes in RV-pulmonary vascular function in patients with vasodilator-responsive PAH.
1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.
This study's enrollment of 17 is below the median of 78 across 639 interventional studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
40 ppm, one time administration, inhaled.
Drug: INOmax Inhalation
Also known as: nitric oxide, NDA 20-845
Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure
Time frame: At time of procedure
Pulmonary flow
Time frame: Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Pulmonary perfusion
Time frame: Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
Estimates of pulmonary vascular resistance
Time frame: At Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
Pulmonary transit time
Time frame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Pulmonary artery compliance
Time frame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Vanderbilt University