Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI

Study Overview
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Brief Summary
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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.

Official Title
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Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI

Conditions
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Pulmonary Vascular Disorder

Intervention / Treatment
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* Drug: INOmax Inhalation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 18 or older of the Vanderbilt Center for Pulmonary Vascular Disease. Vasodilator-responsive patients will be identified based on prior response to inhaled nitric oxide during invasive right heart catheterization Healthy subjects age 18 or older not known to have cardiopulmonary disease Exclusion Criteria: Standard conventional contraindications for cardiac magnetic resonance (CMR) imaging Allergy or contraindication to Magnevist (gadopentetate dimeglumine) contrast Concurrent intravenous epoprostenol infusion in whom performance of CMR is cumbersome Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitric Oxide<br>40 ppm, one time administration, inhaled. | Drug: INOmax Inhalation<br> <br> * Other names: NDA 20-845;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure |  | At time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary flow |  | Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide | 
| Pulmonary perfusion |  | Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide | 
| Estimates of pulmonary vascular resistance |  | At Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide | 
| Pulmonary transit time |  | At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide | 
| Pulmonary artery compliance |  | At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide |