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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-02-28

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.

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Detailed Description

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Conditions

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Pulmonary Vascular Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Nitric Oxide

40 ppm, one time administration, inhaled.

Group Type EXPERIMENTAL

INOmax Inhalation

Intervention Type DRUG

Interventions

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INOmax Inhalation

Intervention Type DRUG

Other Intervention Names

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nitric oxide NDA 20-845

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No