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

Early Phase 1

Completed

• Conditions: Pulmonary Vascular Disorder
• Interventions: Drug: INOmax Inhalation

• Registration Number: NCT02220023
• Lead Sponsor: Vanderbilt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-19
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nitric Oxide	INOmax Inhalation	40 ppm, one time administration, inhaled.

Primary Outcome Measures

Name	Time	Method
Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure	At time of procedure

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States