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Clinical Trials/NCT02220023
NCT02220023
Completed
Early Phase 1

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

Vanderbilt University1 site in 1 country17 target enrollmentJuly 2014

Overview

Phase
Early Phase 1
Intervention
INOmax Inhalation
Conditions
Pulmonary Vascular Disorder
Sponsor
Vanderbilt University
Enrollment
17
Locations
1
Primary Endpoint
Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
February 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Evan Brittain

Assistant Professor

Vanderbilt University

Eligibility Criteria

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

Arms & Interventions

Nitric Oxide

40 ppm, one time administration, inhaled.

Intervention: INOmax Inhalation

Outcomes

Primary Outcomes

Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure

Time Frame: At time of procedure

Secondary Outcomes

  • Pulmonary transit time(At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide)
  • 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 artery compliance(At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide)

Study Sites (1)

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