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Completed

NCT Number: NCT02220023

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

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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Key information

Conditions

Pulmonary Vascular Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INOmax Inhalation

Drug

Other names: nitric oxide, NDA 20-845

Primary outcomes

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

    Time frame: At time of procedure

Secondary outcomes

  1. Pulmonary flow

    Time frame: Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide

  2. Pulmonary perfusion

    Time frame: Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide

  3. 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

  4. Pulmonary transit time

    Time frame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide

  5. Pulmonary artery compliance

    Time frame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Mallinckrodt

Registry information

Acronym: iNO

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 19, 2014
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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