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

NCT02220023 | Completed Early Phase 1

• 1 other identifier: 140068
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Vascular Disorder

Outcome Measures

Primary Outcomes (1)

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

  At time of procedure

Secondary Outcomes (5)

• 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

Study Arms (1)

Nitric Oxide

EXPERIMENTAL

40 ppm, one time administration, inhaled.

Drug: INOmax Inhalation

Interventions

INOmax Inhalation DRUG

Also known as: nitric oxide, NDA 20-845

Nitric Oxide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• Mallinckrodt: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Nitric Oxide

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Evan L Brittain, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 19, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 13, 2017

Record last verified: 2017-02

Locations

US (1)