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

Primary Purpose

Pulmonary Vascular Disorder

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
INOmax Inhalation
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Vascular Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nitric Oxide

Arm Description

40 ppm, one time administration, inhaled.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pulmonary flow
Pulmonary perfusion
Estimates of pulmonary vascular resistance
Pulmonary transit time
Pulmonary artery compliance

Full Information

First Posted
August 14, 2014
Last Updated
February 10, 2017
Sponsor
Vanderbilt University
Collaborators
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT02220023
Brief Title
Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI
Acronym
iNO
Official Title
Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Mallinckrodt

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Vascular Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitric Oxide
Arm Type
Experimental
Arm Description
40 ppm, one time administration, inhaled.
Intervention Type
Drug
Intervention Name(s)
INOmax Inhalation
Other Intervention Name(s)
nitric oxide, NDA 20-845
Primary Outcome Measure Information:
Title
Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure
Time Frame
At time of procedure
Secondary Outcome Measure Information:
Title
Pulmonary flow
Time Frame
Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Title
Pulmonary perfusion
Time Frame
Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
Title
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
Title
Pulmonary transit time
Time Frame
At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Title
Pulmonary artery compliance
Time Frame
At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan L Brittain, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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

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