Dynamic Assessment of Right Ventricular Function With Inh... | NCT02220023

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

NCT02220023

Sponsor

Vanderbilt University

Status

Completed

Last Update Posted

Feb 13, 2017Actual

Enrollment

17Actual

Phase

Early Phase 1

Conditions

Pulmonary Vascular Disorder

Interventions

INOmax Inhalation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Aug 14, 2014

First Submission Date that Met QC Criteria

Aug 15, 2014

First Posted Date

Aug 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2017

Last Update Posted Date

Feb 13, 2017Actual

Name	Class
Mallinckrodt	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nitric Oxide	Experimental	40 ppm, one time administration, inhaled.	Drug: INOmax Inhalation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INOmax Inhalation	Drug		Nitric Oxide	nitric oxide NDA 20-845

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure		At time of procedure

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Evan L Brittain, MD	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37232	United States

Intervention Browse Module

MeSH Terms

ID	Term
D009569	Nitric Oxide

Ancestor Terms

ID	Term
D026361	Reactive Nitrogen Species
D005609	Free Radicals
D007287	Inorganic Chemicals
D009589	Nitrogen Oxides

Browse Leaves

Not provided

Browse Branches

Not provided