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

Pulmonary Vascular Disorder Clinical Trial

— iNO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220023
• Other study ID #: 140068
• Status: Completed
• Phase: Early Phase 1
• First received: August 14, 2014
• Last updated: February 10, 2017
• Start date: July 2014
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Vascular Disorder
• Vascular Diseases

Intervention

Drug:
• INOmax Inhalation

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure		At time of procedure
Secondary	Pulmonary flow		Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Secondary	Pulmonary perfusion		Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
Secondary	Estimates of pulmonary vascular resistance		At Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
Secondary	Pulmonary transit time		At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Secondary	Pulmonary artery compliance		At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide