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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02220023

Acronym

iNO

Enrollment

Registered

2014-08-19

Start date

2014-07-31

Completion date

2017-02-28

Last updated

2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Vascular Disorder

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.

Interventions

DRUGINOmax Inhalation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	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
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026