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Trial record 1 of 1 for:    NCT02220023
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Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI (iNO)

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ClinicalTrials.gov Identifier: NCT02220023
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Evan Brittain, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Vascular Disorder Drug: INOmax Inhalation Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI
Study Start Date : July 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nitric Oxide
40 ppm, one time administration, inhaled.
Drug: INOmax Inhalation
Other Names:
  • nitric oxide
  • NDA 20-845




Primary Outcome Measures :
  1. Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure [ Time Frame: At time of procedure ]

Secondary Outcome Measures :
  1. Pulmonary flow [ Time Frame: Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide ]
  2. Pulmonary perfusion [ Time Frame: Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide ]
  3. 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 ]
  4. Pulmonary transit time [ Time Frame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide ]
  5. Pulmonary artery compliance [ Time Frame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220023


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Mallinckrodt
Investigators
Principal Investigator: Evan L Brittain, MD Vanderbilt University Medical Center

Responsible Party: Evan Brittain, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02220023     History of Changes
Other Study ID Numbers: 140068
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents