Pulmonary Vascular DisorderEarly Phase 1iNONCT02220023
Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI
A Early Phase 1 study testing INOmax Inhalation in people with Pulmonary Vascular Disorder, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Vascular Disorder
- What is being tested?
- INOmax Inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Feb 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
- Conditions
- Pulmonary Vascular Disorder
- Being tested
- INOmax Inhalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INOmax InhalationDrug
Also called nitric oxide, NDA 20-845
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide | Experimental | 40 ppm, one time administration, inhaled. Receives: Drug: INOmax Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure
Measured: At time of procedure
Secondary outcomes (5)
Pulmonary flow
Measured: Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Pulmonary perfusion
Measured: Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
Estimates of pulmonary vascular resistance
Measured: At Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
Pulmonary transit time
Measured: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Pulmonary artery compliance
Measured: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Vascular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Principal investigator, Evan Brittain, Vanderbilt University
- Investigators
- Evan L Brittain, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220023
- Sponsor's protocol ID
- 140068
- Acronym
- iNO
- Status last verified
- Feb 2017
- First submitted
- 14 Aug 2014
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI
- ClinicalTrials.gov ID
- NCT02220023
- Acronym / sponsor ID
- iNO / 140068
- Conditions
- Pulmonary Vascular Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Jul 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide | Experimental | Drug: INOmax Inhalation40 ppm, one time administration, inhaled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INOmax InhalationAlso: nitric oxide, NDA 20-845 | Drug | Nitric Oxide |
Primary outcome
Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure
Time frame: At time of procedure
5 secondary outcomes
Pulmonary flow
Time frame: Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Pulmonary perfusion
Time frame: Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
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
Pulmonary transit time
Time frame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Pulmonary artery compliance
Time frame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan L Brittain, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing INOmax Inhalation in people with Pulmonary Vascular Disorder, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure (time frame: At time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017; AzTrials last refreshed its copy on 1 Nov 2026.