A Phase 2 interventional study of Inhaled Nitric Oxide and Sham in Pulmonary Embolism, sponsored by Indiana University School of Medicine. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-03.
Sponsored by Indiana University School of Medicine · Phase 2, Interventional, and Treatment
This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).
This is a randomized, double blind study to treat subjects diagnosed with pulmonary embolism with inhaled nitrix oxide. In this clinical trial investigators will randomized patients to receive inhaled nitric oxide or sham (nitrogen + oxygen) for 24 hours. Patients must have a submassive pulmonary embolism (PE) and evidence of right ventricular (RV) heart dysfunction. Investigators hypothesize that the administration of inhaled NO + oxygen to patients with severe submassive PE will improve RV function, reduce RV strain and necrosis and improve dyspnea (difficulty breathing) more than sham oxygen treatment.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 78 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
At least one predictor of RV dysfunction:
Exclusion Criteria:
Inhaled nitric oxide
Drug: Inhaled Nitric Oxide
Oxygen
Drug: Sham
Nitric Oxide + oxygen
Nitrogen + Oxygen
Also known as: placebo, oxygen
Number of Participants With Normal Right Ventricular (RV) Function and Viability
Right ventricular (RV) function and viability assessed by the composite of normal RV size (\<42 mm in diastole) and tricuspid annular plane systolic excursion (TAPSE) \> 16 mm and normal right ventricular index of myocardial performance (RIMP) \< 0.40 using spectral Doppler or \< 0.55 using tissue Doppler) and normal fractional area change (FAC) (\> 33%) and a serum hsTnT \< 14pg/mL. Missing values will be considered normal.
Time frame: 5 days or hospital discharge (whichever occurs first)
| Milestone | Inhaled Nitric Oxide | Sham |
|---|---|---|
| Started | 39 | 39 |
| Completed | 38 | 38 |
| Not completed | 1 | 1 |
Right ventricular (RV) function and viability assessed by the composite of normal RV size (\<42 mm in diastole) and tricuspid annular plane systolic excursion (TAPSE) \> 16 mm and normal right ventricular index of myocardial performance (RIMP) \< 0.40 using spectral Doppler or \< 0.55 using tissue Doppler) and normal fractional area change (FAC) (\> 33%) and a serum hsTnT \< 14pg/mL. Missing values will be considered normal.
| Participants | Inhaled Nitric Oxide | Sham |
|---|---|---|
| Number of Participants With Normal Right Ventricular (RV) Function and Viability | 9 | 5 |
Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inhaled Nitric Oxide | 2/38 (5.3%) | 2/38 (5.3%) | 12/38 (31.6%) |
| Sham | 2/38 (5.3%) | 2/38 (5.3%) | 11/38 (28.9%) |
| Event | Inhaled Nitric Oxide | Sham |
|---|---|---|
| deathRespiratory, thoracic and mediastinal disorders | 2/38 | 2/38 |
| Event | Inhaled Nitric Oxide | Sham |
|---|---|---|
| arrhythmiaCardiac disorders | 12/38 | 11/38 |
| Age, Continuous(years) | Inhaled Nitric Oxide | Sham | Total |
|---|---|---|---|
| Mean | 55 ± 15 | 59 ± 16 | 57 ± 15 |
| Sex: Female, Male(Participants) | Inhaled Nitric Oxide | Sham | Total |
|---|---|---|---|
| Female | 21 | 20 | 41 |
| Male | 18 | 19 | 37 |
| Region of Enrollment(Participants) | Inhaled Nitric Oxide | Sham | Total |
|---|---|---|---|
| United States | 39 | 39 | 78 |
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Indiana University School of Medicine