Nitric Oxide to Treat Pulmonary Embolism

Study Overview
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Brief Summary
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This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).

Detailed Description
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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.

Official Title
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Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Drug: Inhaled Nitric Oxide
* Drug: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/= 18 Pulmonary imaging-proven PE, as interpreted by local radiologist At least one predictor of RV dysfunction: echocardiography with RV dilation or hypokinesis, estimated RVSP >40mm HG, RV>LV on CTPA, elevated troponin I (>0.1 ng/mL) or natriuretic peptide (BNP > 90 pg/mL), screening bedside cardiac ultrasound with color flow capability that shows RV dysfunction, RV strain on ECG Plan to admit to a bed with telemetry capability Exclusion Criteria: Vasopressor support at time of enrollment Pregnancy Plan by clinical care team to use lytic or surgical embolectomy Plan by clinical team to use platelet inhibiting drugs Contraindication to anticoagulation Altered mental status such that the patient is unable to provide informed consent Inability to use a nasal cannula or face mask Comfort care measures instituted Supplemental oxygen requirements greater than can be administered via nasal cannula in order to maintain Sa)2 > 80% Pneumothorax with decompression Serum MetHb > 10% Recent use of drugs known to increase cGMP Use of nitroprusside or nitroglycerin within the last 4 hours Use of any other nitrates with in the past 24 hours Use of a fibrinolytic medicine within the past 14 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inhaled Nitric Oxide<br>Inhaled nitric oxide | Drug: Inhaled Nitric Oxide<br>* Nitric Oxide + oxygen<br>|
| Placebo Comparator: Placebo<br>Oxygen | Drug: Sham<br>* Nitrogen + Oxygen<br>* Other names: oxygen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 days or hospital discharge (whichever occurs first) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary embolism clot