Effect of iNO in Patients With Submassive and Massive PE

Withdrawn before enrolling · Phase 2

Conditions studied: Pulmonary Embolism, Pulmonary Embolism Subacute Massive

In brief

A single center study to evaluate the effect of inhaled nitric oxide (iNO) on pulmonary dynamics in patients presenting with imaging confirmed intermediate/submassive or massive pulmonary embolism (PE). The target enrollment is 20 subjects at Ronald Reagan UCLA Medical Center. PE patients undergoing catheter-based intervention will be administered iNO during their intervention and pulmonary hemodynamic measurement will be measured before, during, and after iNO administration (Invasive Cohort). Patients who are not undergoing catheter-based intervention will also be administered iNO and will have pulmonary hemodynamics, blood pressure, and heart rate measured non-invasively (Non-Invasive Cohort).

Key facts

Study ID

NCT04996667

Run by

University of California, Los Angeles

People needed

0

Starts

2026-06-01

Expected to finish

2028-06-30

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient ≥ 18 years of age.
• The patient or patient's surrogate decision maker must understand and sign the informed consent form (ICF).
• Hospitalized (Emergency Room (ER) or inpatient) with:
• Imaging (computed tomography pulmonary angiography (CTPA) or ventilation/perfusion (VQ) lung scan) proven acute pulmonary embolism (PE)
• PE meets the following intermediate risk PE criteria (or massive, see below):
• Troponin > .1 AND
• Imaging (computed tomography (CT) or transthoracic echocardiogram (TTE)) signs of RV compromise (at least 1 of the following):
• RV:LV>1 on TTE or CTPA OR RV dilation (TTE or CTPA OR RV dysfunction on TTE.
• Massive PE
• Intensive care unit (ICU) level of care (Patient moving to ICU, ICU level of care in ER, or currently in ICU)
• Ability to comply with study protocol in investigator's judgement

You may not qualify if…

• Pregnancy or breastfeeding
• Inability to administer iNO through current mode of O2 delivery (i.e. BiPAP)
• Active hemoptysis
• Known allergy to iNO.
• Any serious medical condition of lab abnormality that, in the investigator's judgement, precludes the patient's safe participation in the study.
• Methemoglobin reductase deficiency
• Unable to obtain consent or patient or patient surrogate decision maker declines
• Patients already on iNO prior to study enrollment

Where it is running

• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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