WithdrawnPhase 2

Effect of iNO in Patients With Submassive and Massive PE

Stopped: no sponsor support

United States0Started 2026-06-01

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

right atrial pressure (RAP)

Timeframe: measured invasively during a right heart catheterization (RHC) before administration of iNO

right atrial pressure (RAP)

Timeframe: measured invasively during a right heart catheterization (RHC) during administration of iNO

right atrial pressure (RAP)

Timeframe: measured invasively during a right heart catheterization (RHC) after administration of iNO

right ventricular pressure (RVP)

Timeframe: measured invasively during a right heart catheterization (RHC) before administration of iNO

right ventricular pressure (RVP)

Timeframe: measured invasively during a right heart catheterization (RHC) during administration of iNO

right ventricular pressure (RVP)

Timeframe: measured invasively during a right heart catheterization (RHC) after administration of iNO

pulmonary arterial pressure (PAP)

Timeframe: measured invasively during a right heart catheterization (RHC) before administration of iNO

Trial details

NCT IDNCT04996667

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Pulmonary Embolism trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

right atrial pressure (RAP)

Timeframe: measured invasively during a right heart catheterization (RHC) before administration of iNO

right atrial pressure (RAP)

Timeframe: measured invasively during a right heart catheterization (RHC) during administration of iNO

right atrial pressure (RAP)

Timeframe: measured invasively during a right heart catheterization (RHC) after administration of iNO

right ventricular pressure (RVP)

Timeframe: measured invasively during a right heart catheterization (RHC) before administration of iNO

right ventricular pressure (RVP)

Timeframe: measured invasively during a right heart catheterization (RHC) during administration of iNO

right ventricular pressure (RVP)

Timeframe: measured invasively during a right heart catheterization (RHC) after administration of iNO

pulmonary arterial pressure (PAP)

Timeframe: measured invasively during a right heart catheterization (RHC) before administration of iNO