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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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)

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 range

18 Years

Sex

ALL

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)