Clinical Trial: Nitric Oxide to Treat Pulmonary Embolism

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Indiana University School of Medicine

Current Primary Outcome: RV function and viability [ Time Frame: 5 days or hospital discharge (whichever occurs first) ]

RV function and viability assessed by the composite of normal RV size (<42 mm in diastole) and TAPSE > 16 mm and normal RIMP < 0.40 using spectral Doppler or < 0.55 using tissue Doppler) and normal FAC (> 33%) and a serum hsTnT < 14pg/mL. Missing values will be considered normal.


Original Primary Outcome: RV function and viability [ Time Frame: 5 days or hospital discharge (whichever occurs first) ]

RV function and viability assessed by the composite of normal RV size (<42 mm in diastole) and TAPSE > 16 mm and RIMP > 0.40(echocardiograph systolic measurements for RV) and serum hsTnT < 14pg/mL.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Indiana University

Dates:
Date Received: August 28, 2013
Date Started: October 2013
Date Completion: February 2018
Last Updated: March 30, 2017
Last Verified: March 2017