Nitric Oxide to Treat Pulmonary Embolism
Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
2 other identifiers
interventional
78
1 country
4
Brief Summary
This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2013
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2016
CompletedResults Posted
Study results publicly available
March 29, 2018
CompletedOctober 3, 2018
September 1, 2018
3.1 years
August 28, 2013
January 23, 2018
September 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Inhaled Nitric Oxide
ACTIVE COMPARATORInhaled nitric oxide
Placebo
PLACEBO COMPARATOROxygen
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana University School of Medicinelead
- Mallinckrodtcollaborator
- National Institutes of Health (NIH)collaborator
- University of Mississippi Medical Centercollaborator
- University of Texas, Southwestern Medical Center at Dallascollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (4)
Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Methodist Hospital
Indianapolis, Indiana, 46202, United States
University of Mississippi
Jackson, Mississippi, 36216, United States
Related Publications (2)
Kline JA, Puskarich MA, Jones AE, Mastouri RA, Hall CL, Perkins A, Gundert EE, Lahm T. Inhaled nitric oxide to treat intermediate risk pulmonary embolism: A multicenter randomized controlled trial. Nitric Oxide. 2019 Mar 1;84:60-68. doi: 10.1016/j.niox.2019.01.006. Epub 2019 Jan 8.
PMID: 30633959DERIVEDKline JA, Hall CL, Jones AE, Puskarich MA, Mastouri RA, Lahm T. Randomized trial of inhaled nitric oxide to treat acute pulmonary embolism: The iNOPE trial. Am Heart J. 2017 Apr;186:100-110. doi: 10.1016/j.ahj.2017.01.011. Epub 2017 Jan 27.
PMID: 28454823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey A. Kline, MD
- Organization
- Indiana University
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff A Kline, MD
Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chair of Research
Study Record Dates
First Submitted
August 28, 2013
First Posted
September 11, 2013
Study Start
October 1, 2013
Primary Completion
October 31, 2016
Study Completion
October 31, 2016
Last Updated
October 3, 2018
Results First Posted
March 29, 2018
Record last verified: 2018-09