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| ID | Type | Description | Link |
|---|---|---|---|
| 1UM1HL113203-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
| University of Mississippi Medical Center | OTHER |
| University of Texas, Southwestern Medical Center at Dallas |
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This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Nitric Oxide | Active Comparator | Inhaled nitric oxide |
|
| Placebo | Placebo Comparator | Oxygen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Nitric Oxide | Drug | Nitric Oxide + oxygen |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Age >/= 18
Pulmonary imaging-proven PE, as interpreted by local radiologist
At least one predictor of RV dysfunction:
Plan to admit to a bed with telemetry capability
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff A Kline, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30633959 | Derived | 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. | |
| 28454823 | Derived | Kline 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Nitric Oxide | Inhaled nitric oxide Nitric Oxide + oxygen |
| FG001 | Sham | oxygen Nitrogen + Oxygen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Nitric Oxide | Inhaled nitric oxide Nitric Oxide + oxygen |
| BG001 | Sham | oxygen Nitrogen + Oxygen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 5 days or hospital discharge (whichever occurs first) |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhaled Nitric Oxide | Inhaled nitric oxide Nitric Oxide + oxygen | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arrhythmia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey A. Kline, MD | Indiana University | 317-880-3900 | jefkline@iu.edu |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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| Sham |
| Drug |
Nitrogen + Oxygen |
|
|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| University of Mississippi | Jackson | Mississippi | 36216 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
oxygen
Nitrogen + Oxygen
|
|
| 38 |
| 2 |
| 38 |
| 12 |
| 38 |
| EG001 | Sham | oxygen Nitrogen + Oxygen | 2 | 38 | 2 | 38 | 11 | 38 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |