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Nitric Oxide to Treat Pulmonary Embolism

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inhaled Nitric Oxide
Sham
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Pulmonary embolism clot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >/= 18
  • Pulmonary imaging-proven PE, as interpreted by local radiologist

  • At least one predictor of RV dysfunction:

    1. echocardiography with RV dilation or hypokinesis,
    2. estimated RVSP >40mm HG,
    3. RV>LV on CTPA,
    4. elevated troponin I (>0.1 ng/mL) or natriuretic peptide (BNP > 90 pg/mL),
    5. screening bedside cardiac ultrasound with color flow capability that shows RV dysfunction,
    6. RV strain on ECG
  • Plan to admit to a bed with telemetry capability

Exclusion Criteria:

  • 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

Sites / Locations

  • Eskenazi Hospital
  • Indiana University Hospital
  • Methodist Hospital
  • University of Mississippi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Inhaled Nitric Oxide

Placebo

Arm Description

Inhaled nitric oxide

Oxygen

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 28, 2013
Last Updated
September 6, 2018
Sponsor
Indiana University School of Medicine
Collaborators
Mallinckrodt, National Institutes of Health (NIH), University of Mississippi Medical Center, University of Texas, Southwestern Medical Center at Dallas, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01939301
Brief Title
Nitric Oxide to Treat Pulmonary Embolism
Official Title
Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 31, 2016 (Actual)
Study Completion Date
October 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University School of Medicine
Collaborators
Mallinckrodt, National Institutes of Health (NIH), University of Mississippi Medical Center, University of Texas, Southwestern Medical Center at Dallas, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Pulmonary embolism clot

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Nitric Oxide
Arm Type
Active Comparator
Arm Description
Inhaled nitric oxide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oxygen
Intervention Type
Drug
Intervention Name(s)
Inhaled Nitric Oxide
Intervention Description
Nitric Oxide + oxygen
Intervention Type
Drug
Intervention Name(s)
Sham
Other Intervention Name(s)
placebo, oxygen
Intervention Description
Nitrogen + Oxygen
Primary Outcome Measure Information:
Title
Number of Participants With Normal Right Ventricular (RV) Function and Viability
Description
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.
Time Frame
5 days or hospital discharge (whichever occurs first)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff A Kline, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
36216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30633959
Citation
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.
Results Reference
derived
PubMed Identifier
28454823
Citation
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.
Results Reference
derived

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Nitric Oxide to Treat Pulmonary Embolism

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