Pulmonary EmbolismPhase 2NCT01939301
Nitric Oxide to Treat Pulmonary Embolism
A Phase 2 study testing Inhaled Nitric Oxide in people with Pulmonary Embolism, run by Indiana University at 4 sites in United States.
Trial summary
This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Inhaled Nitric Oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2013to 31 Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Eskenazi Hospital
Indianapolis, Indiana, 46202
Indiana University Hospital
Indianapolis, Indiana, 46202
Methodist Hospital
Indianapolis, Indiana, 46202
University of Mississippi
Jackson, Mississippi, 36216
About this study
Official title: Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).
Read the 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.
- Conditions
- Pulmonary Embolism
- Being tested
- Inhaled Nitric Oxide, Sham
- Keywords
- Pulmonary embolism clot
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Nitric OxideDrug
Nitric Oxide + oxygen
ShamDrug
Also called placebo, oxygen
Nitrogen + Oxygen
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide | Active comparator | Inhaled nitric oxide Receives: Drug: Inhaled Nitric Oxide |
| Placebo | Placebo comparator | Oxygen Receives: Drug: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days or hospital discharge (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startOct 2013
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Principal investigator, Jeffrey Kline, Indiana University
- Investigators
- Jeff A Kline, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939301
- Sponsor's protocol ID
- Kline-1UM NO for PE
- Other IDs
- 1UM1HL113203-01A1
- Status last verified
- Sep 2018
- First submitted
- 28 Aug 2013
- Last updated
- 3 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30633959Kline 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.
PubMed 28454823
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT01939301
- Acronym / sponsor ID
- Kline-1UM NO for PE
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism clot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- 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)
- Study start
- Oct 2013
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Posted 29 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitric Oxide | Active comparator | Drug: Inhaled Nitric OxideInhaled nitric oxide |
| Placebo | Placebo comparator | Drug: ShamOxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled Nitric OxideNitric Oxide + oxygen | Drug | Inhaled Nitric Oxide |
| ShamAlso: placebo, oxygenNitrogen + Oxygen | Drug | Placebo |
Primary outcome
Number of Participants With Normal Right Ventricular (RV) Function and Viability
Time frame: 5 days or hospital discharge (whichever occurs first)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30633959Kline 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.
- Derived from this study: PubMed 28454823Kline 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff A Kline, MD principal investigator
Indiana University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled Nitric Oxide in people with Pulmonary Embolism, run by Indiana University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Normal Right Ventricular (RV) Function and Viability (time frame: 5 days or hospital discharge (whichever occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01939301, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.