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Nitric Oxide to Treat Pulmonary Embolism

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ClinicalTrials.gov Identifier: NCT01939301
Recruitment Status : Active, not recruiting
First Posted : September 11, 2013
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
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)
Information provided by (Responsible Party):
Jeffrey Kline, Indiana University School of Medicine

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

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: Inhaled Nitric Oxide Drug: Sham Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
Study Start Date : October 2013
Actual Primary Completion Date : October 31, 2016
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Inhaled Nitric Oxide
Inhaled nitric oxide
Drug: Inhaled Nitric Oxide
Nitric Oxide + oxygen
Placebo Comparator: Placebo
Oxygen
Drug: Sham
Nitrogen + Oxygen
Other Names:
  • placebo
  • oxygen



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939301


Locations
United States, Indiana
Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Methodist Hospital
Indianapolis, Indiana, United States, 46202
United States, Mississippi
University of Mississippi
Jackson, Mississippi, United States, 36216
Sponsors and Collaborators
Indiana University School of Medicine
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)
Investigators
Principal Investigator: Jeff A Kline, MD Indiana University

Responsible Party: Jeffrey Kline, Vice Chair of Research, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT01939301     History of Changes
Other Study ID Numbers: Kline-1UM NO for PE
1UM1HL113203-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2013    Key Record Dates
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by Jeffrey Kline, Indiana University School of Medicine:
Pulmonary embolism clot

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents