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Nitric Oxide to Treat Pulmonary Embolism

I

Indiana University School of Medicine

Status and phase

Completed
Phase 2

Conditions

Pulmonary Embolism

Treatments

Drug: Sham
Drug: Inhaled Nitric Oxide

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT01939301
1UM1HL113203-01A1 (U.S. NIH Grant/Contract)
Kline-1UM NO for PE

Details and patient eligibility

About

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

Full 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.

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

78 participants in 2 patient groups, including a placebo group

Inhaled Nitric Oxide
Active Comparator group
Description:
Inhaled nitric oxide
Treatment:
Drug: Inhaled Nitric Oxide
Placebo
Placebo Comparator group
Description:
Oxygen
Treatment:
Drug: Sham

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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