Inhaled Nitric Oxide in Pulmonary Embolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to determine if inhaled nitric oxide, a potent and selective pulmonary vasodilator, is beneficial in patients with acute pulmonary embolism causing increased right ventricular afterload.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients

NCT00782652

Right Ventricular Infarction

TERMINATED PHASE2

Phase I Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism

NCT00848731

Pulmonary Embolism

COMPLETED PHASE1

Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing

NCT00626028

Idiopathic Pulmonary Arterial Hypertension Cardiomyopathy

COMPLETED PHASE3

Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest

NCT03079102

Heart Arrest, Out-Of-Hospital

TERMINATED PHASE2

Inhaled Nitrite in Subjects With Pulmonary Hypertension

NCT01431313

Pulmonary Hypertension Heart Failure, Diastolic

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The early phase of severe pulmonary embolism is associated with high mortality. Right ventricular failure induced by the increase in right ventricular afterload is the final cause of deterioration leading to circulatory failure in patients who die from severe pulmonary embolism. Therefore, reduction of right ventricular afterload remains the central therapeutic strategy. In acute pulmonary embolism, the increase in pulmonary vascular resistance is caused by reduction in the cross-sectional area of the pulmonary vascular bed from obstructing emboli. Pulmonary arterial constriction further increases pulmonary vascular resistance, whereby vasoactive humoral factors may be contributing, which are released from activated platelets accumulating at the site of the clot. Consequently, administration of vasodilators of the pulmonary circulation may be regarded as a therapeutic option to antagonize increased pulmonary vasoconstriction or compensate for impaired vasodilation. Inhaled nitric oxide (NO) acts as a powerful selective pulmonary vasodilator. The aim of the study is to determine, if short-term inhalation of NO is beneficial in respiratory compromised patients with right ventricular dysfunction after acute pulmonary embolism.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Embolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inhaled nitric oxide (NO)

20 ppm for 15 minutes

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with acute pulmonary embolism within 24 hours after onset of symptoms.
* Patients with hypoxaemia not present before pulmonary embolism and acute right ventricular dysfunction.

Exclusion Criteria

* Age \< 18 years.
* Chronic lung disease, left heart failure, suspected or documented intracranial bleeding.
* Pregnancy, Methaemoglobinaemia.
* Patients who previously needed thrombolysis or surgical embolectomy.
* Negative D-Dimer test.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No