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NCT03522805 · ClinicalTrials.gov registry record · NA

Impact of Non-invasive Ventilation in Hypercapnic COPD

A NA study, sponsored by University of California, San Diego.

Terminated
Registry status
NA
Development phase
6
Enrollment target

NCT03522805 is a NA study that was terminated before completion, run by University of California, San Diego. The registered enrollment target is 6 participants.

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The verdict

NCT03522805, a NA study, was terminated before completion, sponsored by University of California, San Diego.

TERMINATED
Registry status
NA
Development phase
6 participants
Enrollment target

Study Summary

Chronic obstructive pulmonary disease (COPD) is a highly prevalent condition worldwide and is a cause of substantial morbidity and mortality. Unfortunately, few therapies have been shown to improve survival. The importance of systemic effects and co-morbidities in COPD has garnered attention based on the observation that many patients with COPD die from causes other than respiratory failure, including a large proportion from cardiovascular causes. Recently, two high profile randomized trials have shown substantial improvements in morbidity and mortality with use of nocturnal non-invasive ventilation (NIV) in COPD patients with hypercapnia. Although the mechanisms by which NIV improves outcomes remain unclear, the important benefits of NIV might be cardiovascular via a number of mechanisms. In contrast to prior trials of NIV in COPD that did not show substantial benefit, a distinguishing feature of these encouraging recent NIV clinical trials was a prominent reduction of hypercapnia, which might be a maker or mediator of effective therapy. Alternatively, improvements might be best achieved by targeting a different physiological measure. Additional mechanistic data are therefore needed to inform future trials and achieve maximal benefit of NIV. Recent work in cardiovascular biomarkers has identified high-sensitivity troponin to have substantial ability to determine cardiovascular stress in a variety of conditions - even with only small changes. In COPD, a number of observational studies have shown that high-sensitivity troponin increases with worsening disease severity, and that levels increase overnight during sleep. This biomarker therefore presents a promising means to study causal pathways regarding the effect of NIV in patients with COPD. With this background, the investigator's overall goals are: 1) To determine whether the beneficial effect of non-invasive ventilation might be due to a reduction in cardiovascular stress, using established cardiovascular biomark

Interventions

  • DEVICE High-intensity non-invasive ventilation

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2018-04-23
Est. Completion 2018-11-21
Phase NA

Sponsor

University of California, San Diego

775 total trials

What the Registry Record Tells You About NCT03522805

The ClinicalTrials.gov registry entry for NCT03522805 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which High-intensity non-invasive ventilation is the first listed.

NCT03522805 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03522805 about?

NCT03522805 is a clinical study titled "Impact of Non-invasive Ventilation in Hypercapnic COPD". Chronic obstructive pulmonary disease (COPD) is a highly prevalent condition worldwide and is a cause of substantial morbidity and mortality. Unfortunately, few therapies have been shown to improve survival. The importance of systemic effects and co-morbidities in COPD has garnered attention based o...

What is the current status of trial NCT03522805?

This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2018-04-23. Estimated completion is 2018-11-21.

What interventions are being tested in trial NCT03522805?

The interventions under investigation include: High-intensity non-invasive ventilation (DEVICE).

Who is sponsoring clinical trial NCT03522805?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.