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Impact of Non-invasive Ventilation in Hypercapnic COPD

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ClinicalTrials.gov Identifier: NCT03522805
Recruitment Status : Terminated (Failure to accrue subjects. All activity has stopped & no analysis will be done on what has been collected.)
First Posted : May 11, 2018
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Jeremy Orr, M.D., University of California, San Diego

Brief 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 biomarkers, and 2) To define whether a reduction in PaCO2 (or alternative mechanism) is associated with such an effect.

Condition or disease Intervention/treatment Phase
Copd Chronic Obstructive Pulmonary Disease Hypercapnia Chronic Respiratory Failure Hypoventilation Device: High-intensity non-invasive ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Non-invasive Ventilation on Biomarkers in Hypercapnic COPD
Actual Study Start Date : April 23, 2018
Actual Primary Completion Date : November 21, 2018
Actual Study Completion Date : November 21, 2018

Arm Intervention/treatment
Experimental: Non-invasive ventilation
Subjects will undergo a baseline night with standard polysomnography, followed by a treatment night using non-invasive ventilation under polysomnography
Device: High-intensity non-invasive ventilation
Single night of high-intensity non-invasive ventilation




Primary Outcome Measures :
  1. Paired difference in morning level of high sensitivity troponin between baseline and NIV nights [ Time Frame: 1 day ]
    Comparing morning levels of high sensitivity troponin between baseline and NIV nights


Secondary Outcome Measures :
  1. Paired difference in overnight increase in high sensitivity troponin between baseline and NIV night [ Time Frame: 1 day ]
    Troponin assay: Minimum 0, no maximum, with higher values worse.

  2. Paired difference in sleep quality by Richards-Campbell Sleep Questionnaire between baseline and NIV night [ Time Frame: 1 day ]
    Questionnaire: 5 questions, 0 to 100 on visual analog scale, with higher scores indicating better sleep. Total score reported as mean of 5 components.

  3. Paired difference in sleep quality by arousal index between baseline and NIV night [ Time Frame: 1 day ]
    Arousal index: Index reported as events/hour. Minimum 0, no maximum, with higher scores indicating worse sleep.

  4. Paired difference in heart rate variability during sleep between baseline and NIV night [ Time Frame: 1 day ]
    Comparing difference in heart rate variability during sleep between baseline and NIV night

  5. Paired difference between Morning psychomotor vigilance testing score between baseline and NIV night [ Time Frame: 1 day ]
    Psychomotor vigilance score: Reported as number of lapses. Minimum 0, no maximum, with higher values worse.

  6. Paired difference in morning exhaled nitric oxide level between baseline and NIV night [ Time Frame: 1 day ]
    Exhaled nitric oxide assay: Minimum 0, no maximumm with higher values worse.



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with previously diagnosed severe COPD (FEV1 <50% predicted) and daytime hypercapnia (PaCO2 or TcCO2 > 45 mmHg)

Exclusion Criteria:

  • Lung disease besides COPD (e.g., pulmonary fibrosis, bronchiectasis, pulmonary arterial hypertension) other than well controlled asthma
  • Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
  • Uncontrolled hypertension (SBP >160, DBP >95)
  • Unwilling or unable to withhold CPAP during polysomnography
  • Presence of tracheostomy
  • Hospitalization within the past 90 days
  • Prior peptic ulcer disease, esophageal varicies, or gastrointestinal bleeding (< 5 years)
  • Prior gastric bypass surgery
  • Anticoagulant use (other than aspirin) or bleeding diathesis (only for esophageal catheter placement)
  • Chronic liver disease or end-stage kidney disease
  • Allergy to any of the study medications
  • Regular use of medications known to affect control of breathing (opioids, benzodiazepines, theophylline)
  • Insomnia or circadian rhythm disorder
  • Active illicit substance use or >3 oz nightly alcohol use
  • Psychiatric disease, other than controlled depression
  • Pregnancy
  • Prisoners
  • Cognitive impairment, unable to provide consent, or unable to carry out research procedures

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): NCT03522805


Locations
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United States, California
University of California San Diego
San Diego, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Jeremy E Orr, MD UCSD
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Responsible Party: Jeremy Orr, M.D., Assistant Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03522805    
Other Study ID Numbers: 161873
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeremy Orr, M.D., University of California, San Diego:
copd
lung
non-invasive ventilation
hypercapnia
hypoventilation
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Hypoventilation
Hypercapnia
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory