Summary

for people ages 45-75 (full criteria)
at San Diego, California
study started
estimated completion:
Jeremy E Orr

Description

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.

Official Title

Impact of Non-invasive Ventilation on Biomarkers in Hypercapnic COPD

Keywords

Copd Chronic Obstructive Pulmonary Disease Hypercapnia Chronic Respiratory Failure Hypoventilation lung non-invasive ventilation Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Insufficiency High-intensity non-invasive ventilation

Eligibility

You can join if…

Open to people ages 45-75

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

You CAN'T join if...

  • 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

Location

  • University of California San Diego accepting new patients
    San Diego California 92037 United States

Lead Scientist

  • Jeremy E Orr
    Clinical Instructor, Medicine. Authored (or co-authored) 15 research publications. Research interests: Control of breathing · Hypoxia · Chronic lung disease · Sleep apnea · Noninvasive ventilation

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03522805
Study Type
Interventional
Last Updated