Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Right Ventricular Hemodynamics Using Cardiac Magnetic Resonance Imaging in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA)
The coexistence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea
(OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S.
population.The investigators propose to conduct this study that aims: (1) to compare right
and left ventricular hemodynamic parameters using cardiac magnetic resonance imaging (MRI) in
overlap syndrome vs. COPD only and OSA only; (2) to compare the effects of bi-level positive
airway pressure (BPAP) vs. nocturnal oxygen therapy (NOT) on right ventricular (RV)
hemodynamics in overlap syndrome.
This study will allow us to test the hypothesis: (1) Patients with overlap syndrome have more
RV dysfunction than those with COPD only or OSA only; (2) treatment of both hypoxemia and
hypercapnia during sleep will improve RV hemodynamics compared with treatment of hypoxemia
alone in patients with overlap syndrome.
Despite the high prevalence of overlap syndrome, few data are available on its
pathophysiology and clinical consequences of these patients. Overlap syndrome has recently
been reported to have excess cardiovascular mortality compared with COPD alone. However, no
study has evaluated the mechanisms of excess cardiovascular mortality in untreated overlap
syndrome. In addition, no prospective, randomized, controlled data are currently available on
treatment of overlap syndrome.
This study is divided into two parts. The first part (Part 1) is a cross-sectional cohort
study comparing subjects with overlap syndrome to those with COPD alone and those with OSA
alone. Patients with COPD and OSA overlap syndrome will be evaluated by an overnight sleep
study, cardiac MRI, serum inflammatory biomarker, urine catecholamine level, pulmonary
function test, and questionnaires of sleep and health related quality of life. These
measurement will be compared between overlap syndrome and control groups with either COPD or
OSA alone.
The second part (Part 2) of the study is a prospective, parallel-group, randomized,
controlled pilot study examining the effect of BPAP (and nocturnal oxygen if needed) vs.
nocturnal oxygen therapy alone in patients with overlap syndrome (20 subjects in each
treatment arm). The same measurement done during Part 1 will be repeated to evaluate the
treatment effects.
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