The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
Status:
Not yet recruiting
Trial end date:
2027-08-31
Target enrollment:
Participant gender:
Summary
Aim 1: We will perform a cross-sectional study to examine vascular risk in individuals with
OVS compared with matched individuals with OSA alone or COPD alone. We will examine a panel
of biomarkers including cardiac magnetic resonance imaging (right ventricular mass primary
outcome), flow mediated vasodilation, plasma biomarkers (BNP, troponin, hsCRP, ST2,
galectin3, miR-210). This aim will allow us to test the hypothesis that individuals with OVS
have increased vascular risk compared with matched individuals with OSA alone or COPD alone.
This aim will also allow us to compare the magnitude of the effect of OSA vs. COPD vs OVS for
design of subsequent basic and clinical studies.
Aim 2: We will perform an interventional study in individuals with OVS to compare the impact
of bi-level therapy with that of oxygen therapy (the current standard of care). We will
assess the same panel of biomarkers as in Aim 1 to determine the impact of treatment on the
observed abnormalities. This aim will allow us to test the hypothesis that bi-level therapy
is superior to oxygen in the treatment of individuals with OVS from the standpoint of right
ventricular mass and other cardiovascular risk parameters/outcomes. Our assessments of
biomarkers will help to define potential causal pathways for our findings and will allow
determination of appropriate biomarkers for subsequent multicenter studies.