Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA

Not Applicable

Completed

Conditions: Chronic Obstructive Pulmonary Disease
Obstructive Sleep Apnea
Overlap Syndrome

Interventions: Device: Bi-level positive airway pressure (BPAP)
Drug: Nocturnal oxygen

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Already using continuous positive airway pressure (CPAP), BPAP device, or nocturnal oxygen.
Known or suspected renal failure with estimated Glomerular filtration (GFR) <50 ml/min/1.73 m2 or serum creatinine > 1.5 mg/dl.
Chronic atrial fibrillation or frequent premature ventricular contraction (> 10 beats per hour)
Women known to be pregnant or planning to be pregnant in next 6 months.
Known contraindication to MRI: cardiac pacemaker, metallic heart valves, metallic implants, history of claustrophobia.
If taking sildenafil or related drugs, unable to stop it within 48 hours of the study visit.
Uncontrolled COPD or acute COPD exacerbation.
Unstable cardiac diseases.
Known chronic inflammatory diseases like lupus or active infection.

Arm && Interventions

Group	Intervention	Description
Bi-level positive airway pressure (BPAP)	Bi-level positive airway pressure (BPAP)	Bi-level positive airway pressure (BPAP)
Nocturnal oxygen	Nocturnal oxygen	Nocturnal oxygen

Primary Outcome Measures

Name	Time	Method
Right Ventricular Remodeling Index	Six months	Defined as the ratio between RVMI and RV end-diastolic volume index using MRI

Secondary Outcome Measures

Name	Time	Method
Serum Interleukin-6 Level	6 months	blood test
Serum Intercellular Adhesion Molecule-1	6 months	blood test
Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)	6 months	Questionnaire
Right Ventricular End Systolic and Diastolic Volume	Six months	MRI
6 Minute Walk Distance	6 months	Low-grade physical activity test
Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)	6 months	Questionnaire
General Health Status Through Short Form 36 (SF-36) Health Survey	6 months	Questionnaire
Serum C-reactive Protein Level	6 months	blood test
Myocardial Extracellular Volume	Six months	MRI
Left Ventricular Remodeling Index	Six months	MRI
Right Ventricular Mass Index	Six months	MRI
Right Ventricular Ejection Fraction	Six months	MRI
Left Ventricular End Systolic and Diastolic Volume	6 months	MRI
Left Ventricular Ejection Fraction	6 months	MRI
Left Ventricular Mass Index	Six months	MRI
Serum Tumor Necrosis Factor-alpha Level	6 months	blood test
Serum P-selectin Level	6 months	Blood test
Urine Catecholamine Level	6 months	Urine test
Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)	6 months	Questionnaire