Clinical trial NCT02244957: Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA
Official title: Right Ventricular Hemodynamics Using Cardiac Magnetic Resonance Imaging in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Chronic Obstructive Pulmonary Disease
Overlap Syndrome
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Both men and women with age more than 18 years.
* Known diagnosis of stable COPD (GOLD stage 2 or higher) or OSA.

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.

Primary outcomes:
measure: Right Ventricular Remodeling Index
timeFrame: Six months
Secondary outcomes:
measure: Right Ventricular Mass Index
timeFrame: Six months
measure: Right Ventricular End Systolic and Diastolic Volume
timeFrame: Six months
measure: Right Ventricular Ejection Fraction
timeFrame: Six months
measure: Myocardial Extracellular Volume
timeFrame: Six months
measure: Left Ventricular Remodeling Index
timeFrame: Six months
measure: Left Ventricular Mass Index
timeFrame: Six months
measure: Left Ventricular End Systolic and Diastolic Volume
timeFrame: 6 months
measure: Left Ventricular Ejection Fraction
timeFrame: 6 months
measure: Serum C-reactive Protein Level
timeFrame: 6 months
measure: Serum Tumor Necrosis Factor-alpha Level
timeFrame: 6 months
measure: Serum Interleukin-6 Level
timeFrame: 6 months
measure: Serum Intercellular Adhesion Molecule-1
timeFrame: 6 months
measure: Serum P-selectin Level
timeFrame: 6 months
measure: Urine Catecholamine Level
timeFrame: 6 months
measure: 6 Minute Walk Distance
timeFrame: 6 months
measure: Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 6 months
measure: Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)
timeFrame: 6 months
measure: Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 months
measure: General Health Status Through Short Form 36 (SF-36) Health Survey
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UCSD
name: Robert L Owens, MD
role: PRINCIPAL_INVESTIGATOR
References: