Right Ventricular Hemodynamics Using Cardiac Magnetic Resonance Imaging in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Right Ventricular Remodeling Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both men and women with age more than 18 years.
- •Known diagnosis of stable COPD (GOLD stage 2 or higher) or OSA.
排除标准
- •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.
研究组 & 干预措施
Bi-level positive airway pressure (BPAP)
Bi-level positive airway pressure (BPAP)
干预措施: Bi-level positive airway pressure (BPAP) (Device)
Nocturnal oxygen
Nocturnal oxygen
干预措施: Nocturnal oxygen (Drug)
结局指标
主要结局
Right Ventricular Remodeling Index
时间窗: Six months
Defined as the ratio between RVMI and RV end-diastolic volume index using MRI
次要结局
- Right Ventricular End Systolic and Diastolic Volume(Six months)
- 6 Minute Walk Distance(6 months)
- Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)(6 months)
- General Health Status Through Short Form 36 (SF-36) Health Survey(6 months)
- Serum C-reactive Protein Level(6 months)
- Myocardial Extracellular Volume(Six months)
- Left Ventricular Remodeling Index(Six months)
- Right Ventricular Mass Index(Six months)
- Right Ventricular Ejection Fraction(Six months)
- Left Ventricular Mass Index(Six months)
- Left Ventricular End Systolic and Diastolic Volume(6 months)
- Left Ventricular Ejection Fraction(6 months)
- Serum Interleukin-6 Level(6 months)
- Serum Intercellular Adhesion Molecule-1(6 months)
- Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)(6 months)
- Serum Tumor Necrosis Factor-alpha Level(6 months)
- Serum P-selectin Level(6 months)
- Urine Catecholamine Level(6 months)
- Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)(6 months)
研究者
Robert L. Owens
Assistant Professor
University of California, San Diego