Effect of Heart Valve Replacement on Cheyne-Stokes Respiration in Patients With Rheumatic Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Changes of CSR index before and 3, 6, 12 months following valve replacement.
研究概览
简要总结
Sleep disordered breathing, especially central sleep apnea, is common in patients with chronic heart failure. Heart valve replacement could have some effect on central sleep apnea. The aim of the study is to investigate effect of heart valve replacement on Cheyne-Stokes respiration in patients with rheumatic heart disease.
详细描述
Sleep apnea, especially central sleep apnea, has a high prevalence in patients with chronic heart failure. Although sleep disordered breathing (SDB) have been described in patients with heart disease, the prevalence is not known because: ①There are various forms of SDBs, including obstructive sleep apnea(OSA), central sleep apnea (CSA), and mixed forms of sleep apnea syndromes that have variable prevalence; ②Patients suffering from rheumatic valve disease usually have varying degrees of heart failure, and this variability affects estimates of prevalence; ③There are no international patient registries and SDB is underdiagnosed in many parts of the world.
The previous studies are most focusing on nonvalvular disease. We ①investigate the prevalence and the risk factors of Cheyne-Stokes respiration in patients with heart valve diseases, ②compare the changes of parameters of Cheyne-Stokes Respiration and heart function (like apnea hypopnea index, pulse oxygen saturation, blood pressure, echocardiogram, electrocardiogram, 6-minute walk test) before heart valve replacement and 3, 6, and 12 months after the surgery.
With nocturnal polysomnography (PSG) examination 30 patients typical CSR are going to be screened out from 300 patients with heart valve disease and waiting for cardiac surgery. The Comparison of 30 patients undergoing heart valve replacement will be performed before and 3, 6, and 12 months following heart valve replacement. We shall analyze the changes of CSR before and after valve replacement as well as the correlation among cardiac function and PSG parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heart valve disease with any ejection fraction
- •clinical diagnosis of Cheyne-Stokes respiration
排除标准
- •unstable heart failure
- •transient ischemic attack in last 6 months
- •pacemaker, cardioverter-defibrillator or resynchronization device implanted less than 6 months before study entrance
- •severe chronic obstructive pulmonary disease
结局指标
主要结局
Changes of CSR index before and 3, 6, 12 months following valve replacement.
时间窗: 1 year after cardiac surgery of each enrolled patient
The primary goal of this study is to compare the changes of polysomnography(PSG) parameters(index of CSR, apnea hypopnea index, pulse oxygen saturation, etc)before and 3, 6, 12 months following the cardiac valve replacement surgery.
次要结局
- Association of PSG parameters with cardiac function before and 3, 6, 12 months following valve replacement(1 year after cardiac surgery of each enrolled patient)
研究者
Zhang Xilong
Department of Respirology, The First Affiliated Hospital of Nanjing Medical University
Nanjing Medical University
