Prevalence and Dynamics of Sleep-Disordered Breathing (SDB) in Patients With Severe Valvular Regurgitation and High Surgical Risk Undergoing Minimally Invasive Clip Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Influence of the minimal invasive Clip technique on apnea-hypopnea index
研究概览
简要总结
In a prospective observational study, the investigators investigate the prevalence of sleep disordered breathing in patients with severe valvular regurgitation and the effect of using the minimal invasive Clip technique on sleep disordered breathing.
详细描述
The purpose of this study is to analyze the prevalance of sleep disordered breathing in patients with severe valvular regurgitation and the impact of a therapy with the minimal-invasive Clip technique.
Therefore, the investigators want to include consecutive patients with unknown sleep-associated respiratory distress syndrome and, in addition, as a study-specific achievement, the investigators want to obtain the quality of life and specific symptoms of the patients by using established questionnaires. After three month of post-interventional care, the patients will get a post-interventional check-up in our cardiological outpatient clinic, where the course of sleep-associated respiratory distress syndrome and the actual quality of life and specific symptoms will be documented by using a cardiorespiratory polygraphy and the same questionnaires.
The entire hospital stay, including possible post-interventional complications, will be documented for this study from the patients' medical records. The routine examinations (laboratory values, ECG, 6-minute walk test, pulmonary function examinations, spiroergometry, transthoracic / -oesophageal echocardiography, etc.) shall also be recorded in the database of this study.
The plan is to include 100 evaluable patients with complete follow-up and the associated test results. For this purpose, a screening of 150 patients is expected to be required.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe valvular regurgitation and currently unknown sleep disorder breathing who will be treated with a minimal invasive Clip technique
排除标准
- •Patients with more then one valvular disease which requires Treatment
- •Patients with complex congenital heart disease
- •Pregnant women
结局指标
主要结局
Influence of the minimal invasive Clip technique on apnea-hypopnea index
时间窗: 3 month
Changes on the number of apnea and hypopnea events per hour of sleep due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on apnea index
时间窗: 3 month
Changes on the number of apnea events per hour of sleep due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on ventilation length during sleep
时间窗: 3 month
Changes on the ventilation length (in seconds) due to the minimal invasiv Clip technique
Prevalance of Sleep disordered breathing in Patiens with severe valvular regurgitation
时间窗: 3 month
Proportion of of Sleep disordered breathing in Patiens with severe valvular regurgitation in a given time period
Influence of the minimal invasive Clip technique on T90
时间窗: 3 month
Changes on the the percentage of time during which arterial O2 saturation was less than 90% (T90) due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on PISA in tranthoracic echocardiography
时间窗: 3 month
Changes on the proximal isovelocity hemispheric surface area (PISA in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on the effective regurgitant orifice (ERO) in tranthoracic echocardiography
时间窗: 3 month
Changes on the effective regurgitant orifice (ERO in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on the peak velocity of the mitral regurgitant jet (mR-Vmax) in tranthoracic echocardiography
时间窗: 3 month
Changes on the peak velocity of the mitral regurgitant jet (mR-Vmax in meter per seconds) in tranthoracic echocardiography due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on the myocardial perfomance index (TEI-index) in tranthoracic echocardiography
时间窗: 3 month
Changes on systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function (without unity) in tranthoracic echocardiography due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on the oxygen desaturation index
时间窗: 3 month
Changes on the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on sleep cycle length
时间窗: 3 month
Changes on the duration of the five stages of sleep (in minutes) due to the minimal invasiv Clip technique
次要结局
- Post-interventional assessment of the sleep quality with and without sleep disordered breathing(3 month)
- Post-interventional survey of patient health with and without sleep disordered breathing(3 month)
- Post-interventional changes in generic health status. with and without sleep disordered breathing(3 month)
- Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure(3 month)
- Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing(3 month)
- Post-interventional changes aerobic capacity and endurance with and without sleep disordered breathing(3 month)
- Post-interventional changes functional capacity of cardiopulmonary and musculoskeletal system with and without sleep disordered breathing(3 month)
- Post-interventional changes in daytime sleepiness with and without sleep disordered breathing(3 month)
- Post-interventional changes on cognitive functions with and without sleep disordered breathing(3 month)
研究者
Muhammed Gerçek
Principal Investigator
Heart and Diabetes Center North-Rhine Westfalia