Acute Effect of Continuous Positive Airway Pressure on Left Ventricular Diastolic Function and Exercise Tolerance in Compensated Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- improvement of isovolumetric relaxation time
研究概览
简要总结
Acute effects of CPAP on diastolic function in patients with compensated heart failure (CHF) are unknown. The investigators hypothesized that acutely CPAP improves diastolic function, which is associated with increases exercise tolerance.
Objective: To evaluate the acute effects of CPAP on functional capacity and diastolic indices of patients with CHF. This is a randomized trial including 44 patients with compensated heart failure (functional classes II or III, NYHA). Patients will be allocated in CPAP(CPAP with 10cmH2O) or simulated CPAP (null pressure) after computed randomization, in a 1:1 ratio. All subjects shall complete a 6-minute walk test (6MWT) before and after CPAP (30 minutes; 10 cm H2O pressure). Doppler-echocardiogram will be performed before and at the end of CPAP. Wilcoxon or paired t tests were used to compare results, with significance level at p < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •functional class II or III (NYHA)heart failure
- •agreement to participate in the study
- •absence of acute exacerbation of dyspnea
- •intact upper airway
排除标准
- •valvular heart disease
- •chest pain or unstable angina
- •acute myocardial infarction in the prior month
- •uncontrolled hypertension
- •atrial fibrillation or other arrhythmias
- •acute infection
- •orthopedic limitations
- •intolerance to CPAP mask
研究组 & 干预措施
positive airway pressure
干预措施: CPAP (Device)
结局指标
主要结局
improvement of isovolumetric relaxation time
时间窗: 30 minutes
Doppler-derived isovolumetric time will be measured before and after intervention (CPAP). A decreasing in isovolumetric time after CPAP will be interpretated as an improvement in myocardial relaxation
次要结局
- walk distance in the walk-test-six-minute (WT6M)(30 minutes)
研究者
Marjory Bussoni
mester
UPECLIN HC FM Botucatu Unesp