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临床试验/NCT00701038
NCT00701038已完成不适用

The Role of Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure

Rami Khayat0 个研究点目标入组 54 人开始时间: 2006年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
主要终点
Left Ventricular Ejection Fraction Improvement

研究概览

简要总结

Congestive heart failure affects 2.3 percent of the population (approximately 4,900,000) with an incidence of 10 per 1,000 of the population after the age of 65 (1). The admission rate for patients with heart failure is on the rise, so is the mortality associated with it and its national annual bill, now exceeding $21 billion (1). Obstructive Sleep Apnea (OSA) is present in 11-37 percent of patients with heart failure (2,3), and tends to increase in severity when the heart failure is less controlled (4, 5). Therefore, the actual prevalence of OSA in patients hospitalized with acute heart failure is likely higher. There is now evidence that treatment of OSA with nasal Continuous Positive Pressure (nCPAP) in outpatients with stable heart failure improves left ventricular ejection fraction, and quality of life (6), and confers a reduction in fatal and non-fatal cardiovascular events (7). However, there has not been any evaluation of the role of diagnosis and treatment of OSA in patients hospitalized with acute heart failure. This uncertainty about the true prevalence and role of OSA in exacerbations of heart failure, and the role of its treatment in the acute setting may explain why aggressive diagnostic and therapeutic strategy for OSA in patients admitted to the hospital with acute heart failure is not part of the standard clinical practice in acute care centers. Given the rising admission rate, and mortality associated with heart failure, an evaluation of the role of OSA and its treatment in this patient population is highly significant.

详细描述

OSA is associated with large negative swings in the intrathoracic pressure, significant increase in the sympathetic nerve activity and repetitive surges in blood pressure, along with episodic hypoxia and hypercapnea (8, 9). These autonomic and respiratory changes may increase the cardiac muscle workload, cardiac dysrrhythmia, and exacerbate ischemia (10,11,12). Treatment with continuous positive airway pressure (CPAP) is the most successful therapeutic modality available for obstructive sleep apnea. It is still not clear whether establishing the diagnosis of OSA and initiating treatment with CPAP while still in the hospital carries any benefit in the management of patients with acute heart failure. This study will evaluate the effect of work up and treatment of OSA on the outcome of patients hospitalized with acute congestive heart failure (CHF).

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
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to provide an informed consent
  • Speaks English
  • Older than 21
  • Heart Failure
  • Positive for OSA

排除标准

  • Already on CPAP
  • Hemodynamic instability
  • Acute respiratory failure
  • Neurological defect

结局指标

主要结局

Left Ventricular Ejection Fraction Improvement

时间窗: baseline and again after three nights in hospital

Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.

次要结局

未报告次要终点

研究者

发起方
Rami Khayat
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rami Khayat

Associate Professor-Clinical

Ohio State University

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