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临床试验/NCT00804349
NCT00804349已完成4 期

Apnea Rampant In Acute Decompensated Heart Failure II

Albert Einstein Healthcare Network2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
6
试验地点
2
主要终点
Reduction in Episodic Oxygen Desaturation

研究概览

简要总结

Heart Failure affects 5-6 million Americans and there are about 550 thousand new cases of heart failure every year. There are approximately 3 million hospital admission for acute decompensated heart failure with hospital readmission rate of 20% at 30 days and 50% at 60 day, costing up to 20 billion dollars per year. In our previous study we have discovered that sleep disordered breathing is prevalent in 70% of patients with acute decompensated heart failure. We hypothesize that, detection and treatment of sleep disordered breathing in acute decompensated heart failure patients will reduce episodic hypoxic events during acute decompensation and may decrease hospital length of stay and reduce future readmissions.

详细描述

Background:

Heart failure (HF) affects 5 to 6 million Americans and is increasing in prevalence. There are about 550,000 new cases of heart failure every year and about 3 million admissions for acute decompensated heart failure every year. Despite advances in medical care, the hospital readmission rate is 20% at one month and 50% at six months. The total cost of heart failure on the health system is upwards of 35 billion dollars per year. About half of these resources are used during acute hospitalizations.

An important limitation to the current approach to the management of HF is the focus on the awake patient. This approach underestimates the mechanisms that might contribute to the pathophysiology or progression of HF.

Sleep disordered breathing (SDB) is very common in congestive heart failure. Recently, the adverse implications of SDB in patients with HF have been appreciated. Intermittent apnea-induced hypoxia, hypercapnia, surges in central sympathetic outflow and left ventricular afterload, daytime hypertension, and loss of vagal heart rate regulation are potent stimuli to myocyte necrosis and apoptosis, myocardial ischemia, arrhythmias, adverse cardiac remodeling, and the resulting accelerated disease progression in HF.

This makes us believe that treatment of SDB during acute decompensated heart failure in addition to standard medical therapy (SMT) would be beneficial.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over the age of 18 and able to consent
  • NYHA Class III/IV Symptoms
  • Objective Evidence of Heart Failure
  • Physical Exam consistent with Heart Failure
  • BNP greater than 500
  • Radiographic Evidence of Heart Failure
  • SDB (AHI > 5/hour) on Nexan CPS
  • Ability to tolerate appropriate medical therapy for Heart Failure
  • Willingness to follow-up as an outpatient after discharge

排除标准

  • Patients with known Sleep-Disordered Breathing currently using CPAP or BiPAP
  • Patients with known COPD
  • Patients with known restrictive lung disease
  • Patients with tracheostomy in place
  • Acute MI/Acute Coronary Syndrome at time of hospitalization
  • Cardiogenic Shock
  • Troponin Leak greater than 0.08
  • Patients with major multisystem disorders
  • Expected survival less than 6 months
  • End Stage Renal Disease on Dialysis
  • Chronic Liver Disease
  • Albumin level less than
  • Patients from Nursing homes

结局指标

主要结局

Reduction in Episodic Oxygen Desaturation

时间窗: Concurrent

0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

次要结局

  • Length of Stay(Concurrent)
  • Visual Analog Scale of Shortness of Breath(Concurrent)
  • Readmission(30 days post discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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