Effects of Inpatient Initiation of Carvedilol and Nurse Management on Health Outcomes in Vulnerable Heart Failure Patients (ECHO Study): a Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Primary outcome: heart failure hospitalizations, time to death or hospitalization
研究概览
简要总结
The purpose of our study was to determine if a strategy of starting a heart medication (Beta-blocker) before patients leave the hospital and then being seen by a nurse manager would reduce subsequent hospitalizations compared to usual care.
Hypothesis: A nurse-directed heart failure management program with inpatient initiation of beta blockers will improve health outcomes in a vulnerable, predominantly Hispanic and African American population.
详细描述
Heart failure is a leading cause of death and hospitalization in the US. Designing practical approaches to improving heart failure care is therefore a national health priority. One retrospective study suggested that patients taking beta-blockers while hospitalized for heart failure had a lower risk of rehospitalization at 6-months. One prospective study suggested that starting beta blockers among hospitalized heart failure patients is safe and improves compliance. However, improved outcomes of this approach have not been prospectively demonstrated.
Comparison: Inpatient initiation of the beta-blocker carvedilol coupled with outpatient follow-up with a nurse manager was compared to usual care by internists and cardiologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary hospitalization with heart failure and LVEF < 40%
- •patient informed consent has been obtained
- •absence of pulmonary congestion
- •age > 18 years
排除标准
- •End-stage renal or hepatic disease
- •Acute myocardial infarction as primary diagnosis during index hospitalization
- •Life-expectancy < 6-months
- •Contraindication to beta blocker use
- •Current beta-blocker therapy
- •Planned bypass or valve surgery during index hospitalization
结局指标
主要结局
Primary outcome: heart failure hospitalizations, time to death or hospitalization
次要结局
- left ventricular ejection fraction and volume in systole and diastole
- beta-blocker utilization/adherence
- new york heart association functional class