Collaborative Systematic Overview of Randomised Controlled Trials of Beta-Blockers in the Treatment of Heart Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 18,240
- 试验地点
- 2
- 主要终点
- Beta-blocker therapy improves overall mortality and morbidity in symptomatic heart failure in an individual patient meta-analysis
研究概览
简要总结
Several large trials have shown that beta-blocker treatment reduces the risk of death and hospital admission in patients with symptomatic heart failure. Unfortunately, survey data suggests relatively poor utilisation of beta-blockers, despite ample evidence for good tolerability. Additionally there are several important unanswered questions, such as clinical efficacy for specific sub-populations (women, the elderly and patients with diabetes or other co-morbidities) and the effect of beta-blockers in combination with other medications. Previous meta-analyses, based on published tabular data, have been conducted although this approach has important biases and limitations.
We plan to perform a carefully conducted systematic review of individual patient data from the major randomised trials of beta-blockers in heart failure. The goals of this collaborative project are to clarify the overall efficacy of beta-blockers and identify sub-groups that show particular benefit, thereby increasing the use of beta-blockers, reducing adverse clinical outcomes and the high costs associated with this condition.
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Randomised control trials of beta-blocker versus control in patients with documented heart failure
- •Unconfounded trials only (in which one treatment group differed from another only by the beta-blocker therapy of interest)
- •Randomization process precluded prior knowledge of the next treatment (for example trials in which treatment allocation was alternate or based on odd or even dates would not be included)
排除标准
- •Trial sample size of less than 300 patients
研究组 & 干预措施
Beta blocker
干预措施: Beta blocker (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Beta-blocker therapy improves overall mortality and morbidity in symptomatic heart failure in an individual patient meta-analysis
时间窗: variable (time to event)
次要结局
- Beta-blocker therapy improves mortality and morbidity in both elderly patients and women(variable (time to event))
- Beta-blocker therapy improves mortality and morbidity in patients with co-morbidities (diabetes, renal dysfunction, COPD, peripheral arterial disease or atrial fibrillation)(variable (time to event))
- The benefit of beta-blockers is not modified by concomitant cardiovascular therapy(variable (time to event))
- The benefit of beta-blockers is independent of left ventricular ejection fraction at baseline(variable (time to event))
- The clinical benefit is dependent on the resting heart rate achieved whatever the dose achieved or agent used(variable (time to event))
- Adverse side effects of beta blocker therapy do not significantly impact on clinical benefit (as a whole and in relevant sub-groups)(variable (time to event))