Cluster and Registry Trials Of the Working Group of Heart Failure in Denmark: Are SPironolactone and Eplerenone Comparable Treatments?
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 7,200
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Objective The objective is to compare the efficacy of spironolactone and eplerenone on clinical outcome in patients with heart failure and a reduced ejection fraction.
Method The study is a crossover cluster randomized trial. Each heart failure clinic in Denmark will be allocated to four periods (clusters): two periods with spironolactone and two periods with eplerenone as first drug. The planned total participation time for each department is 4 years and we estimate that data from 7200 patients will be accrued in this period. Endpoints will be assessed through Danish National Registries.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients registered in the Danish Heart Failure Registry who has a baseline left ventricular ejection fraction <40% and who has filled in a prescription for an aldosterone antagonist
排除标准
- •patients who had filled in a prescription for an aldosterone antagonist prior ro registration in the Danish Heart Failure Registry
研究组 & 干预措施
Spironolactone
Spironolactone used according to heart failure guidelines
干预措施: Spironolactone (Drug)
Eplerenone
Eplerenone used according to heart failure guidelines
干预措施: Eplerenone (Drug)
结局指标
主要结局
Mortality
时间窗: 5 years
Mortality (will be used if overall mortality rate is 15% or greater)
Mortality or hospitalization for heart failure
时间窗: 6 years
Will be used if overall mortality is less than 15%
次要结局
未报告次要终点
研究者
Jens Jakob Thune
Clinical research associate professor
Bispebjerg Hospital