Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure (ADAM [Amlodipine and Dialysis Patients, Action on Mortality])
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- The primary outcome will be the survival rate. The secondary outcome will be cardiovascular events.
研究概览
简要总结
Patients with end-stage renal failure have a markedly higher mortality because of cardiovascular events in comparison with the normal population. Disorders in the calcium metabolism, such as calcification of the vessel walls, occur very frequently. There are indications that calcium channel blockers are capable of lowering the cardiovascular mortality in patients with end-stage renal failure.
It is intended to carry out a prospective, randomized, double-blind, placebo-controlled, multicenter study in order to find out if the calcium channel blocker amlodipine is able to reduce the mortality of patients with end-stage renal failure.
The investigation will be carried out after suitable explanation and written informed consent in 356 patients aged between 18 and 90 years with end-stage renal failure and chronic haemodialysis treatment. The patients will be randomized to either treatment with amlodipine 10 mg/day or placebo. The occurrence of events will be documented and evaluated prospectively over a period of 30 months.
详细描述
Trial protocol for ADAM Study
1.1 General Data:
- Title of the Study: Influence of Amlodipine on the Mortality of Patients with End-Stage Renal Failure (abbreviated title: ADAM [Amlodipine and Dialysis Patients, Action on Mortality])
- Study Directors:
Prof. Dr. med. Martin Tepel, Charite University of Berlin, Campus Benjamin Franklin, Medizinische Klinik IV, Hindenburgdamm 30, 12200 Berlin, Germany. Tel.: +49-30 8445 2305, Fax: +49-30 8445 4235, e-mail: Martin.Tepel@charite.de
Statistics:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage renal disease
- •Hemodialysis
- •Hypertension
- •Written informed consent
排除标准
- •Hypotension of less than 90 mmHg systolic
- •High-grade aortic stenosis
- •Heart failure of NYHA stage III and IV
- •Acute myocardial infarction (within the last 4 weeks)
- •Acute heart failure
- •Known allergy to the medicament amlodipine or other constituents of the medicament
- •Severe disorders of liver function
- •Pregnancy and breast-feeding
研究组 & 干预措施
1
Amlodipine
干预措施: Amlodipine (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The primary outcome will be the survival rate. The secondary outcome will be cardiovascular events.
时间窗: Prospective: look forward using periodic observations collected predominantly following subject enrollment
次要结局
未报告次要终点