Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure

Summary

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.

Timeline

Start

2002-01

Primary completion

—

Completion

2006-10

Publications

• Background Tepel M, Giet MV, Park A, Zidek W. Association of calcium channel blockers and mortality in haemodialysis patients. Clin Sci (Lond). 2002 Nov;103(5):511-5. doi: 10.1042/cs1030511.
• Mugendi GA, Mutua FM, Natale P, Esterhuizen TM, Strippoli GF. Calcium channel blockers for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 Oct 1;10(10):CD011064. doi: 10.1002/14651858.CD011064.pub2.
• Tepel M, Hopfenmueller W, Scholze A, Maier A, Zidek W. Effect of amlodipine on cardiovascular events in hypertensive haemodialysis patients. Nephrol Dial Transplant. 2008 Nov;23(11):3605-12. doi: 10.1093/ndt/gfn304. Epub 2008 May 29.

Drugs

Indications