Prevention of sudden cardiac death: rationale and design of the Implantable Cardioverter Defibrillators in Dialysis patients (ICD2) Trial--a prospective pilot study.
OBJECTIVE
Sudden cardiac (arrhythmic) death (SCD) is the single largest cause of death in dialysis patients. Prophylactic Implantable Cardioverter Defibrillator (ICD) therapy reduces SCD and reduces all-cause mortality in several groups of patients at high risk for arrhythmic death. Whether this also applies to dialysis patients is unknown.


METHODS
The Implantable Cardioverter Defibrillator in Dialysis patients (ICD2) trial is a prospective randomised controlled study. It has been designed to evaluate the efficacy and safety of prophylactic ICD therapy in reducing sudden cardiac death rates in dialysis patients aged 55-80 years. A total of 200 patients will be included. The primary endpoint of the study is sudden cardiac (arrhythmic) death. The mean follow-up time will be 4 years.


BACKGROUND
'The Netherlands Trial Register'--ISRCTN20479861


CONCLUSIONS
The ICD2 trial--a pilot study--will be the first study to evaluate the possible benefit of ICD therapy for the primary prevention of sudden cardiac death in dialysis patients.
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Mihaly K
MK
de Bie
Jaco C
JC
Lekkerkerker
Bastiaan
B
van Dam
Andre
A
Gaasbeek
Marjolijn
M
van Buren
Hein
H
Putter
Lieselot
L
van Erven
Jeroen J
JJ
Bax
Martin J
MJ
Schalij
Ton J
TJ
Rabelink
J Wouter
JW
Jukema
D000368:Aged; D000369:Aged, 80 and over; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D004867:Equipment Design; D006801:Humans; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D006435:Renal Dialysis; D018401:Sample Size