Prevention of sudden cardiac death: rationale and design of the Implantable Cardioverter Defibrillators in Dialysis patients (ICD2) Trial – a prospective pilot study

ABSTRACT

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.

Research design and 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.

Trial registration: ‘The Netherlands Trial Register’ – ISRCTN20479861

Conclusion: 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.

Key words: :

• Coronary calcifications
• Dialysis
• Implantable cardioverter device therapy
• Risk factors
• Sudden cardiac death
• Ventricular arrhythmias

Acknowledgements

Declaration of interest: The ICD2 study and the publication of this article were supported by an unrestricted educational research grant from Biotronik GmbH & Co. KG. There is no further involvement of any company with this article in any other way. The authors declare that they have no relevant competing interests with respect to the contents of this article.

MKB, JCL and BD were responsible for drafting this article. All authors reviewed and approved the final version of the article.