A prospective Randomized Controlled Trial to Evaluate the Prevention of sudden cardiac death using implantable cardioverter defibrillators in dialysis patients.

Rationale:
Sudden cardiac death (SCD) is the single largest cause of death in dialysis patients. Implantable Cardioverter Defibrillator (ICD) has demonstrated to reduce the risk of SCD and all cause mortality in high risk patients. Whether ICD therapy benefits dialysis patients is unknown. We therefore designed a prospective randomized study to evaluate the primary prevention of SCD in dialysis patients.
Objective:
The main objective of this study is to assess whether ICD therapy in dialysis patients aged 55-80 years can reduce sudden cardiac (arrhythmic) death. Furthermore we will try to gain more insight in mechanisms of SCD in dialysis patients and try to find risk factors that predict SCD.
Study design:
A prospective randomized open-label trial.
Study population:
Dialysis patients aged 55-80 years.
Intervention (if applicable):
200 patients are randomised in ICD therapy (ICD group), and no ICD therapy (control group)
Main study parameters/endpoints:
It will test the hypothesis that ICD therapy will result in reduction of sudden cardiac (arrhythmic) death in dialysis patients.
Main study parameter is the difference in sudden cardiac (arrhythmic) death between ICD therapy and no ICD therapy groups. Secondly the incidence and types of arrhythmias and incidence of device-related complications will be evaluated. Furthermore we want evaluate if there is an association between potential risk factors (such as coronary artery calcification, left ventricular hypertrophy en dysfunction; arterial stiffness and endothelial function) and cardiovascular events and sudden cardiac death. Finally QOL and economic assessment will be carried out.

In patients on dialysis therapy, aged 55-80 year, inplanatable cardiac device (ICD) therapy will reduce sudden cardiac (arrythmic) death.

After patient has signed informed consent he will be invited to the LUMC for the assessment of an MSCT, TTE, pulse wave velocity of the aorta, laboratory tests and quality of life score list. A MSCT is performed to measure the coronary artery calcification and to exclude significant coronary stenosis. If there will be a more than 70% stenosis in the proximal LAD and/or left main coronary artery, irrespective of angina complaints, the patient will be referred to the local cardiologist for further evaluation and treatment. If associated pathology is found on the MSCT or TTE, the patient will be referred to a specialist in their own hospital. After these assessments randomisation will take place. Patients randomised for ICD therapy will be admitted to the LUMC for 1 night. In hemodialysis patients, the ICD will be implanted at the contra lateral side of the arteriovenous fistula. ICD patients will visit the ICD outpatients clinic at the LUMC every six months.