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

Their will be a strong increase in incidence of end stage renal desease the
comming years. The risk of death is very high in dialysis patients. With 60% of
the total cardiovascular death sudden cardiac death is the largest cause of
mortality in dialysis patients. Implantable Cardioverter Defibrillators (ICD)
have proven to be effective in prevention of SCD in high risk patients. However
many studies have excluded patients with terminal renal insufficiency. Whether
benefit occurs in dialysis patients is unknown. We therefore designed a
prospective randomized study to evaluate the primary prevention of SCD in
dialysis patients. Futhermore we want to explore some risk factors of sudden
cardiac death in this group of patients.

The main objective of this study is to assess whether ICD therapy in dialysis
patients reduces sudden (arrhythmogenic) cardiac death.
The first secondary end point is to compare total mortality death between the
two groups. An other is to evaluate several factors contributing to the
arrhythmias in dialysis patients. Furthermore we want to measure the quality of
life (QOL) and also an economic assessment will be carried out.

The ICD2 study is a prospective, randomized controlled study. A total of 200
patients will be randomly assigned in a 1:1 ratio either to receive an ICD (ICD
group) of not to receive an ICD (control group).

After obtaining informed consent the patient will be invited to perform a TTE,
PWV and MSCT of the heart. Futhermore laboratory tests a lateral X-ray of the
lumbar abdominal aorta to assess calcification and a quality of life score will
be obtained. On patients who received a central venous line in the past a
venogram will be performed to assess stenosis of the vena subclavia. Patients
will be randomised

Patients randomised for ICD therapy will be admitted for 1 night to the
hospital for ICD implantation.
ICD patients will be invited to the ICD outpatient clinic after 2 months and
every 6 months thereafter. This visit will be combined at 12 months with
laboratory tests, a lateral X-ray of the lumbar abdominal aorta to assess
calcification and a quality of life score. A doppler echogram and a venogram of
the subclavian vein will be performed in all patients to assess possible
central venous stenosis.

The sudden cardiac death incidence in this growing group of patients is in our
opinion, a justification of this research. Especially since there are no other
large studies available on ICD use in dialysis patients.