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

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR948
• Date of registration: 10/04/2007
• Primary sponsor: Leiden University Medical Center (LUMC), Department of Cardiology
• Public title: A prospective Randomized Controlled Trial to Evaluate the Prevention of sudden cardiac death using implantable cardioverter defibrillators in dialysis patients.
• Scientific title: A prospective Randomized Controlled Trial to Evaluate the Prevention of sudden cardiac death using implantable cardioverter defibrillators in dialysis patients. - ICD2 - trial
• Date of first enrolment: 1/4/2007
• Target sample size: 200
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=948
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: J.W. Jukema

• Name: J.C. Lekkerkerker

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients 55 to 80 years of age;
2. End Stage Renal Disease (ESRD);
3. > 90 days after start dialysis.

Exclusion criteria: 1. Possible living kidney donation;
2. Terminal congestive heart failure according NYHA class 4 at time of randomization;
3. Non arrhythmic medical condition making 1-year survival unlikely;
4. Excessive perioperative risk for ICD implantation;
5. HIV infection;
6. Patients with central venous line;
7. Acute Myocardial Infarction (AMI) last 40 days;
8. ICD indication according current guidelines;
9. Expected poor compliance with protocol.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Dialysis patients, Sudden caridac death (SCD), Implantable cardiac device (ICD)

Intervention(s)

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.

Primary Outcome(s)

To determine whether ICD therapy in dialysis patients aged 55-80 years results in significant reduction in sudden cardiac (arrhythmic) death rates when compared to no ICD therapy. Cause of death will be classified as being caused by arrhythmia, other cardiac, vascular noncardiac, or nonvascular.

Secondary Outcome(s)

1. To determine that prophylactic ICD therapy will result in reduction of all cause mortality in dialysis patients;
2. To assess the incidence and types of ventricular and supra ventricular arrhythmias;
3. To assess the relation with LVH, CAC and arterial stiffness and cardiovascular and sudden cardiac death;
4. To assess the safety, costs and quality of life, of ICD therapy in dialysis patients.

Secondary ID(s)

ISRCTN20479861

Source(s) of Monetary Support

Biotronik