A prospective Randomized Controlled Trial to Evaluate the Prevention of sudden cardiac death using implantable cardioverter defibrillators in dialysis patients.
Recruiting
- Conditions
- Sudden caridac Death (SCD), implantable cardiac device (ICD), Dialysis patients, risk factors for sudden cardiac death
- Registration Number
- NL-OMON24816
- Lead Sponsor
- eids University Medical Center (LUMC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 1. To determine that prophylactic ICD therapy will result in reduction of all cause mortality in dialysis patients;<br>2. To assess the incidence and types of ventricular and supra ventricular arrhythmias;<br>3. To assess the relation with LVH, CAC and arterial stiffness and cardiovascular and sudden cardiac death;<br>4. To assess the safety, costs and quality of life, of ICD therapy in dialysis patients.<br>