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

Phase 4

Completed

• Conditions: sudden cardiac death; 10029149; arrhythmogenic death; 10007521

• Registration Number: NL-OMON44083
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

-Patients 55 to 80 years of age
-End Stage Renal Disease (ESRD)
-> 90 days after start dialysis
-Not eligible for kidney transplantation or kidney transplantation not expected within 3 years after inclusion;zie protocol p 21

Exclusion Criteria

-Terminal congestive heart failure according NYHA class 4 at time of randomization
-Non arrhythmic medical condition making 1-year survival unlikely
-Excessive perioperative risk for ICD implantation
-HIV infection
-Patients with central venous line
-Acute Myocardial Infarction (AMI) last 40 days
-ICD indication according current guidelines
-SCD survivors
-(non) ischemic cardiomyopathy with LVEF<30%Not able to sign informed consent
-Expected poor compliance with protocol
-Inclusion in other study protocols

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point is sudden (arrhythmogenic) cardiac death.<br /><br>Cause of death will be classified as being caused by arrhythmia, other cardiac,<br /><br>vascular noncardiac, or nonvascular. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Overall Mortality will be a secondary end point.<br /><br>Other secondary end points are:<br /><br>Device ralated complications<br /><br>Measurement of quality of life (QOL).<br /><br>Economic assessment will be carried out.</p><br>