A prospective randomised controlled trial to evaluate the prevention of sudden cardiac death using Implantable Cardioverter Defibrillators in dialysis patients

Not Applicable

Completed

• Conditions: Circulatory System; Sudden cardiac death; Implantable cardiac device (ICD), sudden cardiac death (SCD)

• Registration Number: ISRCTN20479861
• Lead Sponsor: eiden University Medical Centre (LUMC) (The Netherlands)

Brief Summary

2008 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/18561878 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30882234 results (added 04/11/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33606179/ qualitative results (added 22/02/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36016586/ Prevalence of central venous stenosis (added 30/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-02
• Study Completion: 2019-05-01
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

1. Patients 55 to 80 years of age
2. End Stage Renal Disease (ESRD)
3. Greater than 90 days after start dialysis

Exclusion Criteria

1. Possible living kidney donation
2. Terminal congestive heart failure according New York Heart Association (NYHA) class four at time of randomisation
3. Non-arrhythmic medical condition making one-year survival unlikely
4. Excessive perioperative risk for ICD implantation
5. Human Immunodeficiency Virus (HIV) infection
6. Patients with central venous line
7. Acute Myocardial Infarction (AMI) in the 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
Sudden cardiac (arrhythmic) death rates. Cause of death will be classified as being caused by arrhythmia, other cardiac, vascular noncardiac, or nonvascular.

Secondary Outcome Measures

Name	Time	Method
<br> 1. All cause mortality<br> 2. Incidence and types of ventricular and supra ventricular arrhythmias<br> 3. Relation with Left Ventricular Hypertrophy (LVH), Coronary Artery Calcium (CAC) and arterial stiffness and cardiovascular and sudden cardiac death<br> 4. Safety, costs and quality of life<br>