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

A prospective Randomized Controlled Trial to Evaluate the Primary Prevention of sudden cardiac death using implantable cardioverter defibrillators in dialysis patients. - Implantable cardioverter device in dialysis patients. ICD2 study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44083

Enrollment

200

Registered

2007-03-15

Start date

2007-07-25

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sudden cardiac death

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary end point is sudden (arrhythmogenic) cardiac death. Cause of death will be classified as being caused by arrhythmia, other cardiac, vascular noncardiac, or nonvascular.	—

Secondary

Measure	Time frame
Overall Mortality will be a secondary end point. Other secondary end points are: Device ralated complications Measurement of quality of life (QOL). Economic assessment will be carried out.	—

Countries

Netherlands

Outcome results