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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24816
Enrollment
200
Registered
2007-04-10
Start date
2007-04-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Sudden caridac Death (SCD), implantable cardiac device (ICD), Dialysis patients, risk factors for sudden cardiac death

Interventions

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 i

Sponsors

Leids University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactL.C.R. Hensen

Leiden University Medical Center Department of Cardiology C5-P

l.c.r.hensen@lumc.nl+31 (0)71 5262020

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)