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ISRCTN
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ISRCTN20479861
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DOI
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10.1186/ISRCTN20479861
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A prospective randomised controlled trial to evaluate the prevention of sudden cardiac death using Implantable Cardioverter Defibrillators in dialysis patients
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Scientific title
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Acronym
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ICD2 - trial
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Serial number at source
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N/A
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Study hypothesis
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In patients on dialysis therapy, aged 55 to 80 years, Implantable Cardiac Device (ICD) therapy will reduce sudden cardiac (arrhythmic) death.
As of 12/06/2012, the anticipated end date for this trial has been updated from 01/04/2012 to 01/04/2017.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Approval received from the Medical Ethics Committee (MEC) of the Leiden University Medical Centre (LUMC) on the 17th April 2007 (ref: P07.016).
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Study design
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Multicentre, randomised, active controlled, parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Implantable Cardiac Device (ICD), Sudden Cardiac Death (SCD)
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Participants - inclusion criteria
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1. Patients 55 to 80 years of age
2. End Stage Renal Disease (ESRD)
3. Greater than 90 days after start dialysis
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2007
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Anticipated end date
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01/04/2017
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200 (As of 12/06/2012, the end date of patient inclusion has been changed to 2014 with a 3 year follow-up after last
inclusion)
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Interventions
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After the patient has signed the informed consent he will be invited to the Leiden University Medical Centre (LUMC) for the assessment of a Multislice Computed Tomography (MSCT), Transthoracic Echocardiography (TTE), pulse wave velocity of the aorta, X-aorta, laboratory tests and quality of life score list. A MSCT is performed to measure the coronary artery calcification and to exclude significant coronary stenosis. If there will be a more than 70% stenosis in the proximal Left Anterior Descending (LAD) and/or left main coronary artery, irrespective of angina complaints, the patient will be referred to the local cardiologist for further evaluation and treatment. If associated pathology is found on the MSCT or TTE, the patient will be referred to a specialist in their own hospital.
After these assessments randomisation will take place. Patients randomised for ICD therapy will be admitted to the LUMC for one night. In haemodialysis patients, the ICD will be implanted at the contra-lateral side of the arteriovenous fistula. ICD patients will visit the ICD outpatients clinic at the LUMC every six months.
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Primary outcome measure(s)
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To determine whether ICD therapy in dialysis patients aged 55 to 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.
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Secondary outcome measure(s)
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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 Left Ventricular Hypertrophy (LVH), Coronary Artery Calcium (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
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Sources of funding
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Biotronik Nederland B.V. (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
J.C.
Lekkerkerker
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Address
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Leiden University Medical Centre
Department of Cardiology, C5-P
P.O. Box 9600
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City/town
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Leiden
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Zip/Postcode
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2300 RC
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Country
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Netherlands
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Tel
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+31 (0)71 526 2020
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Fax
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+31 (0)71 526 6809
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Email
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j.c.lekkerkerker@lumc.nl
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Sponsor
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Leiden University Medical Centre (LUMC) (The Netherlands)
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Address
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Department of Cardiology
P.O. Box 9600
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City/town
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Leiden
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Zip/Postcode
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2300 RC
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Country
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Netherlands
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Sponsor website:
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http://www.lumc.nl/
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Date applied
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02/05/2007
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Last edited
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12/06/2012
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Date ISRCTN assigned
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02/05/2007
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