Condition category
Circulatory System
Date applied
02/05/2007
Date assigned
02/05/2007
Last edited
01/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J.C. Lekkerkerker

ORCID ID

Contact details

Leiden University Medical Centre
Department of Cardiology
C5-P
PO Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 2020
j.c.lekkerkerker@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

ICD2

Study hypothesis

In patients on dialysis therapy, aged 55 to 80 years, Implantable Cardiac Device (ICD) therapy will reduce sudden cardiac (arrhythmic) death.

Ethics approval

Medical Ethics Committee (MEC) of the Leiden University Medical Centre (LUMC), 17/04/2007, ref: P07.016

Study design

Multicentre randomised active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Implantable Cardiac Device (ICD), Sudden Cardiac Death (SCD)

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/04/2007

Overall trial end date

01/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/04/2007

Recruitment end date

01/04/2017

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Centre
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

Department of Cardiology
PO Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/

Funders

Funder type

Industry

Funder name

Biotronik Nederland B.V. (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/06/2012: the overall trial end date was updated from 01/04/2012 to 01/04/2017.