Intravenous n-3 Fatty Acids and Sudden Cardiac Death in Hemodialysis Patients

This study has been completed.

Sponsor:

Information provided by:

Aalborg Universityhospital

ClinicalTrials.gov Identifier:

NCT00259025

First received: November 25, 2005

Last updated: August 8, 2008

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

November 25, 2005

Last Updated Date

August 8, 2008

Start Date ^ICMJE

September 2006

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Heart rate variability

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00259025 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Ventricular repolarization, ventricular arrhythmias
n-3 polyunsaturated fatty acids in plasma and cell membranes

Original Secondary Outcome Measures ^ICMJE

Ventricular arrhythmias
n-3 polyunsaturated fatty acids in plasma and cell membranes

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intravenous n-3 Fatty Acids and Sudden Cardiac Death in Hemodialysis Patients

Official Title ^ICMJE

The Effect of Intravenous n-3 Polyunsaturated Fatty Acids on Risk Markers for Sudden Cardiac Death in Hemodialysis Patients

Brief Summary

The main purpose of this study is to investigate whether intravenous infusion of a lipid emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis patients.

Detailed Description

Cardiovascular disease is the most common cause of death in haemodialysis (HD)patients, and half of these deaths are due to sudden cardiac death caused by ventricular arrhythmias. HD patients have an attenuated heart rate variability (HRV) and a high frequency of ventricular arrhythmias, both of which are predictors of sudden cardiac death(SCD). n-3 polyunsaturated fatty acids (PUFA) improves HRV and reduces the risk of SCD. n-3 PUFAs are obtained from fatty fish and fish oil and are incorporated into cell membranes after long-term ingestion. However, it is not known if this incorporation is essential or merely serves as storage for n-3 free PUFAs to be release during for instance myocardial ischaemia.

The study hypothesis is that intravenous infusion of a lipid emulsion with a high content of n-3 PUFAs will improve HRV and ventricular repolarization and reduce ventricular arrhythmias via an acute increase in free non-esterified n-3 PUFAs in plasma.

In a randomized, placebo-controlled design a n-3 PUFA rich emulsion (or placebo) will be administered during hemodialysis treatment. The two study groups will be compared with respect to heart rate variability, ventricular repolarization parameters, ventricular ectopic beats and arrhythmias and the content of n-3 PUFA in plasma and cell membranes will be compared.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Condition ^ICMJE

Renal Failure, Chronic

Intervention ^ICMJE

Drug: lipid emulsion with a high content of n-3 fatty acids

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age > 18 yrs
End-stage renal failure
Maintenance haemodialysis treatment > 3 months

Exclusion Criteria:

Allergy to fish or egg protein
Body weight < 50 kgs
Chronic supraventricular tachycardia
Implanted pacemaker
Myocardial infarction within 6 months
PCI or CABG within 6 months
Stroke or TIA within 6 months
HbA1C > 10 %
ALAT > 100 U/l
Triglycerides > 3 mmol/l
Ongoing infection
Tendency to severe blood pressure drops during dialysis treatment
Malignancy
Psychiatric disorder
Pregnancy

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00259025

Other Study ID Numbers ^ICMJE

IVN3DIALYSE

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Aalborg Universityhospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jeppe H Christensen, MD, DMSci

Aalborg Sygehus

Information Provided By

Aalborg Universityhospital

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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