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

NCT ID: NCT00259025

Last Updated: 2008-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-07-31

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.

Conditions

Renal Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Jeppe H Christensen, MD, DMSci

Role: PRINCIPAL_INVESTIGATOR

Aalborg Sygehus

Locations

Department of Nephrology, Aalborg Hospital

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

IVN3DIALYSE

Identifier Type: -

Identifier Source: org_study_id