Clinical trial NCT00259025: Intravenous n-3 Fatty Acids and Sudden Cardiac Death in Hemodialysis Patients
Official title: The Effect of Intravenous n-3 Polyunsaturated Fatty Acids on Risk Markers for Sudden Cardiac Death in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Failure, Chronic
Keywords: Renal failure, chronic
Death, sudden, cardiac
Heart rate variability
Tachycardia, ventricular
Ventricular premature complexes
Ventricular repolarization
Eicosapentaenoic acid
Docosahexaenoic acid
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2005-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Heart rate variability
Secondary outcomes:
measure: Ventricular repolarization, ventricular arrhythmias
measure: n-3 polyunsaturated fatty acids in plasma and cell membranes
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Nephrology, Aalborg Hospital
Study officials:
affiliation: Aalborg Sygehus
name: Jeppe H Christensen, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
References: