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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00259025
Enrollment
60
Registered
2005-11-29
Start date
2006-09-30
Completion date
2007-07-31
Last updated
2008-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

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

Sponsors

Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Heart rate variability

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026