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

Renal Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259025
• Other study ID #: IVN3DIALYSE
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2005
• Last updated: August 8, 2008
• Start date: September 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2008
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Kidney Failure, Chronic
• Renal Failure, Chronic
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Nephrology, Aalborg Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability
Secondary	Ventricular repolarization, ventricular arrhythmias
Secondary	n-3 polyunsaturated fatty acids in plasma and cell membranes