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
  Purpose

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.


Condition Intervention Phase
Renal Failure, Chronic
Drug: lipid emulsion with a high content of n-3 fatty acids
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effect of Intravenous n-3 Polyunsaturated Fatty Acids on Risk Markers for Sudden Cardiac Death in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Heart rate variability

Secondary Outcome Measures:
  • Ventricular repolarization, ventricular arrhythmias
  • n-3 polyunsaturated fatty acids in plasma and cell membranes

Enrollment: 60
Study Start Date: September 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259025

Locations
Denmark
Department of Nephrology, Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg Universityhospital
Investigators
Principal Investigator: Jeppe H Christensen, MD, DMSci Aalborg Sygehus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00259025     History of Changes
Other Study ID Numbers: IVN3DIALYSE
Study First Received: November 25, 2005
Last Updated: August 8, 2008
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Aalborg Universityhospital:
Renal failure, chronic
Death, sudden, cardiac
Heart rate variability
Tachycardia, ventricular
Ventricular premature complexes
Ventricular repolarization
Eicosapentaenoic acid
Docosahexaenoic acid

Additional relevant MeSH terms:
Renal Insufficiency
Death, Sudden, Cardiac
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Death
Pathologic Processes
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 18, 2014