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

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ClinicalTrials.gov Identifier: NCT00259025
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : August 11, 2008
Sponsor:
Information provided by:

Study Description
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.

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Intravenous n-3 Polyunsaturated Fatty Acids on Risk Markers for Sudden Cardiac Death in Hemodialysis Patients
Study Start Date : September 2006
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Heart rate variability

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259025


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

ClinicalTrials.gov Identifier: NCT00259025     History of Changes
Other Study ID Numbers: IVN3DIALYSE
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: August 11, 2008
Last Verified: April 2008

Keywords provided by Aalborg Universitetshospital:
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
Death, Sudden, Cardiac
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Renal Insufficiency, Chronic