Intravenous n-3 Fatty Acids and Sudden Cardiac Death in Hemodialysis Patients
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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 |
- Heart rate variability
- 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) |
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 |
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
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:
|
Kidney Failure, Chronic Renal Insufficiency Death, Sudden, Cardiac Death Renal Insufficiency, Chronic Kidney Diseases |
Urologic Diseases Heart Arrest Heart Diseases Cardiovascular Diseases Death, Sudden Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013