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Sponsored by: |
Aalborg Hospital |
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Information provided by: | Aalborg Hospital |
ClinicalTrials.gov Identifier: | NCT00259025 |
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 II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Intravenous n-3 Polyunsaturated Fatty Acids on Risk Markers for Sudden Cardiac Death in Hemodialysis Patients |
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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | IVN3DIALYSE |
Study First Received: | November 25, 2005 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00259025 |
Health Authority: | Denmark: Danish Medicines Agency |
Renal failure, chronic Death, sudden, cardiac Heart rate variability Tachycardia, ventricular |
Ventricular premature complexes Ventricular repolarization Eicosapentaenoic acid Docosahexaenoic acid |
Death Renal Insufficiency Heart Diseases Ventricular Premature Complexes Tachycardia Kidney Failure, Chronic Heart Arrest |
Urologic Diseases Renal Insufficiency, Chronic Death, Sudden Death, Sudden, Cardiac Kidney Diseases Tachycardia, Ventricular Kidney Failure |
Pathologic Processes Cardiovascular Diseases |