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
|Condition or disease||Intervention/treatment||Phase|
|Renal Failure, Chronic||Drug: lipid emulsion with a high content of n-3 fatty acids||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
- Heart rate variability
- Ventricular repolarization, ventricular arrhythmias
- n-3 polyunsaturated fatty acids in plasma and cell membranes
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
|Department of Nephrology, Aalborg Hospital|
|Aalborg, Denmark, 9000|
|Principal Investigator:||Jeppe H Christensen, MD, DMSci||Aalborg Sygehus|