Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259025
Status:
COMPLETED
Last Update Posted:
2008-08-11
First Post:
2005-11-25
Brief Title:
Intravenous n-3 Fatty Acids and Sudden Cardiac Death in Hemodialysis Patients
Sponsor:
Aalborg University Hospital
Organization:
Aalborg University Hospital
Study Overview
Official Title:
The Effect of Intravenous n-3 Polyunsaturated Fatty Acids on Risk Markers for Sudden Cardiac Death in Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Cardiovascular disease is the most common cause of death in haemodialysis HDpatients 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 deathSCD 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None