Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker
The long-chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), appear to offer protection against sudden cardiac death and ventricular arrhythmias. EPA and DHA are essential fatty acids which are incorporated into cellular membranes after regular ingestion of fatty fish or fish oil.
This study investigates a possible acute effect of intravenous infusion of n-3 PUFA on inducibility of ventricular tachycardia (VT) in patients with an ICD-pacemaker.
The hypothesis is that an acute rise in the concentration of n-3 PUFA in plasma will increase the electric stability of the myocardial cells, so that VT is more difficult to induce.
In a randomized, placebo-controlled, double-blind, crossover study, a lipid emulsion with a high content of n-3 PUFA (or placebo: isotonic saline) will be administered intravenously before a non-invasive electrophysiologic examination performed via the ICD and following a predefined protocol.
The main outcome is inducibility of VT. If sustained VT is induced in a patient after both n-3 PUFA and placebo, the strength of the required stimulus after n-3 PUFA and after placebo is compared.
Sudden Cardiac Death
Drug: Isotonic saline
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
|Official Title:||Intravenous Infusion of n-3 Polyunsaturated Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)|
- Inducibility of ventricular tachycardia [ Time Frame: Hours ] [ Designated as safety issue: No ]
- Heart rate variability [ Time Frame: Hours ] [ Designated as safety issue: No ]
- Ventricular repolarization parameters [ Time Frame: Hours ] [ Designated as safety issue: No ]
- Concentration of n-3 fatty acids in plasma and platelet membranes [ Time Frame: Hours ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h)
|Placebo Comparator: B||
Drug: Isotonic saline
Intravenous infusion, 100 mL, 25mL/h
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534300
|Department of Cardiology, Aalborg Hospital|
|Aalborg, Denmark, 9000|
|Principal Investigator:||Trine Madsen, MD||Aalborg Hospital, Aarhus University Hospital, Denmark|