Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker
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|ClinicalTrials.gov Identifier: NCT00534300|
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : April 16, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia Sudden Cardiac Death||Drug: Omegaven Drug: Isotonic saline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Intravenous Infusion of n-3 Polyunsaturated Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
U.S. FDA Resources
Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h)
|Placebo Comparator: B||
Drug: Isotonic saline
Intravenous infusion, 100 mL, 25mL/h
- Inducibility of ventricular tachycardia [ Time Frame: Hours ]
- Heart rate variability [ Time Frame: Hours ]
- Ventricular repolarization parameters [ Time Frame: Hours ]
- Concentration of n-3 fatty acids in plasma and platelet membranes [ Time Frame: Hours ]
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): NCT00534300
|Department of Cardiology, Aalborg Hospital|
|Aalborg, Denmark, 9000|
|Principal Investigator:||Trine Madsen, MD||Aalborg Hospital, Aarhus University Hospital, Denmark|