Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Intravenous Infusion of n-3 Polyunsaturated Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)

Conditions
-----------------
Ventricular Tachycardia, Sudden Cardiac Death

Intervention / Treatment
-----------------
* Drug: Omegaven
* Drug: Isotonic saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sustained ventricular tachycardia (VT) inducible during primary electrophysiological study (before ICD implantation) and one of the following Latest VT episode terminated by anti-tachycardia pacing (ATP) VT induced during primary electrophysiological study terminated by ATP Exclusion Criteria: Premenopausal women Allergy to fish or egg protein Blood pressure > 160/90 (treated or untreated) MI, PCI or CABG within the previous 6 months HbA1c > 10% ALT > 150 U/L INR > 3.5 Plasma-potassium < 3.5 mmol/L Fasting triglycerides > 3 mmol/L Other serious illness Inability to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Omegaven<br>* Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h)<br>|
| Placebo Comparator: B<br> | Drug: Isotonic saline<br>* Intravenous infusion, 100 mL, 25mL/h<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inducibility of ventricular tachycardia |  | Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability |  | Hours | 
| Ventricular repolarization parameters |  | Hours | 
| Concentration of n-3 fatty acids in plasma and platelet membranes |  | Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD-pacemaker