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

Aalborg University Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sudden Cardiac Death; Ventricular Tachycardia

Treatments: Drug: Isotonic saline; Drug: Omegaven

Study type: Interventional

Funder types: Other

Identifiers

NCT00534300

IVN3ICD

EudraCT number: 2005-002386-37

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Omegaven

B

Placebo Comparator group

Treatment:

Drug: Isotonic saline