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

Phase 1

Completed

• Conditions: Ventricular Tachycardia; Sudden Cardiac Death
• Interventions: Drug: Isotonic saline; Drug: Omegaven

• Registration Number: NCT00534300
• Lead Sponsor: Aalborg University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-21
• Study First Submitted QC: 2007-09-21
• Study First Posted: 2007-09-24
• Study Start: 2007-10
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Isotonic saline	-
A	Omegaven	-

Primary Outcome Measures

Name	Time	Method
Inducibility of ventricular tachycardia	Hours

Secondary Outcome Measures

Name	Time	Method
Heart rate variability	Hours
Ventricular repolarization parameters	Hours
Concentration of n-3 fatty acids in plasma and platelet membranes	Hours

Trial Locations

Locations (1)

Department of Cardiology, Aalborg Hospital; 🇩🇰 Aalborg, Denmark