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

NCT ID: NCT00534300

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-06-30

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.

Conditions

Ventricular Tachycardia; Sudden Cardiac Death

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: TRIPLE

Study Groups

A

Group Type: EXPERIMENTAL

Omegaven

Intervention Type: DRUG

Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h)

B

Group Type: PLACEBO_COMPARATOR

Isotonic saline

Intervention Type: DRUG

Intravenous infusion, 100 mL, 25mL/h

Interventions

Omegaven

Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h)

Intervention Type: DRUG

Isotonic saline

Intravenous infusion, 100 mL, 25mL/h

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aalborg Hospital

Principal Investigators

Trine Madsen, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg Hospital, Aarhus University Hospital, Denmark

Locations

Department of Cardiology, Aalborg Hospital

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

EudraCT number: 2005-002386-37

Identifier Type: -

Identifier Source: secondary_id

IVN3ICD

Identifier Type: -

Identifier Source: org_study_id