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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00534300

Enrollment

Registered

2007-09-24

Start date

2007-10-31

Completion date

2008-06-30

Last updated

2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden Cardiac Death, Ventricular Tachycardia

Keywords

ICD-pacemaker

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.

Interventions

DRUGOmegaven

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

DRUGIsotonic saline

Intravenous infusion, 100 mL, 25mL/h

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Inducibility of ventricular tachycardia	Hours

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026