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

NCT00534300 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-04-16

No results posted yet for this study

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

Interventions

DRUG

Omegaven

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

DRUG

Isotonic saline

Intravenous infusion, 100 mL, 25mL/h

Sponsors & Collaborators

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Trine Madsen, MD · Aalborg Hospital, Aarhus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00534300 on ClinicalTrials.gov