Skip to main content
OpenTrials
Completed

NCT Number: NCT00534300

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death Tachycardia Tachycardia, Ventricular

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Cardiology, Aalborg Hospital

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omegaven

Drug

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

Isotonic saline

Drug

Intravenous infusion, 100 mL, 25mL/h

Primary outcomes

  1. Inducibility of ventricular tachycardia

    Time frame: Hours

Secondary outcomes

  1. Heart rate variability

    Time frame: Hours

  2. Ventricular repolarization parameters

    Time frame: Hours

  3. Concentration of n-3 fatty acids in plasma and platelet membranes

    Time frame: Hours

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 24, 2007
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.