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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534300
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : April 16, 2015
Information provided by:
Aalborg Universitetshospital

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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Sudden Cardiac Death Drug: Omegaven Drug: Isotonic saline Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Intravenous Infusion of n-3 Polyunsaturated Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)
Study Start Date : October 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: A Drug: Omegaven
Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h)

Placebo Comparator: B Drug: Isotonic saline
Intravenous infusion, 100 mL, 25mL/h

Primary Outcome Measures :
  1. Inducibility of ventricular tachycardia [ Time Frame: Hours ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00534300

Department of Cardiology, Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg Universitetshospital
Principal Investigator: Trine Madsen, MD Aalborg Hospital, Aarhus University Hospital, Denmark

Responsible Party: Trine Madsen, Aalborg Hospital Identifier: NCT00534300     History of Changes
Other Study ID Numbers: IVN3ICD
EudraCT number: 2005-002386-37
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015

Keywords provided by Aalborg Universitetshospital:

Additional relevant MeSH terms:
Tachycardia, Ventricular
Death, Sudden, Cardiac
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden