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

This study has been completed.
Sponsor:
Information provided by:
Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT00534300
First received: September 21, 2007
Last updated: August 8, 2008
Last verified: August 2008
History of Changes
  Purpose

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 Intervention Phase
Ventricular Tachycardia
Sudden Cardiac Death
 Drug: Omegaven
Drug: Isotonic saline
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Intravenous Infusion of n-3 Polyunsaturated Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Inducibility of ventricular tachycardia [ Time Frame: Hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate variability [ Time Frame: Hours ] [ Designated as safety issue: No ]
  • Ventricular repolarization parameters [ Time Frame: Hours ] [ Designated as safety issue: No ]
  • Concentration of n-3 fatty acids in plasma and platelet membranes [ Time Frame: Hours ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534300

Locations
Denmark
Department of Cardiology, Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg Universityhospital
Investigators
Principal Investigator: Trine Madsen, MD Aalborg Hospital, Aarhus University Hospital, Denmark
  More Information

No publications provided

Responsible Party: Trine Madsen, Aalborg Hospital
ClinicalTrials.gov Identifier: NCT00534300     History of Changes
Other Study ID Numbers: IVN3ICD, EudraCT number: 2005-002386-37
Study First Received: September 21, 2007
Last Updated: August 8, 2008
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Aalborg Universityhospital:
ICD-pacemaker

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

ClinicalTrials.gov processed this record on May 16, 2013