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

Sponsor

Aalborg University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00534300

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Oct 1, 2007

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Inducibility of ventricular tachycardia [Hours]

Secondary Outcome Measures

Heart rate variability [Hours]
Ventricular repolarization parameters [Hours]
Concentration of n-3 fatty acids in plasma and platelet membranes [Hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology, Aalborg Hospital	Aalborg		Denmark	9000

Sponsors and Collaborators

Aalborg University Hospital

Investigators

Principal Investigator: Trine Madsen, MD, Aalborg Hospital, Aarhus University Hospital, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00534300

Other Study ID Numbers:

IVN3ICD
EudraCT number: 2005-002386-37

First Posted:

Sep 24, 2007

Last Update Posted:

Apr 16, 2015

Last Verified:

Apr 1, 2015

Keywords provided by , ,

ICD-pacemaker

Additional relevant MeSH terms:

Tachycardia

Tachycardia, Ventricular

Death, Sudden, Cardiac

Death

Study Results

No Results Posted as of Apr 16, 2015