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

Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534300
• Other study ID #: IVN3ICD
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 21, 2007
• Last updated: April 15, 2015
• Start date: October 2007
• Est. completion date: June 2008

Study information

• Verified date: April 2015
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Drug:
• Omegaven
Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h)
• Isotonic saline
Intravenous infusion, 100 mL, 25mL/h

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Aalborg Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inducibility of ventricular tachycardia		Hours	No
Secondary	Heart rate variability		Hours	No
Secondary	Ventricular repolarization parameters		Hours	No
Secondary	Concentration of n-3 fatty acids in plasma and platelet membranes		Hours	No