NCT00534300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

September 21, 2007

Last Update Submit

April 15, 2015

Conditions

Ventricular TachycardiaSudden Cardiac Death

Keywords

ICD-pacemaker

Outcome Measures

Primary Outcomes (1)

  • Inducibility of ventricular tachycardia

    Hours

Secondary Outcomes (3)

  • Heart rate variability

    Hours

  • Ventricular repolarization parameters

    Hours

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

    Hours

Study Arms (2)

A

EXPERIMENTAL
Drug: Omegaven

B

PLACEBO COMPARATOR
Drug: Isotonic saline

Interventions

OmegavenDRUG

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

A
Isotonic salineDRUG

Intravenous infusion, 100 mL, 25mL/h

B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Aalborg Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Tachycardia, VentricularDeath, Sudden, Cardiac

Interventions

fish oil triglyceridesSodium Chloride

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsHeart ArrestDeath, SuddenDeath

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Trine Madsen, MD

    Aalborg Hospital, Aarhus University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 24, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

DK(1)