Intravenous infusion of n-3 polyunsaturated fatty acids and ventricular tackycardi in patients with implantable cardioverter defibrillator (ICD)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002386-37-DK

Enrollment

Unknown

Registered

2007-07-30

Start date

2007-08-24

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with an implantable cardioverter defibrillator (ICD-unit) for treatment for cardiac ventricular arrhythmias and for prevention of sudden cardiac death

Interventions

Trade Name: Omegaven Pharmaceutical Form: Emulsion for infusion Other descriptive name: eicosapentaenoic acid Concentration unit: g gram(s) Concentration type: range Concentration number: 1.25-2.82 Ot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with an implantable cardioverter defibrillator (ICD) implanted at least 3 months prior to inclusion. Sustained ventricular tackycardia was inducible during the primary electrophysiological testing prior to implantation of the ICD. History of successfull treatment of a ventricular tackycardia episode with anti-tackycardia pacing (ATP) either the primary electrophysiological testing or at a later time point Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergy to fish or egg protein. Blood pressure > 160/90 (with or without treatment). Myocardial infarction or coronary revascularisation within the previous 6 months. HbA1c >10 %. Plasma-creatinine > 200 microM Plasma-alanineaminotransferase > 150 U/L INR > 3.5 Plasma-potassium > 3.5 mM Fasting triglycerides > 3 mM Ongoing infection Other serious illlness Inability to informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the immediate effect of intravenous infusion of n-3 polyunsaturated fatty acids on the induction of sustained ventricular tackycardia during electrophysiological testing in patients with implantable cardioverter defibrillators. ;Secondary Objective: To investigate the immediate effect of intravenous infusion of n-3 polyunsaturated fatty acids on risk markers for sudden cardiac death (in 12-lead ECG and Holter recordings). To investigate the effect of intravenous infusion of n-3 polyunsaturated fatty acids på the concentration of n-3 free fatty acids in plasma and on the concentration of n-3 polyunsaturated fatty acids in plasma phospholipids and platelet membrane phospholipids.;Primary end point(s): Comparision of the fractions of patients in whom sustained ventricular tackycardia can be induced after intravenous n-3 polyunsaturated fatty acids and after placebo. If ventricular tackycardia can be induced after both treatments, a comparision of how many extrasystoles that are necessary to induce ventricular tackycardia.	—

Measure

Time frame

Main Objective: To investigate the immediate effect of intravenous infusion of n-3 polyunsaturated fatty acids on the induction of sustained ventricular tackycardia during electrophysiological testing in patients with implantable cardioverter defibrillators. ;Secondary Objective: To investigate the immediate effect of intravenous infusion of n-3 polyunsaturated fatty acids on risk markers for sudden cardiac death (in 12-lead ECG and Holter recordings). To investigate the effect of intravenous infusion of n-3 polyunsaturated fatty acids på the concentration of n-3 free fatty acids in plasma and on the concentration of n-3 polyunsaturated fatty acids in plasma phospholipids and platelet membrane phospholipids.;Primary end point(s): Comparision of the fractions of patients in whom sustained ventricular tackycardia can be induced after intravenous n-3 polyunsaturated fatty acids and after placebo. If ventricular tackycardia can be induced after both treatments, a comparision of how many extrasystoles that are necessary to induce ventricular tackycardia.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026