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

Phase 1

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

• Registration Number: EUCTR2005-002386-37-DK
• Lead Sponsor: Department of Cardiology, Aalborg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-30
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified