Clinical trial NCT00110838: SOFA: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia
Official title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arrhythmia
Keywords: fish oil
n-3 fatty acids
n-3 PUFA
omega-3 fatty acids
arrhythmia
ICD
human
Patients with an implantable cardioverter defibrillator
Lead sponsor: Wageningen Centre for Food Sciences
Sponsor class: OTHER
Collaborators: name: SEAFOODplus
First posted: 2005-05-16
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD).

Detailed description: Previous human observational studies and clinical trials provide strong indications that n-3 PUFA from fish can prevent cardiovascular disease. Striking is that these studies show a strong relation between n-3 PUFA and sudden death, but not between n-3 PUFA and non-fatal heart disease. Sudden death is one of the most common and often the first manifestation of coronary heart disease. The majority of sudden deaths are directly caused by acute ventricular arrhythmia. Our hypothesis is that n-3 PUFA prevents sudden death by suppressing life-threatening cardiac arrhythmia. Therefore, we investigate in a randomized controlled clinical trial whether supplemental intake of n-3 PUFA from fish can reduce the incidence of life-threatening cardiac arrhythmias. Our population consists of patients with an implantable cardioverter defibrillator (ICD), because this device records all arrhythmic events in a memory chip. As the ICD enables continuous monitoring of events in nonhospitalised patients, this population is very suitable for testing a possible antiarrhythmic effect of n-3 PUFA. The objective of the SOFA trial is to investigate the effect of fish oil on the incidence of recurrent ventricular arrhythmia in patients with an ICD. The SOFA is a randomised, parallel, placebo-controlled, double-blind intervention study which is currently being carried out in 26 cardiology centers in Europe. Five hundred forty six patients with an ICD are randomised to receive either 2g/d of fish oil or placebo oil for a period up to 12 months. The primary outcome is spontaneous ventricular tachyarrhythmias as detected by the ICD or all-cause mortality within 12 months.

Eligibility criteria: Inclusion Criteria:

* ICD is capable of recording ECG strips for at least 10 of its (attempted) therapeutic interventions
* 18 years or older
* written informed consent

Exclusion Criteria:

* Primary prophylactic indication
* ICD implantation as a 'bridge' to heart transplantation
* Refractory supraventricular arrhythmias with rapid ventricular rates despite antiarrhythmic therapy
* a projected lifespan of less than 1 year
* participation in another trial (during or within 30 days before SOFA)
* use of any supplemental n-3 fatty acid during the last 3 months
* intake of more than 8g of n-3 fatty acids from fish per month as judged by a fish frequency questionnaire
* pregnant women and women of childbearing potential who do not use adequate contraception
* patients known to have a history of recent drug or alcohol abuse

Primary outcomes:
measure: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
Secondary outcomes:
measure: All cause mortality (separately from ventricular tachyarrhythmia)
measure: Cardiac mortality
measure: Myocardial infarction
measure: All arrhythmic events as documented by the ICD Core laboratory
measure: Change in the prescription of antiarrhythmic drugs
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Wilhelminenspital
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Brno
country: Czech Republic
facility: Interni Kardiologicka Klinika
city: Prague
country: Czech Republic
facility: Institute of Clinical and Experimental Medicine
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Klinikum Benjamin Franklin Berlin
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Jena
country: Germany
facility: Klinikum der Friedrich-Schiller-Universitat
city: Muenster
country: Germany
facility: Universitatsklinikum Muenster
city: Munich
country: Germany
facility: Stiftsklinik Augustinum
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre Amsterdam
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antoniusziekenhuis
city: Rotterdam
country: Netherlands
facility: University Medical Center Rotterdam Erasmus
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
city: Wageningen
country: Netherlands
facility: Wageningen Centre for Food Sciences
city: Zwolle
country: Netherlands
facility: Isala Klinieken (Locatie Wezenlanden)
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Katowice
country: Poland
facility: I Klinika Kardiologii
city: Szczecin
country: Poland
facility: Pomeranian Academy of Medicine
city: Warsaw
country: Poland
facility: Instytut Kardiologii
city: Warsaw
country: Poland
facility: Grochowski Hospital
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Voudois
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: St George Hospital Medical School
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Wageningen Centre for Food Sciences
name: Evert G Schouten, MD, PhD
role: STUDY_CHAIR
References:
citation: Brouwer IA, Zock PL, Wever EF, Hauer RN, Camm AJ, Bocker D, Otto-Terlouw P, Katan MB, Schouten EG. Rationale and design of a randomised controlled clinical trial on supplemental intake of n-3 fatty acids and incidence of cardiac arrhythmia: SOFA. Eur J Clin Nutr. 2003 Oct;57(10):1323-30. doi: 10.1038/sj.ejcn.1601695.
citation: Brouwer IA, Zock PL, Camm AJ, Bocker D, Hauer RN, Wever EF, Dullemeijer C, Ronden JE, Katan MB, Lubinski A, Buschler H, Schouten EG; SOFA Study Group. Effect of fish oil on ventricular tachyarrhythmia and death in patients with implantable cardioverter defibrillators: the Study on Omega-3 Fatty Acids and Ventricular Arrhythmia (SOFA) randomized trial. JAMA. 2006 Jun 14;295(22):2613-9. doi: 10.1001/jama.295.22.2613.