ArrhythmiaPhase 3NCT00110838
SOFA: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia
A Phase 3 study of Arrhythmia, run by Wageningen Centre for Food Sciences at 27 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 546 participants
- Where
- 27 sitesin 8 countries
- Study dates
- Oct 2001to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD is capable of recording ECG strips for at least 10 of its (attempted) therapeutic interventions
- 18 years or older
- written informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
27 sites in 8 countries.
27 sites in 8 countries
Germany7 sites
Kerckhoff-Klinik GmbH
Bad Nauheim, D-61231
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, D-32545
Klinikum Benjamin Franklin Berlin
Berlin, 12200
Charité - Universitätsmedizin Berlin
Berlin, 13353
Klinikum der Friedrich-Schiller-Universitat
Jena, D-07747
Stiftsklinik Augustinum
Munich, 81375
Universitatsklinikum Muenster
Münster, 48149
Netherlands7 sites
Academic Medical Centre Amsterdam
Amsterdam, 1105 AZ
Catharina Ziekenhuis
Eindhoven, 5623 EJ
St. Antoniusziekenhuis
Nieuwegein, 3435 CM
University Medical Center Rotterdam Erasmus
Rotterdam, 3015 GD
University Medical Centre Utrecht
Utrecht, 3584 CX
Wageningen Centre for Food Sciences
Wageningen, 6703 HD
Isala Klinieken (Locatie Wezenlanden)
Zwolle, 8011 JW
Poland5 sites
Medical University of Gdansk
Gdansk, 80-211
I Klinika Kardiologii
Katowice, 40-635
Pomeranian Academy of Medicine
Szczecin, 70-111
Instytut Kardiologii
Warsaw, 02-637
Grochowski Hospital
Warsaw, 04-073
United Kingdom3 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
St George Hospital Medical School
London, SW17 ORE
Southampton General Hospital
Southampton, SO16 6YD
Czechia2 sites
Interni Kardiologicka Klinika
Brno, 63900
Institute of Clinical and Experimental Medicine
Prague, 14021
About this study
Official title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
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).
Read the 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.
- Conditions
- Arrhythmia
- Being tested
- Supplementation with fish oil versus placebo
- Keywords
- fish oil, n-3 fatty acids, n-3 PUFA, omega-3 fatty acids, arrhythmia, ICD, human, Patients with an implantable cardioverter defibrillator
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation with fish oil versus placeboProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
Secondary outcomes (5)
All cause mortality (separately from ventricular tachyarrhythmia)
Cardiac mortality
Myocardial infarction
All arrhythmic events as documented by the ICD Core laboratory
Change in the prescription of antiarrhythmic drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2005 (estimated)
- Study startOct 2001
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 546 participants
Sponsor and investigators
- Lead sponsor
- Wageningen Centre for Food Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- SEAFOODplus
- Investigators
- Evert G Schouten, MD, PhD, Study chair, Wageningen Centre for Food Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110838
- Sponsor's protocol ID
- TME/C-01.07
- Status last verified
- May 2005
- First submitted
- 13 May 2005
- Last updated
- 21 Jul 2006
- Results posted
- No
Publications
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.
PubMed 14506496Brouwer 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.
PubMed 16772624
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
- ClinicalTrials.gov ID
- NCT00110838
- Acronym / sponsor ID
- TME/C-01.07
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants
- Lead sponsor
- Wageningen Centre for Food SciencesUniversity, hospital or other
- Collaborators
- SEAFOODplus
- Study start
- Oct 2001
- Study completion
- Jan 2005
- First posted
- 16 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICD is capable of recording ECG strips for at least 10 of its (attempted) therapeutic interventions
- 18 years or older
- written informed consent
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplementation with fish oil versus placebo | Procedure or surgery | – |
Primary outcome
Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
5 secondary outcomes
All cause mortality (separately from ventricular tachyarrhythmia)
Cardiac mortality
Myocardial infarction
All arrhythmic events as documented by the ICD Core laboratory
Change in the prescription of antiarrhythmic drugs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2006.
- Background: PubMed 14506496Brouwer 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.
- Results publication: PubMed 16772624Brouwer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evert G Schouten, MD, PhD study chair
Wageningen Centre for Food Sciences
27 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Arrhythmia, run by Wageningen Centre for Food Sciences at 27 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany, Netherlands, Poland, United Kingdom, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00110838, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2006.