Atrial FibrillationPhase 3FORWARDNCT00597220
Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation
A Phase 3 study testing Omega 3 (n-3 PUFA) in people with Atrial Fibrillation, run by Fundacion GESICA at 13 sites in Argentina.
Trial summary
To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Omega 3 (n-3 PUFA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,600 participants
- Where
- 13 sitesArgentina
- Study dates
- Jan 2008to Aug 2011
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent atrial fibrillation
Who cannot join
- Contraindications or known hypersensitivity to n-3 PUFA
- Current treatment with n-3 PUFA for any reason
- Heart failure NYHA class IV
- Coronary artery bypass surgery or valve replacement within the past 3 months
- Planned cardiac procedures
- Known sick-sinus syndrome
Show all 15Show fewer
- Diagnosis of Wolff-Parkinson-White
- Clinical significant valvular etiologies
- Presence of arrhythmia associated with an acute reversible condition
- Advanced chronic lung disease
- Contraindications for anticoagulation therapy
- Pregnancy or lactation
- Any non cardiac illness associated with a life expectancy of < 2 years
- Treatment with any investigational agent within 3 month before randomization
- Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Argentina13 sites
CEMIC (Centro de Educación Médica e Investigaciones Clinicas Norberto Quirno)
Buenos Aires
Hospital Alemán
Caba, Buenos Aires, 1118
Clinica Constituyentes
Caba, Buenos Aires
Complejo Medico Policial Churruca Visca
Caba, Buenos Aires
Fundacion Favaloro
Caba, Buenos Aires
Clinica Romagosa
Córdoba, Córdoba Province
Hospital José de San Martín
Corrientes, Corrientes Province
Hospital Evita Pueblo FEDITEC
Lanus, Buenos Aires
Clinica y Maternidad Colon
Mar del Plata, Buenos Aires
Hospital Privado de la Comunidad
Mar del Plata, Buenos Aires
Sanatorio Integral IOT
Misiones, Misiones Province
Sanatorio Parque
Rosario, Santa Fe Province
Centro Cardiovascular Salta
Salta, Salta Province
About this study
Official title: Randomized, Prospective, Placebo-controlled, Multi-center Study to Test the Efficacy of n-3 PUFA for the Maintenance of Normal Sinus Rhythm in Patients With Persistent Atrial Fibrillation
To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.
Read the detailed description
Atrial fibrillation (AF) impose a substantial and growing economic burden on health care expenditures. In patients with persistent AF, there are fundamentally two ways to manage the arrhythmia: to restore and maintain sinus rhythm (rhythm control) or to allow AF to continue and ensure that the ventricular rate is controlled (rate control). As it has been stated, it goes without saying that if we could prevent atrial fibrillation (AF) or restore and maintain sinus rhythm in patients suffering from persistent AF, without any penalties due to the unwanted effects of drugs or incomplete suppression of AF and its thromboembolic complications, every physician would do so. Current strategies however, are limited to achieve such desirable goal. In the last years a growing amount of evidence and attention regarding the cardio-protective role of Omega 3 fatty acids (n-3 PUFA) became progressively clear and appealing.
Epidemiological studies and randomized controlled trials confirms the role of n-3 PUFA in reducing all cause mortality and cardiovascular events mostly in patients at high cardiovascular risk. These effects seems to be mediated mostly by an anti-arrhythmogenic effect.
Basic science confirms and extended clinical observations regarding the antiarrhythmogenic effect of these compounds. Recently both basic research and clinical science suggested a role of n-3 PUFA for the prevention and treatment of supraventricular arrhythmias, particularly AF.
The purpose of the study is to show that the addition of n-3 PUFA on the top of the best recommended therapies can improve the maintenance of normal sinus rhythm in patients with persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Omega 3 (n-3 PUFA), Placebo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 (n-3 PUFA)Dietary supplement
1 gram of n-3 PUFA containing DHA and EPA
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Omega 3 Receives: Dietary Supplement: Omega 3 (n-3 PUFA) |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival free of atrial fibrillation
Measured: 12 months
Secondary outcomes (5)
Number of patients in sinus rhythm at the time of each study visit
Measured: 12 months
Number of hospitalizations for CV reasons
Measured: 12 months
Number of all-cause hospitalizations
Measured: 12 months
Incidence of TE events
Measured: 12 months
Number of patients who die or with non-fatal thromboembolic events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2011 (estimated)
- Study completionAug 2011 (estimated)
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 Atrial FibrillationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion GESICA
- Sponsor type
- University, hospital or other
- Investigators
- Hernan C Doval, MD, Study chair, Fundacion GESICAGianni Tognoni, MD, Study chair, Mario Negri InstituteHugo Grancelli, MD, Study director, Fundacion GESICASergio Varini, MD, Study director, Fundacion GESICADaniel Nul, MD, Study director, Fundacion GESICAAlejandro Macchia, MD, Study director, Fundacion GESICA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597220
- Sponsor's protocol ID
- FORWARD
- Acronym
- FORWARD
- Status last verified
- Jun 2011
- First submitted
- 8 Jan 2008
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Macchia A, Grancelli H, Varini S, Nul D, Laffaye N, Mariani J, Ferrante D, Badra R, Figal J, Ramos S, Tognoni G, Doval HC; GESICA Investigators. Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) trial. J Am Coll Cardiol. 2013 Jan 29;61(4):463-468. doi: 10.1016/j.jacc.2012.11.021. Epub 2012 Dec 19.
PubMed 23265344Macchia A, Varini S, Grancelli H, Nul D, Laffaye N, Ferrante D, Tognoni G, Doval HC; FORomegaARD investigators. The rationale and design of the FORomegaARD Trial: A randomized, double-blind, placebo-controlled, independent study to test the efficacy of n-3 PUFA for the maintenance of normal sinus rhythm in patients with previous atrial fibrillation. Am Heart J. 2009 Mar;157(3):423-7. doi: 10.1016/j.ahj.2008.10.027. Epub 2009 Jan 8.
PubMed 19249410
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Placebo-controlled, Multi-center Study to Test the Efficacy of n-3 PUFA for the Maintenance of Normal Sinus Rhythm in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00597220
- Acronym / sponsor ID
- FORWARD / FORWARD
- Conditions
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Fundacion GESICAUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 17 Jan 2008 (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.
To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.
Detailed description
Atrial fibrillation (AF) impose a substantial and growing economic burden on health care expenditures. In patients with persistent AF, there are fundamentally two ways to manage the arrhythmia: to restore and maintain sinus rhythm (rhythm control) or to allow AF to continue and ensure that the ventricular rate is controlled (rate control). As it has been stated, it goes without saying that if we could prevent atrial fibrillation (AF) or restore and maintain sinus rhythm in patients suffering from persistent AF, without any penalties due to the unwanted effects of drugs or incomplete suppression of AF and its thromboembolic complications, every physician would do so. Current strategies however, are limited to achieve such desirable goal. In the last years a growing amount of evidence and attention regarding the cardio-protective role of Omega 3 fatty acids (n-3 PUFA) became progressively clear and appealing.
Epidemiological studies and randomized controlled trials confirms the role of n-3 PUFA in reducing all cause mortality and cardiovascular events mostly in patients at high cardiovascular risk. These effects seems to be mediated mostly by an anti-arrhythmogenic effect.
Basic science confirms and extended clinical observations regarding the antiarrhythmogenic effect of these compounds. Recently both basic research and clinical science suggested a role of n-3 PUFA for the prevention and treatment of supraventricular arrhythmias, particularly AF.
The purpose of the study is to show that the addition of n-3 PUFA on the top of the best recommended therapies can improve the maintenance of normal sinus rhythm in patients with persistent atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Omega 3 (n-3 PUFA)Omega 3 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persistent atrial fibrillation
Key exclusion criteria (15 listed)
- Contraindications or known hypersensitivity to n-3 PUFA
- Current treatment with n-3 PUFA for any reason
- Heart failure NYHA class IV
- Coronary artery bypass surgery or valve replacement within the past 3 months
- Planned cardiac procedures
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 |
|---|---|---|
| Omega 3 (n-3 PUFA)1 gram of n-3 PUFA containing DHA and EPA | Dietary supplement | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
Survival free of atrial fibrillation
Time frame: 12 months
5 secondary outcomes
Number of patients in sinus rhythm at the time of each study visit
Time frame: 12 months
Number of hospitalizations for CV reasons
Time frame: 12 months
Number of all-cause hospitalizations
Time frame: 12 months
Incidence of TE events
Time frame: 12 months
Number of patients who die or with non-fatal thromboembolic events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
- Derived from this study: PubMed 23265344Macchia A, Grancelli H, Varini S, Nul D, Laffaye N, Mariani J, Ferrante D, Badra R, Figal J, Ramos S, Tognoni G, Doval HC; GESICA Investigators. Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) trial. J Am Coll Cardiol. 2013 Jan 29;61(4):463-468. doi: 10.1016/j.jacc.2012.11.021. Epub 2012 Dec 19.
- Derived from this study: PubMed 19249410Macchia A, Varini S, Grancelli H, Nul D, Laffaye N, Ferrante D, Tognoni G, Doval HC; FORomegaARD investigators. The rationale and design of the FORomegaARD Trial: A randomized, double-blind, placebo-controlled, independent study to test the efficacy of n-3 PUFA for the maintenance of normal sinus rhythm in patients with previous atrial fibrillation. Am Heart J. 2009 Mar;157(3):423-7. doi: 10.1016/j.ahj.2008.10.027. Epub 2009 Jan 8.
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Atrial Fibrillation (AF)
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.
Hernan C Doval, MD study chair
Fundacion GESICA
Gianni Tognoni, MD study chair
Mario Negri Institute
Hugo Grancelli, MD study director
Fundacion GESICA
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega 3 (n-3 PUFA) in people with Atrial Fibrillation, run by Fundacion GESICA at 13 sites in Argentina.
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 1 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Argentina. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Survival free of atrial fibrillation (time frame: 12 months). 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 NCT00597220, 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 22 Jun 2011.