Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation

NCT ID: NCT00597220

Last Updated: 2011-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-08-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Omega 3

Group Type: EXPERIMENTAL

Omega 3 (n-3 PUFA)

Intervention Type: DIETARY_SUPPLEMENT

1 gram of n-3 PUFA containing DHA and EPA

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Omega 3 (n-3 PUFA)

1 gram of n-3 PUFA containing DHA and EPA

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Persistent atrial fibrillation

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion GESICA

OTHER

Sponsor Role: lead

Responsible Party

Fundacion GESICA

Principal Investigators

Hernan C Doval, MD

Role: STUDY_CHAIR

Fundacion GESICA

Gianni Tognoni, MD

Role: STUDY_CHAIR

Mario Negri Institute

Hugo Grancelli, MD

Role: STUDY_DIRECTOR

Fundacion GESICA

Sergio Varini, MD

Role: STUDY_DIRECTOR

Fundacion GESICA

Daniel Nul, MD

Role: STUDY_DIRECTOR

Fundacion GESICA

Alejandro Macchia, MD

Role: STUDY_DIRECTOR

Fundacion GESICA

Locations

Hospital Alemán

Caba, Buenos Aires, Argentina

Clinica Constituyentes

Caba, Buenos Aires, Argentina

Complejo Medico Policial Churruca Visca

Caba, Buenos Aires, Argentina

Fundacion Favaloro

Caba, Buenos Aires, Argentina

Hospital Evita Pueblo FEDITEC

Lanús, Buenos Aires, Argentina

Clinica y Maternidad Colon

Mar del Plata, Buenos Aires, Argentina

Hospital Privado de la Comunidad

Mar del Plata, Buenos Aires, Argentina

Hospital José de San Martín

Corrientes, Corrientes Province, Argentina

Clinica Romagosa

Córdoba, Córdoba Province, Argentina

Sanatorio Integral IOT

Misiones, Misiones Province, Argentina

Centro Cardiovascular Salta

Salta, Salta Province, Argentina

Sanatorio Parque

Rosario, Santa Fe Province, Argentina

CEMIC (Centro de Educación Médica e Investigaciones Clinicas Norberto Quirno)

Buenos Aires, , Argentina

Countries

Argentina

References

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.

Reference Type: DERIVED

PMID: 23265344 (View on PubMed)

Macchia 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.

Reference Type: DERIVED

PMID: 19249410 (View on PubMed)

Other Identifiers

FORWARD

Identifier Type: -

Identifier Source: org_study_id