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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00597220
Recruitment Status : Unknown
Verified June 2011 by Fundacion GESICA.
Recruitment status was:  Active, not recruiting
First Posted : January 17, 2008
Last Update Posted : June 22, 2011
Information provided by:
Fundacion GESICA

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Dietary Supplement: Omega 3 (n-3 PUFA) Drug: Placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2008
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Omega 3
Dietary Supplement: Omega 3 (n-3 PUFA)
1 gram of n-3 PUFA containing DHA and EPA
Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. Survival free of atrial fibrillation [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of patients in sinus rhythm at the time of each study visit [ Time Frame: 12 months ]
  2. Number of hospitalizations for CV reasons [ Time Frame: 12 months ]
  3. Number of all-cause hospitalizations [ Time Frame: 12 months ]
  4. Incidence of TE events [ Time Frame: 12 months ]
  5. Number of patients who die or with non-fatal thromboembolic events [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00597220

Hospital Alemán
Caba, Buenos Aires, Argentina, 1118
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
Lanus, Buenos Aires, Argentina
Clinica y Maternidad Colon
Mar del Plata, Buenos Aires, Argentina
Hospital Privado de la Comunidad
Mar del Plata, Buenos Aires, Argentina
Sanatorio Parque
Rosario, Santa Fe, Argentina
CEMIC (Centro de Educación Médica e Investigaciones Clinicas Norberto Quirno)
Ciudad Autonoma de Buenos Aires, Argentina
Clinica Romagosa
Cordoba, Argentina
Hospital José de San Martín
Corrientes, Argentina
Sanatorio Integral IOT
Misiones, Argentina
Centro Cardiovascular Salta
Salta, Argentina
Sponsors and Collaborators
Fundacion GESICA
Study Chair: Hernan C Doval, MD Fundacion GESICA
Study Chair: Gianni Tognoni, MD Mario Negri Institute
Study Director: Hugo Grancelli, MD Fundacion GESICA
Study Director: Sergio Varini, MD Fundacion GESICA
Study Director: Daniel Nul, MD Fundacion GESICA
Study Director: Alejandro Macchia, MD Fundacion GESICA