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

Fundacion GESICA

Status and phase

Unknown

Phase 3

Conditions

Atrial Fibrillation

Treatments

Dietary Supplement: Omega 3 (n-3 PUFA)

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00597220

FORWARD

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,600 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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