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

June 21, 2011 updated by: Fundacion GESICA

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

1600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina
        • CEMIC (Centro de Educación Médica e Investigaciones Clinicas Norberto Quirno)
      • Cordoba, Argentina
        • Clinica Romagosa
      • Corrientes, Argentina
        • Hospital José de San Martín
      • Misiones, Argentina
        • Sanatorio Integral IOT
      • Salta, Argentina
        • Centro Cardiovascular Salta
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1118
        • Hospital Aleman
      • Caba, Buenos Aires, Argentina
        • Clínica Constituyentes
      • Caba, Buenos Aires, Argentina
        • Complejo Medico Policial Churruca Visca
      • Caba, Buenos Aires, Argentina
        • Fundacion Favaloro
      • Lanus, Buenos Aires, Argentina
        • Hospital Evita Pueblo FEDITEC
      • Mar del Plata, Buenos Aires, Argentina
        • Clinica y Maternidad Colon
      • Mar del Plata, Buenos Aires, Argentina
        • Hospital Privado de la Comunidad
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Sanatorio Parque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival free of atrial fibrillation
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients in sinus rhythm at the time of each study visit
Time Frame: 12 months
12 months
Number of hospitalizations for CV reasons
Time Frame: 12 months
12 months
Number of all-cause hospitalizations
Time Frame: 12 months
12 months
Incidence of TE events
Time Frame: 12 months
12 months
Number of patients who die or with non-fatal thromboembolic events
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion GESICA

Investigators

  • Study Chair: Hernan C Doval, MD, Fundación GESICA
  • Study Chair: Gianni Tognoni, MD, Mario Negri Institute
  • Study Director: Hugo Grancelli, MD, Fundación GESICA
  • Study Director: Sergio Varini, MD, Fundación GESICA
  • Study Director: Daniel Nul, MD, Fundación GESICA
  • Study Director: Alejandro Macchia, MD, Fundación GESICA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 17, 2008

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FORWARD (Allergan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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