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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Fundacion GESICA.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Fundacion GESICA
ClinicalTrials.gov Identifier:
NCT00597220
First received: January 8, 2008
Last updated: June 21, 2011
Last verified: June 2011
History of Changes

January 8, 2008
June 21, 2011
January 2008
July 2011   (final data collection date for primary outcome measure)
Survival free of atrial fibrillation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00597220 on ClinicalTrials.gov Archive Site
  • Number of patients in sinus rhythm at the time of each study visit [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of hospitalizations for CV reasons [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of all-cause hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of TE events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of patients who die or with non-fatal thromboembolic events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation
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.

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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Atrial Fibrillation
  • Dietary Supplement: Omega 3 (n-3 PUFA)
    1 gram of n-3 PUFA containing DHA and EPA
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Omega 3
    Intervention: Dietary Supplement: Omega 3 (n-3 PUFA)
  • Placebo Comparator: 2
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1600
August 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00597220
FORWARD
Yes
Alejandro Macchia, Fundacion GESICA
Fundacion GESICA
Not Provided
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
Fundacion GESICA
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP