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
  Purpose

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 Intervention Phase
Atrial Fibrillation
Dietary Supplement: Omega 3 (n-3 PUFA)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Fundacion GESICA:

Primary Outcome Measures:
  • Survival free of atrial fibrillation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1600
Study Start Date: January 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597220

Locations
Argentina
Hospital Alemán
Caba, Buenos Aires, Argentina, 1118
Fundacion Favaloro
Caba, Buenos Aires, Argentina
Clinica Constituyentes
Caba, Buenos Aires, Argentina
Complejo Medico Policial Churruca Visca
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
Investigators
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
  More Information

No publications provided by Fundacion GESICA

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alejandro Macchia, Fundacion GESICA
ClinicalTrials.gov Identifier: NCT00597220     History of Changes
Other Study ID Numbers: FORWARD
Study First Received: January 8, 2008
Last Updated: June 21, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 02, 2014