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

NCT00597220 | Unknown Phase 3 DMC

• 1 other identifier: FORWARD
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 13

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Survival free of atrial fibrillation

  12 months

Secondary Outcomes (5)

• Number of patients in sinus rhythm at the time of each study visit

  12 months

• Number of hospitalizations for CV reasons

  12 months

• Number of all-cause hospitalizations

  12 months

• Incidence of TE events

  12 months

• Number of patients who die or with non-fatal thromboembolic events

  12 months

Study Arms (2)

1

EXPERIMENTAL

Omega 3

Dietary Supplement: Omega 3 (n-3 PUFA)

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Omega 3 (n-3 PUFA) DIETARY_SUPPLEMENT

1 gram of n-3 PUFA containing DHA and EPA

1

Placebo DRUG

Placebo

2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent atrial fibrillation

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion GESICA: lead

Study Sites (13)

Hospital Alemán

Caba, Buenos Aires, 1118, Argentina

Location

Clinica Constituyentes

Caba, Buenos Aires, Argentina

Location

Complejo Medico Policial Churruca Visca

Caba, Buenos Aires, Argentina

Location

Fundacion Favaloro

Caba, Buenos Aires, Argentina

Location

Hospital Evita Pueblo FEDITEC

Lanús, Buenos Aires, Argentina

Location

Clinica y Maternidad Colon

Mar del Plata, Buenos Aires, Argentina

Location

Hospital Privado de la Comunidad

Mar del Plata, Buenos Aires, Argentina

Location

Hospital José de San Martín

Corrientes, Corrientes Province, Argentina

Location

Clinica Romagosa

Córdoba, Córdoba Province, Argentina

Location

Sanatorio Integral IOT

Misiones, Misiones Province, Argentina

Location

Centro Cardiovascular Salta

Salta, Salta Province, Argentina

Location

Sanatorio Parque

Rosario, Santa Fe Province, Argentina

Location

CEMIC (Centro de Educación Médica e Investigaciones Clinicas Norberto Quirno)

Buenos Aires, Argentina

Location

Related Publications (2)

• Macchia A, Grancelli H, Varini S, Nul D, Laffaye N, Mariani J, Ferrante D, Badra R, Figal J, Ramos S, Tognoni G, Doval HC; GESICA Investigators. Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) trial. J Am Coll Cardiol. 2013 Jan 29;61(4):463-468. doi: 10.1016/j.jacc.2012.11.021. Epub 2012 Dec 19.

  PMID: 23265344 DERIVED

• Macchia A, Varini S, Grancelli H, Nul D, Laffaye N, Ferrante D, Tognoni G, Doval HC; FORomegaARD investigators. The rationale and design of the FORomegaARD Trial: A randomized, double-blind, placebo-controlled, independent study to test the efficacy of n-3 PUFA for the maintenance of normal sinus rhythm in patients with previous atrial fibrillation. Am Heart J. 2009 Mar;157(3):423-7. doi: 10.1016/j.ahj.2008.10.027. Epub 2009 Jan 8.

  PMID: 19249410 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Docosahexaenoic Acids; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Hernan C Doval, MD

  Fundacion GESICA

  STUDY CHAIR

• Gianni Tognoni, MD

  Mario Negri Institute

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 22, 2011

Record last verified: 2011-06

Locations

AR (13)