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

Sponsored by:	Fundacion GESICA
Information provided by:	Fundacion GESICA
ClinicalTrials.gov Identifier:	NCT00597220

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 III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
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

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 Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Omega 3	Dietary Supplement: Omega 3 (n-3 PUFA) 1 gram of n-3 PUFA containing DHA and EPA
2: Placebo Comparator	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

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

Contacts

Contact: Alejandro Macchia, MD

54119539606

macchia@negrisud.it

Locations

Argentina
CEMIC (Centro de Educación Médica e Investigaciones Clinicas Norberto Quirno)	Recruiting
Ciudad Autonoma de Buenos Aires, Argentina
Contact: Juan J Fuselli, MD 541145468200 ext 8258 jfuselli@cemic.edu.ar
Principal Investigator: Juan J Fuselli, MD

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

Responsible Party:	Fundacion GESICA ( Alejandro Macchia )
Study ID Numbers:	FORWARD
Study First Received:	January 8, 2008
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00597220 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009