Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation (FORWARD)
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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 |
- Survival free of atrial fibrillation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- 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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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 | |
Hospital Privado de la Comunidad | |
Mar del Plata, Buenos Aires, Argentina | |
Clinica y Maternidad Colon | |
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 |
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 |
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 17, 2012