The rationale and design of the FORωARD 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

American Heart Journal

Volumn 157, Issue 3, 2009, Pages 423-427

  Macchia, Alejandro ^a   Varini, Sergio ^a   Grancelli, Hugo ^a   Nul, Daniel ^a   Laffaye, Nicolas ^a   Ferrante, Daniel ^a   Tognoni, Gianni ^b   Doval, Hernan C ^a  

^a GESICA (Grupo de Estudio en Investigacin Clnica en Argentina) Foundation   (Argentina)

^b Consorzio Mario Negri Sud ^*  (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

OMEGA 3 FATTY ACID;

ADULT; AGED; ANTIARRHYTHMIC ACTIVITY; ARTICLE; CARDIOVASCULAR RISK; CARDIOVERSION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DIETARY INTAKE; DRUG EFFICACY; FOLLOW UP; HEART ATRIUM FIBRILLATION; HUMAN; MEDICAL PRACTICE; NONHUMAN; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINUS RHYTHM; VITAMIN SUPPLEMENTATION; ARGENTINA; CLINICAL PROTOCOL; DOUBLE BLIND PROCEDURE; DRUG EFFECT; HEART MUSCLE CONDUCTION SYSTEM; METHODOLOGY; RECURRENT DISEASE; RESEARCH ETHICS;

ARGENTINA; ATRIAL FIBRILLATION; CLINICAL PROTOCOLS; DOUBLE-BLIND METHOD; ETHICS, RESEARCH; FATTY ACIDS, OMEGA-3; HEART CONDUCTION SYSTEM; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECURRENCE; RESEARCH DESIGN;

EID: 60649121936     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2008.10.027     Document Type: Article

References (32)

1. Doval H.C., Nul D.R., Grancelli H.O., et al. Randomised trial of low-dose amiodarone in severe congestive heart failure. Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiaca en Argentina (GESICA). Lancet 344 (1994) 493-498
2. GESICA Investigators. Randomised trial of telephone intervention in chronic heart failure: DIAL trial. BMJ 331 (2005) 425
3. GISSI-Hf Investigators. Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet (2008) 10.1016/S0140-6736(08)61239-8
4. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet 354 (1999) 447-455
5. Hohnloser S.H., Kuck K.H., and Lilienthal J. Rhythm or rate control in atrial fibrillation Pharmacological Intervention in Atrial Fibrillation (PIAF): a randomised trial. Lancet 356 (2000) 1789-1794
6. Wyse D.G., Waldo A.L., DiMarco J.P., et al. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med 347 (2002) 1825-1833
7. Carlsson J., Miketic S., Windeler J., et al. Randomized trial of rate-control versus rhythm-control in persistent atrial fibrillation: the Strategies of Treatment of Atrial Fibrillation (STAF) study. J Am Coll Cardiol 41 (2003) 1690-1696
8. Van Gelder I.C., Hagens V.E., Bosker H.A., et al. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med 347 (2002) 1834-1840
9. Opolski G., Torbicki A., Kosior D., et al. Rate control vs rhythm control in patients with nonvalvular persistent atrial fibrillation: the results of the Polish How to Treat Chronic Atrial Fibrillation (HOT CAFE) study. Chest 126 (2004) 476-486
10. Bialy D., Lehmann M.H., Schumacher D.N., et al. Hospitalization for arrhythmias in the United States: importance of atrial fibrillation. J Am Coll Cardiol 19 (1992) 41A
11. Benjamin E.J., Wolf P.A., D'Agostino R.B., et al. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation 98 (1998) 946-952
12. Flegel K.M., Shipley M.J., and Rose G. Risk of stroke in non-rheumatic atrial fibrillation. Lancet 1 (1987) 526-529
13. Wolf P.A., Abbott R.D., and Kannel W.B. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med 147 (1987) 1561-1564
14. Protheroe J., Fahey T., Montgomery A.A., et al. The impact of patients' preferences on the treatment of atrial fibrillation: observational study of patient based decision analysis. BMJ 320 (2000) 1380-1384
15. Wolf P., Mitchell J.B., Baker C.S., et al. Impact of atrial fibrillation on mortality, stroke and medical costs. Arch Intern Med 158 (1998) 229-234
16. de Denus S., Sanoski C.A., Carlsson J., et al. Rate vs rhythm control in patients with atrial fibrillation a meta-analysis. Arch Intern Med 165 (2005) 258-262
17. Singh B.N., Singh S.N., Reda D.J., et al. Amiodarone versus sotalol for atrial fibrillation. N Engl J Med 352 (2005) 1861-1872
18. Zimetbaum P. Amiodarone for atrial fibrillation. N Engl J Med 356 (2007) 935-941
19. Singh B.N., Connolly S.J., Crijns H.J.G.M., et al. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med 357 (2007) 987-999
20. Køber L., Torp-Pedersen C., McMurray J.J., et al. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med 358 (2008) 2678-2687
21. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines. Circulation 114 (2006) 700-752
22. Jordan H., Matthan N., Chung M., et al. Effects of omega-3 fatty acids on arrhythmogenic mechanisms in animal and isolated organ/cell culture studies. Evidence report/technology assessment No. 92 (Prepared by Tufts-New England Medical Center Evidence-based Practice Center, under Contract No. 290-02-0022). AHRQ Publication No 04-E011-2 (2004), Agency for Healthcare Research and Quality, Rockville, MD
23. Kromhout D., Bosschieter E.B., and de Lezenne Coulander C. The inverse relation between fish consumption and 20-year mortality from coronary heart disease. N Engl J Med 312 (1985) 1205-1209
24. Daviglus M.L., Stamler J., Orencia A.J., et al. Fish consumption and the 30-year risk of fatal myocardial infarction. N Engl J Med 336 (1997) 1046-1053
25. Hu F.B., Bronner L., Willett W.C., et al. Fish and omega-3 fatty acid intake and risk of coronary heart disease in women. JAMA 287 (2002) 1815-1821
26. Mozaffarian D., Lemaitre R.N., Kuller L.H., et al. Cardiovascular Health Study. Cardiac benefits of fish consumption may depend on the type of fish meal consumed: the Cardiovascular Health Study. Circulation 107 (2003) 1372-1377
27. He K., Song Y., Daviglus M.L., et al. Accumulated evidence on fish consumption and coronary heart disease mortality: a meta-analysis of cohort studies. Circulation 109 (2004) 2705-2711
28. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet 354 (1999) 447-455
29. Bucher H.C., Hengstler P., Schindler C., et al. N-3 polyunsaturated fatty acids in coronary heart disease: a meta-analysis of randomized controlled trials. Am J Med 112 (2002) 298-304
30. Jahangiri A., Leifert W.R., Patten G.S., et al. Termination of asynchronous contractile activity in rat atrial myocytes by n-3 polyunsaturated fatty acids. Mol Cell Biochem 206 (2000) 33-41
31. Mozaffarian D., Psaty B.M., Rimm E.B., et al. Fish intake and risk of incident atrial fibrillation. Circulation 110 (2004 27) 368-373
32. Calò L., Bianconi L., Colivicchi F., et al. N-3 fatty acids for the prevention of atrial fibrillation after coronary artery bypass surgery: a randomized, controlled trial. J Am Coll Cardiol 45 (2005) 1723-1728