Evaluating the Effectiveness of Fish Oil Supplements at Reducing the Recurrence of Atrial Fibrillation

NCT00552084 ↗

Phase 4 Completed 190 enrolled Vanderbilt University GlaxoSmithKline · collab National Heart, Lung, and Blood Institute (NHLBI) · collab eCardio Diagnostics · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Atrial fibrillation (AF) is a heart rhythm disorder that usually involves a rapid heart rate. People who take fish oil supplements may reduce the risk of a recurrence of AF. This study will evaluate the effectiveness of fish oil at decreasing the recurrence of AF and will examine the reasons why fish oil may reduce this risk.

Timeline

Start: 2007-11
Primary completion: 2014-04
Completion: 2014-04

Outcome

Missed primary endpoint

paper time to recurrence of AF did not differ significantly in the 2 groups (hazard ratio 1.20; 95% confidence interval 0.76 to 1.90, adjusted p = 0.438). PMID 25465932 ↗

release “did not reduce the recurrence of symptomatic atrial fibrillation (AF) among patients with symptomatic paroxysmal AF or persistent AF” gsk.com ↗

Publications

Vanderbilt C, Free M, Li J, Gebretsadik T, Bian A, Shintani A, McBride BF, Solus J, Milne G, Crossley GH, Thompson D, Vidaillet H, Okafor H, Darbar D, Murray KT, Stein CM. Effect of omega-three polyunsaturated fatty acids on inflammation, oxidative stress, and recurrence of atrial fibrillation. Am J Cardiol. 2015 Jan 15;115(2):196-201. doi: 10.1016/j.amjcard.2014.10.022. Epub 2014 Oct 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fish oil	Other / unclassified	4 g	Oral