Table 5.

Trials of Secondary Prevention of Outcomes in Patients With Heart Failure

Study, Author, Year	Trial Design, No. of Subjects, Duration	Patient Population	Intervention and Control	End Point Results (Primary End Point)	Strengths and Limitations
GISSI-HF Tavazzi et al12 2008	RCT n=6875 3.9 y	Inclusion criteria: patients with HF Exclusion criteria: acute coronary syndrome or revascularization within 1 mo; planned cardiac surgery within 3 mo; significant liver disease	Intervention: 840 mg/d EPA+DHA Comparator: placebo (olive oil)	Primary end points: Total mortality; 1969 events; RR, 0.91 (95% CI, 0.83–0.99) Total mortality or hospitalization for CVD; 4034 events; RR, 0.92 (95% CI, 0.85–0.99)	Strengths: large sample size, large numbers of events and statistical power, long duration of follow-up, patients on intensive modern medical therapy Limitations: fewer patients (9%) with HF with preserved ejection fraction; lack of information on background omega-3 PUFA intake

CI indicates confidence interval; CVD, cardiovascular disease; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; GISSI-HF, Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico–Heart Failure; HF, heart failure; PUFA, polyunsaturated fatty acid; RCT, randomized controlled trial; and RR, relative risk.