Nodari 2011 HF

Methods	RCT, parallel, (DHA + EPA vs MUFA), 12 months Summary risk of bias: moderate or high
Participants	People with heart failure (non‐ischaemic dilated cardiomyopathy) N: 67 intervention, 66 control. (analysed, intervention: 67 control: 66) Level of risk for CVD: high Men: 95.5% intervention, 84.9% control Mean age in years (SD): 61 (11) intervention, 64 (9) control Age range: not reported (18‐75 inclusion criteria) Smokers: not reported Hypertension: not reported Medications taken by at least 50% of those in the control group: beta‐blockers, ACE inhibitors, furosemide, amiodarone, aldosterone blockers Medications taken by 20%‐49% of those in the control group: not reported Medications taken by some, but less than 20% of the control group: statins, ARB Location: Italy Ethnicity: not reported
Interventions	Type: supplement (Omacor) Comparison: EPA + DHA vs MUFA Intervention: 2 × 1 g/d Omacor (1.7 g/d EPA + DHA at a ratio of 0.9 to 1.5) Control: 2 × 1 g/d olive oil (gelatin capsules identical in appearance to Omacor) Compliance: pill counts – participants were withdrawn if < 80% capsules taken (none were withdrawn). Fatty acid EPA + DHA 0.83% in intervention group, 0.41% in control group. Duration of intervention: 12 months
Outcomes	Main study outcome: left ventricular function and functional capacity Dropouts: 0 intervention, 0 control Available outcomes: mortality (nil death), combined CVD events, AF, BMI, hospitalisation for cardiovascular reasons, hospitalisation for worsening heart failure, lipids, blood glucose (but too different at baseline to use), serum cytokine Response to contact: yes
Notes	Study funding: Centro per lo Studio ed il Trattamento dello Scompenso Cardiaco, one author was a consultant for 8 pharmaceutical companies
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomised"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Paper states that placebo and verum were identical and that the study was double blind, but blinding of participants not checked. Author confirmed investigators not blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Author confirmed assessors not blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear whether all participants were assessed for all outcomes (e.g. hospitalisation), but some outcomes report no attrition
Selective reporting (reporting bias)	Unclear risk	NCT01223703 – study registration October 2010, recruitment November 2007 to June 2009. Retrospective
Attention	Low risk	No suggestion of this, and investigators appeared blinded (so could not differ in attention provided by allocation)
Compliance	Low risk	See characteristics table
Other bias	Low risk	None noted