Bardy 2005–SCD‐HeFT.

Study characteristics
Methods	Multicentre randomised controlled trial Setting: Patients with stable heart failure due to ischemic or nonischemic causes and a left ventricular ejection fraction of no more than 35 percent Country: United States & Canada
Participants	N = 1692 (845 amiodarone, 847 placebo) Sex: 76‐77% male Age: median 60 years Inclusion: heart failure with LVEF < 35% (primary prevention)
Interventions	Group 1: ICD (not analysed) Group 2: amiodarone (up to 800 mg/day initially, 300 mg/d on average at the end of the study) Group 3: placebo Duration: 2 to 5 years
Outcomes	All‐cause mortality, cardiac mortality, SCD, quality of life
Notes	The outcome 'quality of life was published in a separate report by Marks et al.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The trial was randomised, but the mechanism wasn't described in detail.
Allocation concealment (selection bias)	Unclear risk	The trial was randomised, but the mechanism wasn't described in detail.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Placebo and amiodarone were administered in a double‐blind fashion with the use of identical appearing 200‐mg tablets. . ."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Placebo and amiodarone were administered in a double‐blind fashion with the use of identical appearing 200‐mg tablets. . ."
Incomplete outcome data (attrition bias) Objective outcomes (death)	Low risk	Quote: "Pairwise comparisons of amiodarone with placebo and ICD with placebo were performed according to the intention‐to‐treat principle."
Incomplete outcome data (attrition bias) Subjective outcomes (quality of life)	Low risk	Quote: "Of 2521 patients who underwent randomisation, 2479 (98%) completed quality‐of‐life questionnaires at baseline. . . Overall, from a total of 9171 expected contacts with patients, 8747 quality‐of‐life questionnaires (95%) were collected. Only 1.2% of patients declined to complete the questionnaires, and only 1.4% of forms were judged to be incomplete."
Selective reporting (reporting bias)	Low risk	The study protocol was not available, but it is clear that the published report includes all expected outcomes.
Other bias	Low risk	The study appears to be free of other sources of bias.