Methods |
Three‐ to five‐yr (mean follow‐up 37 mo) multicenter parallel trial; primary endpoint—mortality; secondary endpoint—hospitalization for HF |
Participants |
6800 pts with EF ≤ 0.45 in main trial; mean age 63; 88% male; 54% Class II, 31% Class III; 82% on diuretics, 94% on ACEI; EF 0.29 & 0.28 (dig & pla); median duration of HF 17 & 16 mo (dig & pla); prior dig Rx in 44%; dx—71% ischemic, 15% idiopathic. Note: ancillary trial carried out in 988 additional pts with EF > 0.45 |
Interventions |
dig dosage at investigators' discretion; median baseline dosage in main trial of 0.25 mg/d |
Outcomes |
main trial mortality, dig versus pla: overall 34.8% & 35.1% (P value 0.80), from "worsening heart failure" 11.6% & 13.2% (P value 0.06), from "other cardiac" 15.0% & 13.0% (P value 0.04); main trial hospitalization, dig versus pla: 26.8% & 34.7% (P < 0.001); ancillary trial mortality 23.4% in both groups |
Notes |
blind allocation—yes
blinded to outcomes—?
baselines comparable—yes
main trial loss to follow‐up—1.4%
dig titrated to level—no |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Low risk |
A—Adequate |