| Methods |
12‐wk multicenter withdrawal trial; primary endpoint—ET, six‐minute walk test; secondary endpoints—QOL, "heart failure score," global evaluation of progress, LVED, EF |
| Participants |
88 pts; mean age 64; 85% male; 83% Class II or III; 100% on diuretics, none on ACEI or beta‐blockers; mean EF 0.28; mean duration of HF 3.3 yrs; prior dig Rx in 100%; dx—64% ischemic, 36% cardiomyopathic; valvular disease excluded |
| Interventions |
dig dosage titrated to mean serum level of 1.2 ng/mL, median digoxin dosage 0.375 mg/d |
| Outcomes |
for dig versus pla, median ET change +1% & ‐18% (P value 0.003); no significant difference in six‐minute walk test, QOL profile, "heart failure score," global evaluation of progress, LVED; EF +7% for dig & ‐10% for pla (P value 0.016) |
| Notes |
blind allocation—yes
blinded to outcomes—yes
baselines comparable—yes
loss to follow‐up—1.1%
dig titrated to level—yes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A—Adequate |
