| Methods |
Three‐mo multicenter withdrawal trial; primary endpoints—clinical deterioration, ET, six‐minute walk test; secondary endpoints—symptoms, QOL, functional class, LVED, EF |
| Participants |
178 pts; mean age 60; 76% male; 73% Class II, 27% Class III; 100% on diuretics & ACEI; mean EF 0.27; prior dig Rx in 100%; dx—60% ischemic, 38% cardiomyopathic |
| Interventions |
dig dosage titrated to mean serum level of 1.2 ng/mL, mean dig dosage 0.38 mg/d |
| Outcomes |
for dig versus pla, ET 43 seconds greater (P value 0.033), six‐minute walk test 41 m further (P value 0.01), better self‐assessed symptoms (P value 0.007) & QOL profile (P value 0.04), less deterioration in class (10% vs 27%, P value 0.019); LVED ‐1.4% versus +3.0% (P value 0.04), EF ‐3.7% versus ‐13.3% (P value 0.001) |
| Notes |
blind allocation—yes
blinded to outcomes—yes
baselines comparable—yes
loss to follow‐up—1.7%
dig titrated to level—yes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A—Adequate |
