Methods |
six‐mo multicenter parallel trial with third captopril arm; primary endpoint—ET; secondary endpoints—NYHA class, hospitalization, EF |
Participants |
196 pts; mean age 58; 83% male; 80% Class II; 87% on diuretics, none on beta‐blockers; mean EF 0.25; mean duration of HF 3.0 yrs; prior dig Rx in 68%; dx—61% ischemic, 31% cardiomyopathic |
Interventions |
dig dosage of 0.125 to 0.375 mg/d titrated to serum levels of 0.7 to 2.5 ng/mL |
Outcomes |
for dig versus pla, ET +10% & +6% (P value NS), EF +17% & +3% (P < 0.01); NYHA class improved in 31% of dig versus 22% of pla (P value NS) |
Notes |
blind allocation—yes
blinded to outcomes—?
baselines comparable—yes
loss to follow‐up—?
dig titrated to level—yes |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Low risk |
A—Adequate |