Chronic use of digitalis for mild-to-moderate heart failure did not alter systolic function compared to placebo, but was associated with a lower increase in diuretic use (18% vs 78%, P=0.004).
RCT (n=80)
Double-blind
Yes
BACKGROUND: Short- and intermediate-term use of cardiac glycosides promotes inotropy and improves the ejection fraction in systolic heart failure. AIM: To determine whether chronic digitalization alters left ventricular function and performance. METHODS: Eighty patients with mild-to-moderate systolic heart failure (baseline ejection fraction < or =45%) participated from our institution in a multi-center, chronic, randomized, double-blind study of digitalis vs. placebo. Of the 40 survivors, 38 (20 allocated to the digitalis arm and 18 to the placebo arm) were evaluated at the end of follow-up (mean, 48.4 months). Left ventricular systolic function was assessed by both nuclear ventriculography and echocardiography. The ejection fraction was measured scintigraphically, while the ventricular volumes were computed echocardiographically. RESULTS: The groups did not differ, at baseline or end-of-study, with respect to the ejection fraction and the loading conditions (arterial pressure, ventricular volumes and heart rate) by either intention-to-treat or actual-treatment-received analysis. Over the course of the trial, the digitalis arm exhibited no significant increase in the use of diuretics (18%, P=0.33), in distinction from the placebo group (78%, P=0.004), and a longer stay on study drug among those patients who withdrew from double-blind treatment (28.6 vs. 11.4 months, P=0.01). CONCLUSION: Following chronic use of digitalis for mild-to-moderate heart failure, cross-sectional comparison with a control group from the same inception cohort showed no appreciable difference in systolic function or performance. Thus, the suggested clinical benefit cannot be explained by an inotropic effect.
Hassapoyannes et al. (Mon,) conducted a rct in Mild-to-moderate systolic heart failure (n=80). Digitalis vs. Placebo was evaluated on Left ventricular systolic function (ejection fraction and loading conditions). Chronic use of digitalis for mild-to-moderate heart failure did not alter systolic function compared to placebo, but was associated with a lower increase in diuretic use (18% vs 78%, P=0.004).