Effects of digoxin on electrocardiogram in patients with acute atrial fibrillation--a randomized, placebo-controlled study. Digitalis in Acute Atrial Fibrillation (DAAF) Trial Group.

BACKGROUND: Studies of healthy volunteers or patients in sinus rhythm have indicated that treatment with digoxin produces characteristic changes in the electrocardiogram (ECG). No randomized, placebo-controlled studies are available and no study has investigated the effect on ECG in patients with atrial fibrillation.

HYPOTHESIS: In a substudy to a trial comparing the therapeutic effect of intravenously administered digoxin with placebo in patients with acute atrial fibrillation, we investigated these effects as well as the relation between ECG changes and serum concentration of digoxin.

METHODS: In all, 167 patients were included. Standard ECGs recorded at baseline, and at 2, 6, 12, and 16 h after randomization were digitized, and changes in RR-intervals, QRS width, ST-segment amplitude at 60 ms after the J point, T-wave amplitude, and QTc interval were calculated. Furthermore, the correlation between the serum concentration of digoxin at 16 h after inclusion and changes on the ECG was analyzed.

RESULTS: Compared with placebo, digoxin resulted in an increase in RR-interval (p < 0.0001), a decrease in ST-segment and T-wave amplitude (p = 0.009 and p = 0.002, respectively), and in the QTc interval (p = 0.01). These changes were present 2 h after the first dose, but were more pronounced after 16 h. There was no significant correlation between serum concentration of digoxin and ECG changes at 16 h.

CONCLUSION: Compared with placebo, digoxin produces significant changes on ECG in patients with acute atrial fibrillation. The changes are in accordance with previous findings in individuals in sinus rhythm. There was no correlation between serum concentration of digoxin and ECG changes.