Cohort description
deaths, death
ADVERSE EVENTS
The DIGIT-HF trial is a multicenter, randomized, double-blind, placebo-controlled investigator initiated clinical trial designed to demonstrate the efficacy of digitoxin in patients with HFrEF. Details on the design of the DIGIT-HF trial have been provided elsewhere [The current analyses are based on 901 patients, who had been randomized to digitoxin or placebo in the DIGIT-HF trial prior to March 2021. For the analysis in this manuscript, only patients having an available digitoxin level and a dose adaptation at week 6 could be analyzed. Therefore, patients which have been randomized to placebo or had no available digitoxin level and dose adaptation at week 6 for different reasons (death, adverse or serious adverse events leading to exclusion for further study participation, exclusion due to decision of the principal investigator, withdrawal of informed consent, lost to follow-up, other or unknown (not documented) reasons, undetectable digitoxin level due to potential compliance problems) were excluded from this analysis. Finally, 394 patients randomized to digitoxin with available digitoxin levels and dose adaptations at week 6 could be used for the present analysis. A total of 221 patients (56%) maintained a starting dose of 0.07 mg o.d. In 160 patients (41%), the digitoxin dose was reduced from 0.07 mg to 0.05 mg o.d. In 13 (3%) patients, the digitoxin dose was increased from 0.07 mg to 0.1 mg o.d. Patients up-titrated from 0.07 mg to 0.1 mg digitoxin o.d. were excluded, yielding a total of 381 patients suitable for this analysis (i.e., allocation to the digitoxin arm and continuation or reduction of digitoxin starting dose based on digitoxin serum concentrations measured at visit 1). These patients were split into a derivation set (Overview of selection of analysis population. * including deaths, adverse or serious adverse events leading to exclusion for further study participation, exclusion due to decision of the principal investigator, withdrawal of informed consent, lost to follow-ups, other or unknown (not documented) reasons