Heart failure with reduced ejection fraction (HFrEF) continues to represent a clinical challenge despite advances in pharmacological optimization and device use. The DIGIT-HF trial evaluated whether the addition of digitoxin could improve clinical outcomes in this population.
This was a multicenter, randomized, double-blind, placebo-controlled trial that included 1,240 patients with symptomatic HFrEF (NYHA II–IV, LVEF ≤40%) under optimal standard treatment. The primary endpoint was a composite of all-cause mortality and heart failure hospitalization.
Results showed that digitoxin reduced the primary endpoint by 18% (HR 0.82; 95% CI 0.69–0.98; p=0.03), with an absolute risk reduction of 4.6% (NNT=22). The benefit was consistent across all prespecified subgroups, with no relevant safety concerns.
The authors concluded that digitoxin represents a safe and effective therapeutic alternative to improve prognosis in HFrEF patients, with inclusion criteria that are easily applicable to daily clinical practice.
Presented by Udo Bavendiek in Major Late Breaking Trials, ESC 2025, Madrid, Spain.
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