Digitoxin in Patients with Heart Failure and Reduced Ejection Fraction

作者：Udo Bavendiek, Anika Großhennig, Johannes Schwab, Dominik Berliner, Andreas Rieth, Lars S. Maier, Thomas Gaspar, Nele Henrike Thomas, Xiaofei Liu, Sven Schallhorn, Eleonora Angelini, Samira Soltani, Fabian Rathje, Mircea‐Andrei Sandu, Welf Geller, Rainer Hambrecht, Marija Zdravković, Sebastian Philipp, Dragana Kosevic, Georg Nickenig, Daniel Scheiber, Sebastian Winkler, Peter Moritz Becher, Philipp Lurz, Martin Hülsmann, Sören Wiesner, Christoph Schröder, Barbara Neuhaus, Anika Seltmann, Heiko von der Leyen, Christian Veltmann, Stefan Störk, Michael Böhm, Armin Koch, Johann Bauersachs · 发表于：New England Journal of Medicine · 年份：2025 · DOI：10.1056/nejmoa2415471 · 被引用次数：93 · 研究领域：Heart Failure Treatment and Management、Ion Transport and Channel Regulation、Cardiac electrophysiology and arrhythmias

BACKGROUND: The therapeutic efficacy of the cardiac glycoside digitoxin in patients with heart failure and reduced ejection fraction is not established. METHODS: In this international, double-blind, placebo-controlled trial, we randomly assigned patients with chronic heart failure who had a left ventricular ejection fraction of 40% or less and a New York Heart Association (NYHA) functional class of III or IV or a left ventricular ejection fraction of 30% or less and an NYHA functional class of II in a 1:1 ratio to receive digitoxin (at a starting dose of 0.07 mg once daily) or matching placebo in addition to guideline-directed medical therapy. The primary outcome was a composite of death from any cause or hospital admission for worsening heart failure, whichever occurred first. RESULTS: Among 1240 patients who underwent randomization, 1212 fulfilled the criteria for inclusion in the modified intention-to-treat population: 613 patients in the digitoxin group and 599 in the placebo group. Over a median follow-up of 36 months, a primary-outcome event occurred in 242 patients (39.5%) in the digitoxin group and 264 (44.1%) in the placebo group (hazard ratio for death or first hospital admission for worsening heart failure, 0.82; 95% confidence interval [CI], 0.69 to 0.98; P = 0.03). Death from any cause occurred in 167 patients (27.2%) in the digitoxin group and 177 (29.5%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.69 to 1.07). A first hospital admission for worsening he...