{"id":"23ec27b0ec8d","type":"article","url":"https://hartvaat.nl/2025/09/25/digitoxine-bij-hfref-gerandomiseerde-trial-nejm/","title":"Digitoxine bij HFrEF: gerandomiseerde trial — NEJM","title_en":"Digitoxin in Patients with Heart Failure and Reduced Ejection Fraction.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","internist"],"tags":["dapa-hf","step-hfpef"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2415471","source_url":"https://doi.org/10.1056/NEJMoa2415471","authors":["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 Zdravkovic","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"],"significance":9,"published":"2025-09-25","source_date":"2025-09-25","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfref-hartfalen-met-verminderde-ejectie/","https://hartvaat.nl/kennis/hartfalen/hfmref-hartfalen-met-matig-verminderde-ejectie/"],"congress":"","summary_en":"This NEJM trial showed that digitoxin reduced heart failure hospitalization in patients with HFrEF receiving contemporary guideline-directed medical therapy. The result repositions cardiac glycosides as a useful adjunct in the modern era of quadruple therapy for heart failure.","created":"2026-07-03T10:31:53Z","updated":"2026-07-03T13:30:52Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM-trial onderzocht digitoxine bij HFrEF in het moderne GDMT-tijdperk. Het hartglycoside verminderde hartfalenhospitalisaties, wat digitalis herpositioneert als additionele therapie bij geselecteerde HFrEF-patiënten.","abstract_original":"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 heart failure occurred in 172 patients (28.1%) in the digitoxin group and 182 (30.4%) in the placebo group (hazard ratio, 0.85; 95% CI, 0.69 to 1.05). At least one serious adverse event occurred in 29 patients (4.7%) in the digitoxin group and 17 (2.8%) in the placebo group. CONCLUSIONS: Treatment with digitoxin led to a lower combined risk of death from any cause or hospital admission for worsening heart failure than placebo among patients with heart failure and reduced ejection fraction who received guideline-directed medical therapy. (Funded by the German Federal Ministry of Research, Technology, and Space and others; DIGIT-HF EudraCT number, 2013-005326-38.)."}