Bavendiek, Udo and Grosshennig, Anika and Schwab, Johannes and Berliner, Dominik and Rieth, Andreas and Maier, Lars S. and Gaspar, Thomas and Thomas, Nele Henrike and Liu, Xiaofei and Schallhorn, Sven and Angelini, Eleonora and Soltani, Samira and Rathje, Fabian and Sandu, Mircea-Andrei and Geller, Welf and Hambrecht, Rainer and Zdravkovic, Marija and Philipp, Sebastian and Kosevic, Dragana and Nickenig, Georg and Scheiber, Daniel and Winkler, Sebastian and Becher, Peter Moritz and Lurz, Philipp and Hulsmann, Martin and Wiesner, Soren and Schroeder, Christoph and Neuhaus, Barbara and Seltmann, Anika and von der Leyen, Heiko and Veltmann, Christian and Stork, Stefan and Bohm, Michael and Koch, Armin and Bauersachs, Johann (2025) Digitoxin in Patients with Heart Failure and Reduced Ejection Fraction. NEW ENGLAND JOURNAL OF MEDICINE, 393 (12). pp. 1155-1165. ISSN 0028-4793, 1533-4406
Full text not available from this repository. (Request a copy)Abstract
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.) In patients with heart failure and reduced ejection fraction who were receiving guideline-directed medical therapy, digitoxin lowered the risk of death or hospitalization for heart failure as compared with placebo.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | SERUM DIGOXIN CONCENTRATION; DIGITALIS GLYCOSIDES; MORTALITY; ASSOCIATION; GUIDELINES; MORBIDITY; DIAGNOSIS; TRIAL; ESC; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 26 Mar 2026 10:34 |
| Last Modified: | 26 Mar 2026 10:34 |
| URI: | https://pred.uni-regensburg.de/id/eprint/68000 |
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