Bavendiek, Udo and Thomas, Nele Henrike and Berliner, Dominik and Liu, Xiaofei and Schwab, Johannes and Rieth, Andreas and Maier, Lars S. and Schallhorn, Sven and Angelini, Eleonora and Soltani, Samira and Rathje, Fabian and Sandu, Mircea-Andrei and Geller, Welf and Gaspar, Thomas 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 von Karpowitz, Maria and Schroeder, Christoph and Neuhaus, Barbara and Seltmann, Anika and von Der Leyen, Heiko and Veltmann, Christian and Stoerk, Stefan and Boehm, Michael and Koch, Armin and Grosshennig, Anika and Bauersachs, Johann and DIGIT-HF Study Grp, (2025) DIGitoxin to Improve ou T comes in patients with advanced chronic Heart Failure (DIGIT-HF): Baseline characteristics compared to recent randomized controlled heart failure trials. EUROPEAN JOURNAL OF HEART FAILURE, 27 (7). pp. 1224-1233. ISSN 1388-9842, 1879-0844
Full text not available from this repository. (Request a copy)Abstract
AimsThis report presents the baseline characteristics of patients enrolled in the DIGIT-HF trial and compares them with participants from recent trials with improved outcomes in patients with heart failure (HF) and a reduced ejection fraction (HFrEF). Methods and resultsDIGIT-HF, a randomized, double-blind, placebo-controlled, multicentre trial enrolling patients with symptomatic HFrEF (New York Heart Association [NYHA] functional class II and left ventricular ejection fraction [LVEF] <= 30%, or NYHA class III-IV and LVEF <= 40%), compares the efficacy and safety of digitoxin versus placebo in addition to standard treatment. Most baseline characteristics of the intention-to-treat population (1212 patients, mean age 66 +/- 11 years, 20% women, mean LVEF 29 +/- 7%) were similar to those in recent HFrEF trials. The distribution of NYHA class II, III, and IV was 30%, 66% and 4%, respectively, and indicates that the patients were sicker than in comparator HFrEF trials. Less patients had atrial fibrillation (27%) than those in recent HFrEF trials, but prescription rates of background therapy with beta-blockers (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (95%), mineralocorticoid receptor antagonists (76%), and diuretics (87%) were high and similar. Overall, 40% of patients were on angiotensin receptor-neprilysin inhibitors, 19% on sodium-glucose cotransporter 2 inhibitors, and 9% on ivabradine. Rates of implantable cardioverter-defibrillator (ICD, 64%) and cardiac resynchronization therapy (CRT, 25%) devices were much higher than in recent HFrEF trials. ConclusionsPatients included in DIGIT-HF display a more severe HF symptom burden and higher rates of ICD/CRT implants compared to participants in recent HFrEF trials, while pharmacotherapy was largely similar. Clinical Trial Registration: EudraCT (2013-005326-38). ConclusionsPatients included in DIGIT-HF display a more severe HF symptom burden and higher rates of ICD/CRT implants compared to participants in recent HFrEF trials, while pharmacotherapy was largely similar. Clinical Trial Registration: EudraCT (2013-005326-38).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | SERUM DIGOXIN CONCENTRATION; MORTALITY; METAANALYSIS; ASSOCIATION; GLYCOSIDES; MORBIDITY; Heart failure; HFrEF; Cardiac glycosides; Digitoxin; Randomized clinical trial |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 27 Mar 2026 05:35 |
| Last Modified: | 27 Mar 2026 05:35 |
| URI: | https://pred.uni-regensburg.de/id/eprint/67966 |
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