Bavendiek, Udo and Berliner, Dominik and Davila, Lukas Aguirre and Schwab, Johannes and Maier, Lars and Philipp, Sebastian A. and Rieth, Andreas and Westenfeld, Ralf and Piorkowski, Christopher and Weber, Kristina and Haenselmann, Anja and Oldhafer, Maximiliane and Schallhorn, Sven and von Der Leyen, Heiko and Schroeder, Christoph and Veltmann, Christian and Stoerk, Stefan and Boehm, Michael and Koch, Armin and Bauersachs, Johann and Tebbe, Ulrich and von Haehling, Stephan and Haass, Markus and Anker, Stefan and Mohacsi, Paul and Polzl, Gerhard and Trampisch, Helmut and Zimmermann, Silke and Neuhaus, Barbara (2019) Rationale and design of the DIGIT-HF trial (DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure): a randomized, double-blind, placebo-controlled study. EUROPEAN JOURNAL OF HEART FAILURE, 21 (5). pp. 676-684. ISSN 1388-9842, 1879-0844
Full text not available from this repository. (Request a copy)Abstract
Aims Despite recent advances in the treatment of chronic heart failure (HF), mortality and hospitalizations still remain high. Additional therapies to improve mortality and morbidity are urgently needed. The efficacy of cardiac glycosides - although regularly used for HF treatment - remains unclear. DIGIT-HF was designed to demonstrate that digitoxin on top of standard of care treatment improves mortality and morbidity in patients with HF and a reduced ejection fraction (HFrEF). Methods Patients with chronic HF, New York Heart Association (NYHA) functional class III-IV and left ventricular ejection fraction (LVEF) <= 40%, or patients in NYHA functional class II and LVEF <= 30% are randomized 1: 1 in a double-blind fashion to treatment with digitoxin (target serum concentration 8-18 ng/mL) or matching placebo. Randomization is stratified by centre, sex, NYHA functional class (II, III, or IV), atrial fibrillation, and treatment with cardiac glycosides at baseline. A total of 2190 eligible patients will be included in this clinical trial (1095 per group). All patients receive standard of care treatment recommended by expert guidelines upon discretion of the treating physician. The primary outcome is a composite of all-cause mortality or hospital admission for worsening HF (whatever occurs first). Key secondary endpoints are all-cause mortality, hospital admission for worsening HF, and recurrent hospital admission for worsening HF. Conclusion The DIGIT-HF trial will provide important evidence, whether the cardiac glycoside digitoxin reduces the risk for all-cause mortality and/or hospital admission for worsening HF in patients with advanced chronic HFrEF on top of standard of care treatment.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DIGOXIN; MORTALITY; HOSPITALIZATION; ASSOCIATION; ENALAPRIL; SURVIVAL; GUIDELINES; WITHDRAWAL; REDUCTION; INSIGHTS; Heart failure; Cardiac glycosides; Digitalis; Digitoxin; Clinical trial |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 09 Apr 2020 05:51 |
| Last Modified: | 09 Apr 2020 05:51 |
| URI: | https://pred.uni-regensburg.de/id/eprint/27049 |
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