Dokumentenart: | Artikel | ||||
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Titel eines Journals oder einer Zeitschrift: | European Journal of Heart Failure | ||||
Verlag: | Wiley | ||||
Ort der Veröffentlichung: | HOBOKEN | ||||
Band: | 21 | ||||
Nummer des Zeitschriftenheftes oder des Kapitels: | 5 | ||||
Seitenbereich: | S. 676-684 | ||||
Datum: | 2019 | ||||
Institutionen: | Medizin > Lehrstuhl für Innere Medizin II | ||||
Identifikationsnummer: |
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Stichwörter / Keywords: | DIGOXIN; MORTALITY; HOSPITALIZATION; ASSOCIATION; ENALAPRIL; SURVIVAL; GUIDELINES; WITHDRAWAL; REDUCTION; INSIGHTS; Heart failure; Cardiac glycosides; Digitalis; Digitoxin; Clinical trial | ||||
Dewey-Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin | ||||
Status: | Veröffentlicht | ||||
Begutachtet: | Ja, diese Version wurde begutachtet | ||||
An der Universität Regensburg entstanden: | Ja | ||||
Dokumenten-ID: | 48691 |
Zusammenfassung
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 ...
Zusammenfassung
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.
Metadaten zuletzt geändert: 03 Sep 2021 10:02