TY  - JOUR
A1  - Bavendiek, Udo
A1  - Berliner, Dominik
A1  - Aguirre Dávila, Lukas
A1  - Schwab, Johannes
A1  - Maier, Lars
A1  - Philipp, Sebastian A.
A1  - Rieth, Andreas
A1  - Westenfeld, Ralf
A1  - Piorkowski, Christopher
A1  - Weber, Kristina
A1  - Hänselmann, Anja
A1  - Oldhafer, Maximiliane
A1  - Schallhorn, Sven
A1  - von der Leyen, Heiko
A1  - Schröder, Christoph
A1  - Veltmann, Christian
A1  - Störk, Stefan
A1  - Böhm, Michael
A1  - Koch, Armin
A1  - Bauersachs, Johann
T1  - 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
JF  - European Journal of Heart Failure
N2  - 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.
KW  - heart failure
KW  - cardiac glycosides
KW  - digitalis
KW  - digitoxin
KW  - clinical trial
Y1  - 2019
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-221548
VL  - 21
ER  - 
TY  - JOUR
A1  - Sommer, Kim K.
A1  - Amr, Ali
A1  - Bavendiek, Udo
A1  - Beierle, Felix
A1  - Brunecker, Peter
A1  - Dathe, Henning
A1  - Eils, Jürgen
A1  - Ertl, Maximilian
A1  - Fette, Georg
A1  - Gietzelt, Matthias
A1  - Heidecker, Bettina
A1  - Hellenkamp, Kristian
A1  - Heuschmann, Peter
A1  - Hoos, Jennifer D. E.
A1  - Kesztyüs, Tibor
A1  - Kerwagen, Fabian
A1  - Kindermann, Aljoscha
A1  - Krefting, Dagmar
A1  - Landmesser, Ulf
A1  - Marschollek, Michael
A1  - Meder, Benjamin
A1  - Merzweiler, Angela
A1  - Prasser, Fabian
A1  - Pryss, Rüdiger
A1  - Richter, Jendrik
A1  - Schneider, Philipp
A1  - Störk, Stefan
A1  - Dieterich, Christoph
T1  - Structured, harmonized, and interoperable integration of clinical routine data to compute heart failure risk scores
JF  - Life
N2  - Risk prediction in patients with heart failure (HF) is essential to improve the tailoring of preventive, diagnostic, and therapeutic strategies for the individual patient, and effectively use health care resources. Risk scores derived from controlled clinical studies can be used to calculate the risk of mortality and HF hospitalizations. However, these scores are poorly implemented into routine care, predominantly because their calculation requires considerable efforts in practice and necessary data often are not available in an interoperable format. In this work, we demonstrate the feasibility of a multi-site solution to derive and calculate two exemplary HF scores from clinical routine data (MAGGIC score with six continuous and eight categorical variables; Barcelona Bio-HF score with five continuous and six categorical variables). Within HiGHmed, a German Medical Informatics Initiative consortium, we implemented an interoperable solution, collecting a harmonized HF-phenotypic core data set (CDS) within the openEHR framework. Our approach minimizes the need for manual data entry by automatically retrieving data from primary systems. We show, across five participating medical centers, that the implemented structures to execute dedicated data queries, followed by harmonized data processing and score calculation, work well in practice. In summary, we demonstrated the feasibility of clinical routine data usage across multiple partner sites to compute HF risk scores. This solution can be extended to a large spectrum of applications in clinical care.
KW  - medical informatics initiative
KW  - HiGHmed
KW  - medical data integration center
KW  - clinical routine data
KW  - heart failure
KW  - risk prediction scores
KW  - semantic interoperability
KW  - openEHR
Y1  - 2022
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-275239
SN  - 2075-1729
VL  - 12
IS  - 5
ER  -