A cross-sectoral study to individually optimize therapy in heart failure- "AMPEL" trial

L. Brunelli, Günter Schreier, D. Hayn, K. Kreiner, A. Lauschensky, F. Wiesmüller, M. Baumgartner, B. Pfeifer, S. Neururer, A. Bauer, G. Poelzl

Publikation: Posterpräsentation ohne Beitrag in TagungsbandPosterpräsentation ohne Eintrag in TagungsbandBegutachtung


Guideline-directed medical treatment (GDMT) beyond the hospitalization phase is crucial for a stable course of the disease and better survival. Nevertheless, several studies show a clear need for optimization regarding both initiation and dosing of GDMT in the context of daily clinical practice. Several eforts have been made to improve adherence to the use of GDMT, but no signifcant results have been shown to date in terms of treatment optimization and clinical outcome.
The Assisted Therapy Optimizing Module has been designed to actively assist physicians in adhering to and improving guideline-based medical therapy in the context of a multidisciplinary heart failure management program.

The Assisted Therapy Optimizing module is a graphical visualization of the diferent drug classes and the percentage of each prescribed target dose according to the current guidelines for the treatment of chronic heart failure patients with reduced ejection fraction (HFrEF) published by the European Society of Cardiology. If a drug class or dose increase is contraindicated, the physicians can choose from a predefned selection of absolute or relative contraindications and document this in the system. To achieve a high level of GDMT consistency, the selection options are limited exclusively to the contraindications listed in the guidelines. listed in the guidelines. The time-limited contraindications are considered in the visualization and the underlying algorithm ensures that the diagram is immediately adapted to any change in medication and/or contraindications. We are planning a prospective, randomized, multi-sectoral single-centre study with parallel group design to test the hypothesis that our medical software enhances pharmacological guideline conformity. Permuted block randomisation occurs at the level of physicians within the management program. The primary endpoint of the study is the proportion of HFrEF patients who receive an individually optimized number and dose of GDMT 90 days after randomization. Optimization of GDMT including the four classes of medication recommended to reduce mortality and HF hospitalization (BB; RAASi; MRA, and SGLT2) will be evaluated by a scoring system.

Physician adherence to guideline-recommended treatment is calculated by dividing the actual treatment score for each substance by the theoretically possible treatment score. Secondary endpoints in this study will evaluate the clinical efects of the optimization in therapy including changes in vital parameters, renal function, electrolytes, NT-proBNP and quality of life at 3 months as well as rates of HF-hospitalization and death.176 patients will be monitored cautiously for  3 months during the management program. A follow-up after  6 months and 12 months will be performed. Conclusion: We are planning to demonstrate a 20% increase of GDMT based on the Assisted Terapy Optimizing Module. Following positive results, the software will be implemented in the comprehensive care program HerzmobilTirol. In the future, the software could be provided to other cardiologists to optimize GDMT.
PublikationsstatusVeröffentlicht - Mai 2023
VeranstaltungÖsterreichische Kardiologische Gesellschaft Jahrestagung 2023: „Wissenschaft und Praxis im Dialog“ - Salzburg-Congress, Salzburg, Österreich
Dauer: 31 Mai 20233 Juni 2023


KonferenzÖsterreichische Kardiologische Gesellschaft Jahrestagung 2023
KurztitelÖKG Jahrestagung 2023

Research Field

  • Exploration of Digital Health

Web of Science subject categories (JCR Impact Factors)

  • Medicine, General & Internal


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