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Assisted therapy optimizing module to improve physician adhErence with guideLine-directed medical heart failure therapy rationale and design of the AMPEL trial

  • Luca Brunelli
  • , Luiza Hoch
  • , Bernhard Erich Pfeifer
  • , Sabrina Neururer
  • , Elisabeth Kleinheinz
  • , Bettina Fetz
  • , Aaron Lauschensky
  • , Günter Schreier
  • , Robert Modre-Osprian
  • , Marc-Michael Zaruba
  • , Moritz Messner
  • , Maria Ungericht
  • , Markus Wallner
  • , Cosima Stark
  • , Stefan Pötz
  • , Bernadette Taucher
  • , Almut Frank
  • , Gerhard Pölzl
  • University Hospital for Internal Medicine III, Medical University Innsbruck
  • Central Institute of Clinical and Chemical Laboratory Diagnostics, University Hospital of Innsbruck
  • Institut für klinische Epidemiologie (IET), Tirol Kliniken GmbH
  • Division for Digital Health and Telemedicine, UMIT TIROL - Private University for Health Sciences and Technology
  • Tyrolean Federal Institute for Integrated Care, Tirol Kliniken GmbH
  • telbiomed
  • Division of Cardiology, Department of Internal Medicine, MedUni Graz
  • Department of Radiology, Division of Neuroradiology, Vascular and Interventional Radiology, Medical University of Graz
  • Steiermärkische Krankenanstaltengesellschaft m.b.H. (KAGes)
  • Medical Directorate, Styrian Hospitals Association

Research output: Contribution to journalArticlepeer-review

Abstract

Background
Guideline-directed medical therapy (GDMT) is very effective in the early, vulnerable phase after discharge following an acute heart failure (HF) event, but its widespread implementation in everyday clinical practice is limited.
AMPEL is a guideline-based decision support software service for physicians to improve adherence with GDMT. The four drug classes that make up the GDMT and the percentage of each prescribed dose in relation to the target dose according to the current ESC guidelines are displayed graphically. A daily update considers the current therapy as well as absolute or relative contraindications.

Methods and results
We present the rationale and protocol of the AMPEL trial, a multicenter randomized trial with a parallel-group design to investigate the effectiveness of the AMPEL service on GDMT implementation and patient clinical outcomes in a total of 260 patients. Salient features of the AMPEL study are that it is being conducted as part of the established disease management program (DMP) for HF, HerzMobil, and that participating physicians are given randomised access to the AMPEL service compared to the standard of care in the control group. The primary endpoint includes an implementation endpoint for assessment of the quality of indication- and dose-adjusted GDMT at 90 days and a clinical endpoint assessed with a stratified win ratio.

Conclusions
The AMPEL trial is a prospective, randomized trial investigating the effectiveness of a guideline-based decision support software service for physicians to improve adherence with GDMT in a telemedicine-assisted disease management program for patients with heart failure.

Graphical abstract
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Original languageEnglish
Article number101797
Number of pages7
JournalIJC Heart and Vasculature
Volume61
Early online date11 Sept 2025
DOIs
Publication statusPublished - Dec 2025

Research Field

  • Exploration of Digital Health

Keywords

  • HEART failure
  • GDMT (guideline-directed medical therapy)
  • Guideline-based decision support for physicians
  • Disease management program
  • Randomized controlled trial

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