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

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.