The beneficial effects of adherence to outpatient telecare intervention on clinical outcomes after an episode of acute heart failure: insights from the prospective randomised controlled AMULET trial

Abstract Background The prevention of hospitalisations and deaths is a major therapeutic aim in patients with heart failure (HF). In our previously published prospective randomised controlled trial, we demonstrated that an outpatient intervention comprising nurse-led non-invasive assessments, telemedicine support and remote cardiologist decision-making (AMULET telecare) reduced the risk of HF hospitalisation or cardiovascular death by 31% during the 12-month follow-up in HF patients after an episode of acute HF. Purpose To present the results of the prespecified per-protocol analysis of the AMULET trial that reveal the impact of AMULET telecare adherence on the prognosis of patients. Methods Patients with HF and left ventricular ejection fraction (LVEF) ≤49% and who experienced an episode of acute HF in the past 6 months were randomly assigned to receive either AMULET telecare (n=298) or standard care (n=305). Those who completed the predefined schedule of AMULET telecare (n=190) and all standard care patients were included in the per-protocol population. Results In this per-protocol analysis, when compared to standard care, the implementation of AMULET telecare reduced the risk of the primary outcome, a composite of unplanned HF hospitalisation or cardiovascular death (by 51%), and the following secondary outcomes: first unplanned HF hospitalisation, first unplanned cardiovascular hospitalisation, first all-cause unplanned hospitalisation, total unplanned HF hospitalisations and the number of days lost due to HF hospitalisations or death. There was no statistically significant difference in cardiovascular mortality, mortality due to HF and overall mortality between the study groups (Table). Conclusions Adherence to AMULET telecare enhances the positive effects of this intervention on the prognosis of HF patients with an LVEF≤49% after an episode of acute HF.