Effects of an outpatient intervention comprising nurse-led non-invasive assessments, telemedicine support and remote cardiologists' decisions in patients with heart failure (AMULET Study): a randomised controlled trial.

Aim Prevention of heart failure (HF) hospitalisations and deaths constitutes a major therapeutic aim in patients with HF. The role of telemedicine in this context remains equivocal. We investigated whether an outpatient telecare based on nurse-led non-invasive assessments supporting remote therapeutic decisions (AMULET telecare) could improve clinical outcomes in patients after an episode of acute HF during the12-month follow-up. Methods and results In this prospective randomised controlled trial, patients with HF and left ventricular ejection fraction (LVEF) ≤49%, after an episode of acute HF within recent 6 months, were randomly assigned to receive either an outpatient telecare based on nurse-led non-invasive assessments (n = 300) (AMULET model) or standard care (n = 305). The primary outcome, being a composite of unplanned HF hospitalisation or cardiovascular death, occurred in 51 (17.1%) patients in the telecare group and 73 (23.9%) patients in the standard care group up to 12 months after randomization (HR: 0.69, 95% CI: 0.48-0.99, p = 0.044). The implementation of AMULET telecare, as compared to the standard care, reduced the risk of first unplanned HF hospitalisation (HR: 0.62; 95% CI: 0.42-0.91, p = 0.015) as well as the risk of total unplanned HF hospitalisations (HR: 0.64, 95% CI: 0.41-0.99, p = 0.044).There was no difference in cardiovascular mortality between the study groups (HR: 1.03, 95% CI: 0.54-1.67, p = 0.930). Conclusion AMULET telecare as compared to standard care significantly reduced the risk of HF hospitalisation or cardiovascular death during the 12-month follow-up among patients with HF and LVEF≤49% after an episode of acute HF (ClinicalTrials.gov: NCT03476590).