AIM of the AMULET project

Development of a new model of medical care with the use of modern methods of non-invasive clinical assessment and telemedicine in heart failure patients to improve their prognosis, availability of specialist care and to reduce the costs of healthcare.

RATIONALE

Treatment of patients with heart failure is a great challenge for contemporary medicine. The frequency of heart failure in the European population is assessed for 0.4-2%. High morbidity and mortality rate, poor quality of life and frequent hospitalizations characterize this disease. After an episode of acute decompensated heart failure, the rate of rehospitalisations is around 10% at 30 days, increasing at 40% within 6 months. The early diagnosis of fluid retention seems to be crucial in prevention of hospitalization. Hemodynamic stability reveals to be the most important clinical feature and congestion is the main cause of heart failure worsening. The difficulty in the objective assessment of fluid overload may be one of the reasons of insufficient decongestion in patients discharged from the hospital after acute heart failure decompensation. Thus, the heart failure patient is extremely vulnerable to hemodynamic collapse even within 90 days after discharge.

AMULET CONCEPT

AMULET project proposes an advanced telecare system, supported by individualized assessment, based on bioimpedance methods. We created ambulatory care points, operated by nurses under a remote supervision of cardiologists. The clinical data, including results from modern diagnostic devices (impedance cardiography monitor and body composition analyser), is automatically entered into an interactive system, accessible to a supervising cardiologist. Remote specialist recommendation is generated based on previously implemented decision algorithm.
This ambulatory stationary telecare system we be will completed with home monitoring devices to provide continuous control of the most vulnerable patients.

AMULET PROGRESS

The AMULET project was started in May 2017 and is planned to last till February 2021. Thefirst stage wasa pilot study which included 73 subjects (mean LVEF 29.6%), discharged from the hospital after heart failure decompensation. The results confirmed that detailed hemodynamic assessment improves identification of residual congestion and supports the optimization of pharmacotherapy.
The second stage was the multicenter, prospective, randomized (1:1), open-label and controlled, parallel group trial (ClinicalTrials.gov - NCT03476590), intended to compare AMULET intervention with standard care (600 patients, randomized 1:1). The recruitmentstarted in March 2018 and the results are expected at the end of 2020.