Heart Failure Educational and Follow up Platform

Chronic heart failure (CHF) is a disease that has several specificities. It is both common and severe. This is a disease associated with high mortality and especially a high rate of hospitalization. These are partly due to the severity " per se "of the disease but also to the non optimal management of CHF and non-formal education of patients and their caregivers. Indeed, the majority of hospitalized patients shows some clinical signs of decompensation up to 5 days before hospitalization and could avoid to go to the emergency room and hospitalization by an adequate ambulatory reaction and care. It is on this premise that underlies the concept of the application of telemedicine in CHF. Telemedicine is the monitoring of biological or clinical data in the patient's home with the transfer of information remotely either to a specific structure often managed by nurses or to the GP or cardiologist.

In most studies of telemedicine, effectiveness of the concept is based on the notion of monitoring of some markers with low sensitivity or specificity. This monitoring generates a lot of information which, because of the better education of the patient and from its systematic examination or through technology (internet, phone, SMS) or through remote monitoring of the nurse often leads to detection of sources of unnecessary hospitalization and offset the advantage gained in the early detection of decompensation. In addition, the low sensitivity and specificity of clinical signs generate many warnings that cause difficult remote management by the patient and the doctor. BNP is a blood biomarker recognized as having a high negative predictive value for the diagnosis of CHF and the rate change was correlated with a change in the prognosis. Its dosage is conventionally performed in peripheral blood using POCT devices or not. More recently, it is possible to perform the dosage by the patient itself at home, including a satisfactory feasibility.

This is why, in the HELP study , Investigators wanted to study the impact of the addition of BNP measurement at patient's home to a innovative device for telemedicine monitoring combining patient perception of clinical signs of HF decompensation, daily weight monitoring and strengthening patient education but also specific training of doctors by E learning in order to promote implementation of the ESC recommendations.

Study hypotheses

The primary objective of the HELP study is to determine the impact of a tele monitoring strategy based on either a telemonitoring of the weight associated with an educational reinforcement (clinical monitoring arm) or on the same track associated with a BNP assay at home performed by the patient every week and in case of symptoms suggestive of decompensation (bioclinical monitoring arm) on a primary endpoint including death from all causes, unscheduled re-hospitalization or CHF admission to the emergency department compared to a control group (usual monitoring arm).