Luxembourg Heart Failure Project : Home-Monitoring of Patients with Severe Heart Failure

Coordinating Institution: CRP Sante
Contracting Partner(s): Centre Hospitalier de Luxembourg , CRP Henri Tudor
From: 01/01/2002
To: 31/01/2008
Budget: 462,808.00€
Contact(s): Rösch Norbert , Wagner Daniel R.

Summary

Patients with heart failure (HF) are at increased risk of recurrent hospitalizations and death. Several studies have shown that intensive monitoring of patients with HF can be beneficial. However, the benefit of telemedicine has been modest, perhaps because it has been limited to surveillance of weight, blood pressure and heart rate. We hypothesized that telemonitoring of HF patients can be improved and developed a platform of intensive telemonitoring (MONICARD) including oxygen saturation and pulse transit time (PTT). PTT reflects peripheral vascular tone which is a marker of severity of HF. MONICARD is designed to be used at home by elderly patients and data transmission is secure. MONICARD was first tested in healthy volunteers. Both variability and reproducibility were excellent. In a 1st study in 40 patients with HF class NYHA II-III, we observed a significant correlation between PTT and brain natriuretic peptide and peak VO2, two reference parameters in HF. In a 2nd study in 40 patients with decompensated HF (class NYHA IV), we observed a significant correlation between PTT and peripheral perfusion measured with Laser Doppler. Results from a 3rd study in outpatients from the HF clinic indicate that PTT may be useful to recognize sub-clinical deterioration.

Over the last 12 months, we performed a study (Not alone at home I) evaluating MONICARD in a very sick population of HF patients (hospitalized > 1 week). Of over 20 patients screened, only two patients were enrolled and followed at home with MONICARD. There were no significant technical problems. The reason for low enrolment into this study was patient age, co-morbidities (dementia) and the fact that currently, a prolonged hospitalization is often associated with terminal illness. This was not the case when the study was planned, before implementation of a successful HF clinic.

Routine telemonitoring of in HF patients is now recommended by the European Society of Cardiology (2008 guidelines). Therefore, we propose to evaluate MONICARD in ambulatory patients from the HF clinic. Monitoring with MONICARD will be compared with best usual care, telemonitoring of blood pressure, heart rate and weight. The study (Not alone at home II) will include 48 patients. Another clinical study is currently underway at the Heart Center Bad Oeynhausen, where 80 patients are monitored with MONICARD before and after heart transplantation. The MONICARD system and method have been protected by a patent and commercial use is possible if clinical studies are positive.

Figure 1 : Presentation of the project to Mr. Mars Di Bartolomeo, Minister of Health