Influence of Home Monitoring on the clinical status of heart failure patients: Design and rationale of the IN-TIME study

BACKGROUND: Despite optimal drug and device therapy, frequent hospitalisations due to decompensated heart failure remain an issue. Early detection of decompensation could prevent hospitalisation in patients with congestive heart failure. The recently introduced Home Monitoring functionality of implanted devices is a promising new telecardiology technique which provides information on the status of heart failure. Home Monitoring observation of heart failure patients could lead to early detection of preclinical decompensation, enable early intervention before clinical decompensation, and thus could prevent hospitalisations. OBJECTIVE: The IN-TIME study is designed to assess the impact of Home Monitoring on the early detection of worsening congestive heart failure and the clinical status of heart failure patients. STUDY DESIGN: Approximately 620 patients will be prospectively randomised to patient management guided by Home Monitoring analysis or standard care and followed for 12 months. The endpoints committee will adjudicate events in a blinded fashion. The primary endpoint is a composite of all-cause mortality, unplanned hospitalisation due to worsening heart failure, NYHA class and patient global self assessment (Packer score). The study should complete recruitment during 2009 and report in late 2010.