A multi-country randomised trial of the role of a new telemonitoring system in CHF: the HHH study (home or hospital in heart failure). Rational, study design and protocol

Journal article

The HHH study will be a full scale randomized controlled trial in Italy, Poland and UK enrolling 450 CHF patients (LVEF <40%, NYHA cl. II-IV) in 2 arms (usual clinical practice and home-care strategy). Objectives will be: (1) to determine if different strategies of home-care telemonitoring, affect hospital admissions, improve patient sense of well-being, and reduce overall costs of medical care; (2) to define the prevalence and the clinical impact of breathing disorders, arrhythmias and abnormalities of HRV in the occurrence of acute periods of instability and when on optimal therapy; (3) to evaluate in the home setting a new system for continuous monitoring of cardio-respiratory signals plus physical activity with teletransmission of recorded data embedded in an interactive voice response based telehealth system. The 300 'home strategy' patients will be divided into: (1) normal clinical practice supplemented by telephone contacts; (2) as strategy 1 plus periodic telemonitoring of vital signs parameters; (3) as 2deg; strategy plus periodic 24 h ECG, respiration and physical activity (NICRAM) recording. Enrolment will be over 12 months with a further 12 months follow-up. The primary end-point will be total bed-days occupancy for heart failure in acute medical/surgical beds. The first patient was enrolled in September 2002. The trial is expected to be completed at the middle of 2005. © 2004 The European Society of Cardiology. Published by Elsevier Ltd. All rights reserved.

Authors: Mortara, A; Pinna, G; Johnson, P; Dargie, H; La Rovere, M

• Publication status: Published
• Journal: EUROPEAN HEART JOURNAL SUPPLEMENTS
• Volume: 6
• Issue: F
• Pages: F99-F102
• Publication date: 2004-11-01
• DOI: 10.1016/j.ehjsup.2004.09.003
• ISSN: 1520-765X
• Language: English
• Keywords: tetemonitoring; chronic heart failure; steep apnoea; long-term recording