The European Society of Cardiology
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
a Divisione di Cardiologia e Unita' Scompenso Cardiaco, Policlinico di Monza, Via Amati 101, 20054 Monza MI, Italy
b Divisioni di Bioingegneria e di Cardiologia, Fondazione "S. Maugeri", IRCCS, Istituto Scientifico di Montescano (Pv), Italy
c University of Oxford, Departments of Cardiovascular Medicine and Telemonitoring Research Center, Nuffield Department of Obstetrics, John Radcliffe Hospital, Oxford, UK
d Cardiac Research Department, University of Glasgow, Western Infirmary, Glasgow, UK
e Department of Cardiology, Clinical Military Hospital, Wroclaw, Poland
f Divisione di Cardiologia, Policlinico S. Matteo, IRCCS, Pavia, Italy
* Correspondence: Tel.: +39 039 2810563; fax: +39 039 2810386 (E-mail: andreamortara{at}libero.it).
Abstract
AIMS: 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).
METHODS AND RESULTS: 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 2° 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.
CONCLUSIONS: The first patient was enrolled in September 2002. The trial is expected to be completed at the middle of 2005.
Keywords Telemonitoring; Chronic heart failure; Sleep apnoea; Long-term recording