European Journal of Heart Failure (2009) 11, 312–318

doi:10.1093/eurjhf/hfp022

Home telemonitoring in heart failure

patients: the HHH study (Home or Hospital
in Heart Failure)
Andrea Mortara1*, Gian Domenico Pinna 2, Paul Johnson 3, Roberto Maestri 2,
Soccorso Capomolla 2†, Maria Teresa La Rovere 2, Piotr Ponikowski 4, Luigi Tavazzi 5,
and Peter Sleight 3 on behalf of the HHH Investigators
1
Department of Cardiology and Heart Failure Unit, Policlinic of Monza, Via Amati 111, 20052 Monza (MI), Italy; 2Department of Biomedical Engineering and Cardiology, S
Foundation-IRCCS, Scientific Institute of Montescano, Montescano (PV), Italy; 3Department of Cardiovascular Medicine and Telemonitoring Research Centre, Nuffield Department
of Obstetrics, John Radcliffe Hospital, University of Oxford, Oxford, UK; 4Department of Cardiology, Clinical Military Hospital, Wroclaw, Poland; and 5Divisione di Cardiologia,
Fondazione Policlinico S. Matteo, IRCCS, Pavia, Italy

Received 22 October 2008; revised 22 December 2008; accepted 2 January 2009

See page 227 for the editorial comment on this article (doi:10.1093/eurjhf/hfp027)

Aims The Home or Hospital in Heart failure (HHH) study was a European Community-funded, multinational, randomized
controlled clinical trial, conducted in the UK, Poland, and Italy, to assess the feasibility of a new system of home tele-
monitoring (HT). The HT system was used to monitor clinical and physiological parameters, and its effectiveness
(compared with usual care) in reducing cardiac events in heart failure (HF) patients was evaluated. Measurements
were patient-managed.
.....................................................................................................................................................................................
Methods From 2002 to 2004, 461 HF patients (age 60 + 11 years, New York Heart Association class 2.4 + 0.6, left ventricular
and results ejection fraction 29 + 7%) were enrolled at 11 centres and randomized (1:2) to either usual outpatient care or HT
administered as three randomized strategies: (i) monthly telephone contact; (ii) strategy 1 plus weekly transmission of
vital signs; and (iii) strategy 2 plus monthly 24 h recording of cardiorespiratory activity. Patients completed 81% of
vital signs transmissions, as well as 92% of cardiorespiratory recordings. Over a 12-month follow-up, there was no
significant effect of HT in reducing bed-days occupancy for HF or cardiac death plus HF hospitalization. Post hoc analy-
sis revealed a heterogeneous effect of HT in the three countries with a trend towards a reduction of events in Italy.
.....................................................................................................................................................................................
Conclusion Home or Hospital in Heart failure indicates that self-managed HT of clinical and physiological parameters is feasible in
HF patients, with surprisingly high compliance. Whether HT contributes to a reduction of cardiac events requires
further investigation.
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Keywords Home telemonitoring † Chronic heart failure † Prognosis † Sleep apnoea † Holter recording

costs and the possible difficulties with patient acceptance of

Introduction
In western countries, ageing populations and escalation in health-
care costs for heart failure (HF) patients have increased the
need for improved home care in place of expensive hospital admis-
sions. Relatively simple solutions have proved to be effective.1 – 5
Recent improvements in technology, including the use of tele-
phone support, now also allow more sophisticated continuous
monitoring in the patient’s home;6 – 8 however, the increased
these novel approaches dictate that they should be rigorously
evaluated.
At present, out of hospital monitoring in chronic HF patients—
measuring vital signs such as heart rate, blood pressure, and
symptoms—is usually performed by the primary care nurse or by a
general practitioner. New telehealth technologies can provide long
distance monitoring of clinical status, improving delivery of care, and
quality of life in chronic HF patients.7,8 New physiological measures

* Corresponding author. Tel: þ39 039 2810563, Fax: þ39 039 2810386, Email: andreamortara@libero.it
†
Present address. Polo Specialistico Riabilitativo, S. Angelo dei Lombardi (AV), Fondazione Don Carlo Gnocchi.
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org.

HT in HF patients
derived from heart rate and respiratory rhythms are now recognized
as predictive factors in HF.9 – 11 Although specific interventions to
target this problem are still under evaluation, home monitoring
might prove cost-effective for HF management.
The multicentre randomized Home or Hospital in Heart Failure
(HHH) study was designed to develop and evaluate a home tele-
monitoring (HT) system to supervise HF patients outside the hos-
pital setting. Besides monitoring vital signs, the HHH study
evaluated a new domiciliary system for long-term non-invasive car-
diorespiratory and activity monitoring, in terms of clinical out-
comes and patient acceptability. This system was designed for
self-management, with the transmission of the acquired data
through standard telephone lines to healthcare providers.
The HHH study was therefore structured as a multinational,
multicentre telemonitoring network, combined with a randomized
open controlled trial, involving 11 centres in three European
countries (UK, Italy, and Poland).
The objectives were as follows: (i) to evaluate the feasibility of
this system in patients with HF; (ii) to compare the efficacy of
HT vs. usual care to reduce the cardiac events in HF patients at
high risk of re-admission; (iii) to define the prevalence and the clini-
cal relevance of home breathing disorders and abnormalities of
heart rate variability. We focused on feasibility data and the clinical
results of the trial.
Methods
Protocol
Eligible patients were first randomized to either usual outpatient care
(control) or HT using a 1:2 allocation. Patients allocated to HT were
then further randomized into following three groups of increasing
complexity (Figure 1). The first group (strategy 1) received monthly
supportive telephone contacts from a study nurse to check on their
clinical status. The second group (strategy 2) received the same
Figure 1 Flow diagram of the Home or Hospital in Heart failure (HHH) study. NICRAM, non-invasive cardiorespiratory and activity
monitoring.
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313
telephone support, but also transmitted their vital signs and other
data (discussed subsequently), including details of changes in weight,
blood pressure, and symptoms, weekly by telephone. Patients assigned
to strategy 2 also performed monthly cardiorespiratory recordings;
however, these data were transmitted for research purposes only
and were not made available to the clinical team. The third group
(strategy 3) carried out the same measurements as patients in strategy
2, but the monthly 24 h cardiorespiratory recordings were made avail-
able for clinical management (if required).
Inclusion and exclusion criteria
Inclusion criteria were (i) age .18 and ,85 years; (ii) New York
Heart Association (NYHA) classes II – IV; (iii) aetiology: ischaemic, idio-
pathic, hypertensive, or valvular; (iv) left ventricular ejection fraction
40%; (v) abnormal diastolic echocardiographic pattern (from
E/A,1 to a more severe pattern); (vi) hospital admission for HF or
decompensation in the previous 12 months; and (vii) optimized
medical therapy.
Exclusion criteria were (i) myocardial infarction, revascularization or
ICD implantation in the previous 6 months; (ii) angina or objective myo-
cardial ischaemia requiring future revascularization; (iii) implanted ventri-
cular or atrial pacemaker (except DDD pacemakers with good sinus
activity); (iv) insulin-dependent diabetes or severe disease-limiting survi-
val; (v) poor compliance with HT system; (vi) inclusion in another trial.
Randomization
The randomization list was generated by the coordinating centre in
Montescano, Italy, with separate blocks held in each country. The indi-
vidual patient allocation was to be revealed only after the patient iden-
tifiers (name, surname, and the date of birth) had been received at
each national randomization centre.
Study outcomes
Primary endpoints were as follows: bed-days occupancy for HF in
acute medical/surgical beds and composite endpoint of cardiac
death and hospitalization due to HF. Secondary endpoints were:
(i) bed-days occupancy for all cardiovascular reasons; (b) all-cause

314
mortality; and (c) all-cause hospitalizations. All endpoints were adjudi-
cated by an independent, blinded, Endpoint Committee.
Sample size calculation
We assumed that patients in the control arm would show a median
bed-days occupancy of 20 bed-days/year (95% confidence interval:
11–73 bed-days/year) based on two admissions of 10 days each and
that this would be reduced by 25% by HT. To detect this change with
a two-sided type I error of 0.05 and a power of 85%, a sample size of
at least 450 subjects, with subjects allocated in a ratio of 1:2 between
usual clinical care and HT, respectively, was necessary. The calculations
p
were performed after an arcsin( fPg) normalizing transformation, where
P is the proportion of bed-days in a year. The sample size was also
adequate for testing the second primary endpoint of the study.
Study organization
The enrolment period was followed by a 12-month observation
period. A clinical assessment, ECG, blood test, and echocardiogram
were performed at baseline (þ24 h cardiorespiratory recording) and
at 12-months of follow-up.
Patients randomized to the control arm were informed about the
study, but were not given all of the details of the HT system. After ran-
domization, those patients allocated to the control arm were dis-
charged as normal from the hospital. Patients enrolled in the HT
arms were given educational support about how to use the HT
devices, including the cardiorespiratory recorder and the modem,
the digital blood pressure monitor (UA-767, A&D Company, Tokyo,
Japan), and the electronic weighing scale. A detailed user manual, a
diary, and study forms for measuring and transmitting vital signs
were given to each patient. For patients enrolled in the outpatient
clinic, the same procedures were followed.
Monitoring at home
The design of the telemonitoring system has been presented pre-
viously.12 The patients enrolled in HT strategies 2 and 3 transmitted
weekly records of the following data to the coordinating centre via
an automated interactive voice response (IVR) system: (i) weight;
(ii) heart rate; (iii) systolic arterial pressure; (iv) dyspnoea score
(1 – 10); (v) asthenia score (1 – 10); (vi) oedema score (1, feet swell
in the morning; 2, in the evening; 3, always swollen); (vii) changes in
therapy; and (viii) blood results.
Patients in HT strategies 2 and 3 were also given a portable device
(a solid-state lightweight Holter-style recorder with built-in signal
pre-processing, FM, Monza, Italy), which continuously recorded ECG,
respiration, and physical activity over 24 h at home. The recorders
(managed by the patients) automatically transmitted data by a tele-
phone, through a dedicated modem (Appel Electronica srl, Torino,
Italy), for analysis by the coordinating centre.
A 24 h answering machine allowed each patient to contact his/her
reference hospital at any time and leave a message requesting help
or advice (all HT groups).
As tested in a previous pilot study,13 each transmitted vital sign par-
ameter was subjected to an automatic range check and to a stability
check, based on the rate of change of each parameter over time.
Any suspect data elicited a request for checking by the monitoring
nurse or attending physician. No specific rules were given in the pro-
tocol for medical interventions when one of the specific parameters
exceeded the pre-specified personalized normal range and the range
of variation. Investigators (nurses or physicians) could choose the
best action to re-establish the haemodynamic balance following
modern guidelines.14
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A. Mortara et al.
Education and technical support
Care and practice sessions were devoted to educating the patients in
the use of the HT devices: the cardiorespiratory recorder and the
modem, the digital blood pressure monitor (UA-767, A&D
Company), and the electronic weighing scale. A detailed user
manual, a diary, and study forms for measuring and transmitting vital
signs were given to the patients.
Technical support for the enrolling centres and the national coordi-
nating centres was provided by the coordinating centre (Montescano,
Italy), using remote assistance with occasional onsite support. In
Poland and the UK, first-level technical support was provided by the
central signal analyst. Support for the IVR system was provided by
the manufacturer (Appel Elettronica).
Statistical analysis
Comparisons of baseline clinical characteristics between different
groups were carried out by one-way analysis of variance (continuous
variables, normal distribution), Kruskal– Wallis test (continuous vari-
ables, non-normal distribution), or x2 test (categorical variables).
Bed-days occupancy was computed as the proportion of hospitaliz-
ation days during each patient’s follow-up, multiplied by 365, and
expressed as bed-days/year. The normalization allowed us to take
into account possible differences in mortality, heart transplantation,
and withdrawals from the study, between groups. Since a limited
number of patients experienced an HF hospitalization during the
follow-up, ordinary descriptive statistics (e.g. median and interquartile
range) and related statistical tests were inadequate to summarize and
compare bed-day occupancy among the different groups. Therefore,
bed-days occupancy was categorized into three levels: 0 bed-days/
year, below the median value, and equal or above the median value
bed-days/year. The association between this variable and telemonitor-
ing was assessed by logistic regression analysis (generalized logit).
We also analysed the number of hospitalizations in each patient, as
this variable takes into account the whole burden—for the patient and
for the healthcare system—of repeated hospitalizations. Also, this vari-
able was categorized into three levels: zero, one, and two or more
hospitalizations; its association with telemonitoring was assessed by
logistic regression analysis.
Event-free survival curves were estimated by the Kaplan– Meier
method and compared by the log-rank test. For the composite end-
point of cardiac death plus HF hospitalization, the time-to-event was
set at the occurrence of death or at the first hospital admission (if
any). The association between this endpoint and telemonitoring was
assessed by logistic regression analysis.
A P-value less than 0.05 was considered statistically significant, and
all tests were two-sided. Since two co-primary endpoints were ana-
lysed in the study, a correction for multiplicity was required. There-
fore, we conservatively used a 0.025 significance level for each of
them. All statistical analyses were carried out using the SAS/STAT stat-
istical package, release 9.1.3 (SAS Institute Inc., Cary, NC, USA).
Results
Patients were recruited between July 2002 and July 2004. Recruit-
ment was particularly difficult in the UK centres, as care strategies
there aim to avoid hospital admission (a required study entry cri-
terion). In the UK, care was largely based on the community
with the general practitioner, with occasional follow-up visits to
a hospital clinic where necessary. Overall, 617 eligible patients
were identified; of these, 103 declined to participate and 50
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HT in HF patients 315

Table 1 Baseline clinical characteristics

Controls (n 5 160) HT (n 5 301) HT strategy 1 (n 5 104) HT strategy 2 (n 5 96) HT strategy 3 (n 5 101)

...............................................................................................................................................................................
Age (years) 60 + 12 60 + 12 60 + 12 60 + 12 59 + 11
Age .65 years (%) 39 32 34 35 28
Female (%) 17 14 14 11 16
Ischaemic aetiology (%) 59 54 58 55 50
NYHA class 2.3 + 0.6 2.4 + 0.6 2.4 + 0.6 2.3 + 0.5 2.5 + 0.6
NYHA 3 (%) 34 43 43 36 49
LVEF (%) 30 + 7 28 + 7 29 + 8 29 + 7 28 + 8
LVEDD (mm) 66 + 9 67 + 9 66 + 8 67 + 9 67 + 9
Baseline HR (b.p.m.) 73 + 14 75 + 14 74 + 15 74 + 15 76 + 14
Baseline SAP (mmHg) 117 + 17 117 + 18 117 + 16 119 + 20 115 + 17
Baseline DAP (mmHg) 74 + 12 73 + 10 73 + 11 74 + 11 73 + 10
BUN (mg/dL) 49 + 23 48 + 23 52 + 25 48 + 25 44 + 17
Sodium level (mEq/L) 140 + 4 140 + 4 140 + 4 140 + 3 140 + 4
Creatinine (mg/dL) 1.20 + 0.33 1.22 + 0.34 1.24 + 0.34 1.24 + 0.35 1.18 + 0.33
Potassium (mEq/L) 4.4 + 0.5 4.4 + 0.5 4.5 + 0.4 4.4 + 0.5 4.4 + 0.4
Bilirubin (mg/dL) 0.83 + 0.45 0.90 + 0.58 0.89 + 0.63 0.93 + 0.57 0.89 + 0.56
ACE-inhibitors (%) 87 87 89 82 90
Beta-blockers (%) 87 84 84 84 83
Diuretics (%) 87 87 84 88 88

HT, home telemonitoring.

were excluded for logistical reasons. Therefore, the final enrolment
included 464 patients. Due to technical problems in the activation of
telemonitoring devices at home, three enrolled patients could not
participate in the study, leaving a final sample of 461 subjects: 215
from Italy, 187 from Poland, and 59 from the UK (Figure 1). Baseline
clinical characteristics of the control patients and of those random-
ized to HT are reported in Table 1. Patients were predominantly
men, with a mean age of around 60 years (older in the UK), with
about one-third aged above 65. Treatment with angiotensin-
converting enzyme-inhibitors, beta-blockers, and diuretics was
given in 82–90% of the patients, indicating good medical therapy.
The baseline characteristics (Table 2) of the treatment groups
were well balanced in both Italy and the UK. However, in
Poland, the telemonitored arm had significantly higher NYHA
class, lower ejection fraction, higher left ventricular enddiastolic
diameter, and worse dyspnoea score, compared with the usual
care (control) patients.
Feasibility of the telemonitoring system
Patients completed 81% (75% in Poland, 82% in Italy, and 93% in
the UK) of all practicable vital signs transmissions from home.
Compliance was unrelated to NYHA class (P ¼ 0.1) or older age
(P ¼ 0.25). A total of 439 voice messages were left on the 24 h
answering machine—mainly for advice, but also for transmission
of results or technical difficulties.
A baseline cardiorespiratory recording was performed in 443
patients (96%); 1630/2078 anticipated home cardiorespiratory
recordings for strategies 2 and 3 and were actually practicable
(technical problems, holidays, or other absences were the com-
monest cause for non-practicability). Overall, 92% of practicable
recordings were carried by the patients (85% in Poland, 82% in
Italy, and 99% in the UK), confirming high feasibility of a self-
administered cardiorespiratory recording at home.
Telemonitoring and outcome
During a mean follow-up of 11.6 + 2.7 months (the planned
observational period was 12 months), 18 patients dropped out
of the study and 33 died (30 from cardiac causes). During the
follow-up period, 124 episodes of hospitalization for HF occurred
in 81 patients—a single admission in 52 and two or more in 29. A
further 34 hospitalizations were cardiac but not due to HF; 110
admissions were non-cardiac.
There was no significant effect of HT in reducing bed-days occu-
pancy for HF, cardiac death plus HF hospitalization, or the number of
re-hospitalizations (Table 3). None of the HT strategies was superior
to the others in identifying patients at higher risk of events.
A post hoc analysis revealed a highly significant interaction
between HT and country in the association with the number of
HF hospitalizations (P ¼ 0.041) and cardiac deathþHF hospitaliz-
ation (P ¼ 0.004), indicating a heterogeneous effect of HT in the
three countries. In Italy, when compared with Poland and the
UK, a reduction in the number of multiple (two or more) HF hos-
pitalizations was observed in the HT group (3 vs. 11%, P ¼ 0.02).
Moreover, the composite endpoint of cardiac death and HF hospi-
talization was more likely for usual-care patients (25%) than tele-
monitored patients (12%, P ¼ 0.016) (Figure 2). In contrast, in
Poland, we observed an opposite trend: both the number of mul-
tiple HF hospitalizations and the composite endpoint of cardiac
deathþHF hospitalization were increased in the HT group [9 vs.
3% (P ¼ 0.13), and 35 vs. 24% (P ¼ 0.12)].
 18790844, 2009, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1093/eurjhf/hfp022 by Nat Prov Indonesia, Wiley Online Library on [01/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
316
Table 2 Baseline clinical characteristics according to country

Italy Poland UK
....................................................... ....................................................... ......................................................
Controls (n 5 72) HT (n 5 143) Controls (n 5 67) HT (n 5 120) Controls (n 5 21) HT (n 5 38)
.............................................................................................................................................................................................................................................
Age (years) 59 + 12 57 + 11 59 + 10 59 + 10 68 + 11 71 + 9
Age .65 years (%) 33 24 34 27 71 79
Female (%) 17 11 12 17 33 13
Ischaemic aetiology (%) 44 47 72 59 71 66
NYHA (class) 2.4 + 0.6 2.4 + 0.6 2.3 + 0.5 2.5 + 0.5 2.2 + 0.7 2.3 + 0.4
NYHA .3 (%) 39 41 32 51* 25 26
LVEF (%) 28 + 6 29 + 7 32 + 7 29 + 7* 26 + 8 26 + 8
LVEDD (mm) 68 + 11 67 + 9 65 + 8 68 + 8* 60 + 7 63 + 7
Dyspnoea score 2.1 + 1.9 2.2 + 1.5 3.2 + 2.3 4.0 + 2.5* 4.3 + 2.4 4.4 + 2.2
Baseline HR (b.p.m.) 70 + 11 71 + 12 77 + 14 80 + 15 68 + 16 73 + 16
Baseline SAP (mmHg) 115 + 17 114 + 16 122 + 16 120 + 19 111 + 18 121 + 20
Baseline DAP (mmHg) 72 + 9 73 + 9 78 + 14 75 + 12 65 + 11 69 + 9
BUN (mg/dL) 59 + 27 53 + 22 44 + 15 48 + 23 34 + 18 31 + 15
Sodium level (mEq/L) 140 + 4 140 + 3 141 + 5 139 + 5* 138 + 4 139 + 4
Creatinine (mg/dL) 1.19 + 0.35 1.19 + 0.32 1.11 + 0.23 1.17 + 0.28 1.50 + 0.38 1.52 + 0.41
Potassium (mEq/L) 4.3 + 0.4 4.3 + 0.4 4.6 + 0.5 4.6 + 0.5 4.6 + 0.5 4.4 + 0.5
Bilirubin (mg/dL) 0.79 + 0.42 0.85 + 0.47 0.91 + 0.49 0.98 + 0.66 0.70 + 0.28 0.81 + 0.67
ACE-inhibitors (%) 85 83 90 91 86 92
Beta-blockers (%) 82 84 93 90 86 63
Diuretics (%) 90 81 85 91 86 95

*P , 0.05 vs. controls.

HT, home telemonitoring.

A. Mortara et al.
 18790844, 2009, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1093/eurjhf/hfp022 by Nat Prov Indonesia, Wiley Online Library on [01/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
HT in HF patients 317

Table 3 Outcome measures

Controls HT HT strategy 1 HT strategy 2 HT strategy 3

(n 5 160) (n 5 301) (n 5 106) (n 5 94) (n 5 101)
...............................................................................................................................................................................
Total potential days 59 016 103 646 38 216 31 726 33 704
Patients hospitalized for all causes 48 (30%) 106 (35%) 37 (35%) 34 (36%) 35 (35%)
Number of hospitalizations for all causes 98 170 59 62 49
Total days in hospital for all causes* 975 (1.7%) 2021 (1.9%) 784 (2.1%) 693 (2.2%) 544 (1.6%)
Patients hospitalized for HF 28 (18%) 53 (18%) 18 (17%) 17 (18%) 18 (18%)
Number of hospitalizations for HF 44 80 29 27 24
Total days in hospital for HF* 584 (1.0%) 1175 (1.1%) 477 (1.2%) 374 (1.2%) 324 (1.0%)
Bed-days occupancy for HF
0 bed-days/year 132 (83%) 248 (82%) 88 (83%) 77 (82%) 83 (82%)
.0 and ,14 bed-days/year 15 (9%) 25 (8%) 8 (8%) 7 (7%) 10 (10%)
14 bed-days/year** 13 (8%) 28 (9%) 10 (9%) 10 (11%) 8 (8%)
Patients with one HF hospitalization 18 (11%) 34 (11%) 10 (9%) 9 (10%) 15 (15%)
Patients with two or more HF 10 (6%) 19 (6%)* 8 (8%) 8 (9%) 3 (3%)
hospitalizations

HT, home telemonitoring.

*Total counts (percentage of potential days).
**14 bed-days/year is the median value in the overall population.

Figure 2 Kaplan– Meier cumulative event-free rate, for the
composite endpoint of cardiac death and heart failure hospitaliz-
ation, in the whole population and in the Italian group.
Discussion
The HHH study has demonstrated that HT of vital signs and
cardiorespiratory signals is feasible, with surprisingly high patient
compliance, which was similar in the three countries with different
healthcare systems. The technology was easy to use and was man-
ageable by elderly patients without family support, whatever age or
HF severity.
Disappointingly, in the overall HHH population, HT did not
allow an early identification of clinical deterioration,or reduce hos-
pitalization and mortality.
There are several possibilities for this unexpected result. First, the
unexplained imbalance in baseline characteristics in the large Polish
cohort was likely the cause for the unanticipated trend towards a
better outcome in usual care patients observed in this country.
Secondly, since the computation of the sample size was based on his-
torical data, the study was underpowered in relation to the actual
rates of events observed in the cohort of patients included in the
study. As shown in Table 2, HHH patients were optimally treated
according to current guidelines, which was not likely the case in
the historical data used for sample size computation. Thirdly, the
study centres were all highly experienced in HF management; there-
fore, the ‘usual care’ was possibly better than ‘usual’. Fourth, we used
only intermittent monitoring of vital signs, as opposed to daily moni-
toring, as was used, for instance, in the TEN-HMS study.15 However,
even this study failed to show a reduction in HF hospitalization,
which suggests that weekly monitoring in HHH did not likely play
a major role in the study results. Finally, we cannot exclude that
actions taken by the different medical-nursing staff in response to
HT alerts were in some instances not well-timed or effective. As
already pointed out earlier, however, all enrolling centres were
highly experienced in the management of HF, and practice was
according to current guidelines.
When analysis was restricted to Italy (which had the largest
enrolment and no imbalance in baseline characteristics between
the treatment groups), HT showed a clear trend towards reducing
the occurrence of multiple HF hospitalizations and the cumulative
endpoint of cardiac death and HF hospitalization. The analysis per
country, however, was not pre-specified at the beginning of the
study and should be considered with caution as a post hoc analysis.
The observed heterogeneous results in the different countries
support the relevance of exploring the effects of HT in specific
settings—as the clinical use of such techniques is potentially sensi-
tive to local attitudes and patients’ and physicians’ behaviour—and
also the need for larger sample sizes to avoid baseline imbalances
such as those occurred in the Polish cohort of this study.
Recent meta-analyses of multidisciplinary strategies for the
management of HF patients have shown that HT contributes to

318
a better clinical outcome for cardiac death and hospitalizations.6,7
Most of these were single-centre studies, with different monitoring.
Clark et al.7 in a new meta-analysis divided studies into those with
only telephone support and those with monitoring of clinical par-
ameters. Remote monitoring was more effective in reducing
cardiac mortality than simple telephone contact (relative risk
0.62 vs. 0.85). In contrast, ‘HF hospitalization’ was significantly
affected by structured telephone contact, particularly when inte-
grated with effective multidisciplinary care. In the only multicentre
study that tested remote monitoring of clinical parameters, death
(but not hospitalization for HF) was significantly reduced.15
Conclusions
The HHH study has shown, in three different European countries,
that long-term self-managed monitoring of clinical status and cardi-
orespiratory activity is surprisingly feasible at home, even in the
elderly, using simple measurement devices, an automated IVR
system, and data transmission via a standard telephone line. In
addition to capturing unique clinical data, these new technologies
may increase the patient’s awareness of the disease and facilitate
home care and management of chronic disease, and potentially, as
observed in the Italian setting, reduce phases of clinical instability.
Acknowledgements
We are grateful to all investigators (physicians, nurses, and tech-
nicians) who have enthusiastically worked in the HHH study. We
also thank M. Sanarico for his support in the statistical analyses.
Conflict of interest: none declared.
Funding
HHH was supported by E.C. grant (Action line 10.1 ‘Public Health,
contract no. QLGA-CT-2001-02424).
Appendix
Steering Committee: P.S. (Chairman), A.M., G.D.P., P.J., M.T.L.R., P.P.,
L.T.; Scientific Board: P.S., L.T., H. Dargie; Medical Committee: A.M.
(Chairman), S.C., J. Dwight, M. Emdin, A. Di Lenarda,
C. Campana, P.P., R. Gill, R. Szelemej, M. Barlow; Technical Commit-
tee: G.D.P. (Chairman), R.M., D. Andrews, T. Witowski; Writing
Committee: P.S., G.D.P., A.M., P.P., P.J.; Event Committee:
C. Opasich (Chairman), G. Specchia, G. Rackzak; Enrolling
Centres: University of Oxford, TMR and Department of Cardiovas-
cular Medicine, John Radcliffe Hospital Oxford, UK (P.S., P.J.,
D. Andrews, J. Dwight); Fondazione S Maugeri Clinica del Lavoro
e della Riabilitazione, Montescano, Italy (G.D.P., S.C., M.T.L.R.,
R.M.); Istituto di Fisiologia Clinica, CNR, Pisa, Italy (M. Emdin,
C. Passino); Policlinico di Monza, Monza, Italy (A.M., C. Bersano);
Azienda ‘Ospedialiera Riuniti’, Trieste, Italy (A. Di Lenarda,
18790844, 2009, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1093/eurjhf/hfp022 by Nat Prov Indonesia, Wiley Online Library on [01/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
A. Mortara et al.
L. Vitali Serdoz); IRCCS Policlinico San Matteo, Pavia, Italy (L.T.,
C. Campana); Clinical Military Hospital, Wroclaw, Poland (P.P.,
K. Nowak, T. Witowski); Central Hospital of Ministry Affairs and
Administration, Warsaw, Poland (R. Gill, A. Pawlak); Dr
A. Sokolowski Hospital. Walbryzch, Poland (R. Szelemej,
A. Jurczyk); University of Glasgow, Glasgow, UK (H. Dargie, M.
Barlow); Romford Cardiovascular Research, Romford, UK.
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