A combined diagnostic-therapeutic strategy to optimize management of patients with previously unrecognized heart failure in primary care

Heart failure is an emerging epidemic in especially the elderly, with high
mortality rates, substantial loss in quality of life, and high healthcare
costs, mainly due to hospitalizations. The majority of (usually elderly)
patients with heart failure are diagnosed and managed in primary care. However
underdiagnosis and undertreatment of patients with heart failure in primary
care are common. Implementation of a standardized diagnostic protocol together
with educating general practitioners in a pragmatic treatment strategy in which
the focus lays on uptitration of heartfailure medication, would fill the gap of
underdiagnosis and undertreatment that nowadays exists in primary care.

To determine the effect of a structured diagnostic-therapeutic strategy to
detect and treat previously unrecognized or unestablished heart failure in
primary care as compared to care as usual.

Combination of a diagnostic implementation study and cluster randomized trial
in primary care. All participants will undergo a standardized diagnostic
work-up to establish or rule out heart failure. In those participants with an
abnormal ECG and/or elevated natriuretic peptide level additional
echocardiography will be performed at the outpatient clinic of the
Diakonessenhuis in Zeist. The definite diagnosis of heart failure ('systolic'
or 'diastolic') will be established by an expert panel consisting of two
cardiologists and a general practitioner. The panel will apply the criteria of
the updated heart failure guidelines (2008) of the European Society of
Cardiology (ESC). Patients with heart failure will subsequently be treated by
their own general practitioner. The participating general practitioners will be
randomly divided into either care as usual (control group) or special
up-titration (intervention group). Both groups will be using medication as
recommended in the Dutch heart failure standard. However, general practitioners
in the intervention group will be especially trained in the practical appliance
of this guideline: the initiation of diuretics and ACE-inhibitors and
structured up-titration of ACE-inhibitors and beta-blockers. In the training,
practical examples will be used concerning barriers the general practitioners
themselves encountered when using this medication. In the intervention group,
patients with 'systolic' heart failure will receive the recommended maximal
dose or the highest tolerated dose. Patients with 'diastolic' heart failure
will receive optimal blood pressure and heart rate control with the preferred
cardiovascular drugs. At baseline and six months after heart failure is
established or ruled out, all participants fill out quality of life
questionnaires. During those six months, only participants with heart failure
will additionally fill out one of these questionnaires every three weeks.
Participants with heart failure will also be asked to perform the 6 minutes
walking test shortly after the diagnosis was made and again after six months of
follow-up. Also after six months, electronical files of the general
practitioners will be scruntinized to assess the (dosage of) prescribed
medication.

At the start of the study participants will be asked to fill out two
questionnaires about their quality of life (SF-36 and EQ-5D) and to undergo
structured history taking, physical examination, bedside NTproBNP testing (=
venapuction), and ECG in a visit to the researcher. If there is an indication
for heart failure, the participant will undergo additional echocardiography in
Diakonessenhuis Zeist. Participants with heart failure established with
echocardiografy will be asked to perform the six minutes walking test shortly
after diagnosis is made and after 6 months follow-up. All participants will be
asked to fill out the aforementioned questionnaires, together with four
questions about dyspnea and quality of life, again six months after heart
failure is established or ruled out. The ones with a definite diagnosis of
heart failure will also be asked to fill out the 'Minnesota living with heart
failure questionnaire' once, and during the follow-up time of six months the
EQ-5D every three weeks . The first assessment will take one hour, the
echocardiography half an hour. Completion of the questionnaires at baseline and
after six months will take 30-40 minutes, and participants with heart failure
have to invest an additional 40 minutes to fill out the EQ-5D eight times
extra. The six minutes walking test will be performed twice on a location
nearby, which takes a maximum of 30 minutes. All together, the participant will
have to invest approximately 1.5-3.5 hours, depending on whether the diagnosis
heart failure is made. With the exception of possible bruising after
venapunction, no other risks are expected with participation. Beneficial for
the participants is that they will find out if their shortness of breath is
caused by heart failure, and if so, treatment could have a positive effect on
their quality of life and eventually mortality. In a broad sense this strategy
could implicate adequate identification and treatment of patients with
unrecognized heart failure, with improvement of prognosis as a result. Direct
implementation of this strategy in general practices across the Netherlands
seems feasible.