The Chronic Heartfailure Prevention Project

Chronic Heart Failure (CHF) is a chronic heart condition in which the heart
pump is unable to meet the demands for adequate circulation of the blood. CHF
is a common disorder. In The Netherlands 1% of the general population suffers
of CHF which currently refers to 159.000 people. Depending on age, the year
prevalence increases from 3/1000 in people between 15 - 64 years of age to
86/1000 in people over 65 years. In the next three decades, the number of aging
people will dramatically increase: by 2040, 4.6 million people (one third of
the total population) will be over 65. This means that the number of patients
with CHF will also increase (there are estimates that the absolute number of
people with CHF between 2005 and 2025 will increase by 46.9%).

In general, the level of symptoms in CHF are defined by the New-York Heart
Association criteria (NYHA classes I - IV). In class I, there are no signs and
symptoms during normal physical exercise. In class II, there are no signs and
symptoms when resting but normal physical exercise results in symptoms of
fatigue and chest pain. In class III, there are no symptoms at rest, but any
minimal physical exercise provokes serious symptoms. In class IV, there are
signs and symptoms at rest, any (minimal) physical activity results in
increasing symptoms.
CHF is a serious condition. In patients with CHF the mortality rate is 37% < 1
year, 49% < 2 years and 65% < 5 years after diagnosis. Annually, in our
country, approximately 6900 patients die because of CHF, which is 18% of total
deaths because of heart disease. Moreover, another 25.000 patients are
hospitalized which means that about 20% (31.900/159.000) of all patients
suffering from CHF annually passes through a major event because of CHF (death
or hospitalization). In 2005, the direct health costs because of CHF were
estimated on 387.5 million euro, which is 1% of total health costs in the
Netherlands and 7% of total costs because of heart disease in general. Apart
from direct signs and symptoms of CHF, many patients suffer from decreased
quality of life. Because of symptoms at minimal exercise, many patients stay at
home, most of the time seated in a chair, and are unable to have social
contacts. Depression because of loneliness is very common in CHF patients.
Moreover, high levels of anxiety exist because of fear of an exacerbation of
symptoms, often resulting in hospitalization and higher mortality.

In general, two different classes of CHF can be discriminated: systolic and
diastolic CHF. In the first category, decreased contractility of the heart
muscle is the main reason of heart failure most often caused by ischemic heart
disease or cardiomyopathy. In diastolic heart failure, there is a decreased
left ventricular filling most often caused by decreased relaxation of the
ventricular muscle because of hypertrophy or fibrotic processes. The
distinction between the two classes of heart failure is not absolute and often
diastolic HF proceeds systolic HF, like in ischemic disease and hypertension.
Therefore, the recent CBO guidelines report a distinction between HF with
normal ventricular ejection fraction (VEF > 50%) and HF with a decreased VEF (<
50%).

An important cause of CHF is hypertension. Because of chronic increased
tension, there is at first a decreased left ventricular filling hardly
affecting the contractility (diastolic HF). However, after years, this is
followed by a dilatation of the left ventricle with decreased contractility
(systolic HF). As a consequence of increased intravascular volume, the
ventricular muscle produces brain natriuretic peptide (BNP) which tries to
compensate the overfilling by increasing natriurese and vasodilatation.
Increased levels of BNP can be a first manifestation of HF.
Hypertension (HT) is very common in Primary Care (PC). In the general
population, in men between 20 and 60 years of age one out of four has
hypertension (>= 140/90 mmHg), which is one out of five in women of similar age.
In men over 65 years of age, 38% has hypertension compared to 42% of the women.
During the last decade, once the diagnosis of HT has been confirmed and no
secondary causes have been demonstrated, most of the HT patients in PC are
treated by a PC practice nurse. Until now, there are no data on the prevalence
of CHF in **asymptomatic** or **stable** HT patients in Primary Care.

A major public health issue is the underestimation of CHF in the general
population. Many patients with (early stages of) CHF do not visit their GP to
complain about signs and symptoms possible related to CHF but rather consult
for regular check-ups of blood pressure, cholesterol, diabetes parameters e.g.
However, the GP can assess BNP in patients at risk for HF and more recently has
access to echocardiogram*s (EC). EC is a non-invasive patient friendly method
to detect early signs of abnormal structural and / or functional heart activity
at rest that are prognostic factors for developing HF.
The consequences of inappropriate diagnosis and treatment of CHF are
substantial. Once a patient is in class III and class IV, apart from death,
many patients need frequent hospitalizations and a substantial part of them are
referred to nursing homes. Until now, the reliability (sensitivity,
specificity, positive predictive value) of BNP and EC assessments in
**asymptomatic** HT patients in PC to predict the development of future HF is
not known. Therefore, the main topic of CHEAP is to evaluate whether there are
adequate tools for the GP to detect patients at risk for developing future
HF.

The mission of CHEAP is to evaluate whether a protocol can be developed that
enables the GP to detect patients with primary hypertension who are at risk for
developing future heart failure.
The European Society of Cardiology has recently (2008) defined three different
categories of HF.
(1) Newly developed HF: first manifestation of acute HF
(2) Temporary HF: HF that disappears over time such as in myocarditis
(3) Chronic HF: irreversible HF that can be stable, progressive or an
exacerbation.
Within CHEAP, determinants of category I and III in a population at risk to
develop HF will be investigated.

Primary outcome of CHEAP is:
At a cross-sectional level
1. Is it possible to define a profile of HT patients in Primary Care who are at
risk of developing HF, with regard to:
Signs and symptoms
Assessment of BNP
Assessment of ECG
Assessment of EC
2. What is the outcome of screening of Primary Care HT patients with assessment
of signs and symptoms, BNP, ECG and EC with regard to:
Diagnosis of chronic heart failure
Medication
Referral to secondary care
Follow-up
At a prospective level:
3. Does intervention in Primary Care HT patients at risk to develop future HF
benefit in term of risk reduction?

Secondary outcome of CHEAP is:
At cross-sectional level
1. Do Primary Care HT patients with a high risk profile of HF differ from those
with low profile in terms of quality of life?
2. Is there a difference in depression and anxiety levels between Primary Care
HT patients with and without a high risk profile of HF?
At a prospective level
1. Does intervention in patients with a high risk profile of HF contribute to
better quality of life?
2. Does intervention in patients with a high risk profile of HF interfere with
levels of depression and anxiety?

HT Patients between 60-85 years who meet the inclusion criteria will be
selected by the central data administration of PoZoB after informed consent of
their GP. The GP will check the list on exclusion criteria. Eligible patients
will receive written information by mail. Within three weeks, they will be
contacted by phone whether they agree to participate. The participants will
have an appointment at the GP office and sign an informed consent. They will
have an interview of 45 - 60 minutes during which questionnaires regarding
medical history, signs and symptoms of HF, quality of life and symptoms of
depression and anxiety will be assessed. Moreover, the blood pressure will be
assessed twice, as well as BMI and waist circumference. After the intake, a
second appointment will be planned at the GP office for blood assessment, an
echocardiogram and an electrocardiogram.

All data will be evaluated by an independent cardiologist, who will advise the
GP about the outcome. The GP will receive a written summary. Besides, the GP
will be offered to discuss the outcome of the screening during an appointment
with the independent cardiologist.
After the screening, all patients who give informed consent will be followed by
questionnaires at 6,12, 18 and 24 months. Moreover, the biological outcome
parameters of the HT patients within the CVRM POZOB program will be followed.

The risks for the participants are considered minimal. The progression of heart
failure of patients at risk often goes unnoticed. Given the impact of serious
harftalen and given the fact that early intervention (medication adjustment en
possibly surgery in severe valvular heart disease) prevents further
progression, it is to justify that a relatively patient friendly intervention
(venipuncture, cardiac echo and ECG) is performed.