PSYCHE-ICD study
(Psychiatric SYmptoms in Congestive Heart failure: Evaluation in ICD recipients)

The number of patients suffering from heart failure is steadily increasing in
Western civilized countries, amongst others due to the introduction of the
implantable cardioverter defibrillator (ICD). The ICD has had a major impact on
survival and, as a consequence, on treatment of patients with ischemic and non
ischemic cardiomyopathy (CMP). Prevention of SCD by means of an ICD has been
implemented for this population in the ACC/AHA/ESC guidelines, resulting in an
exponential growth in ICD implantations and concomitant costs. However, only
35% of implanted patients receive ICD therapy for a life threatening
ventricular arrhythmia during the first three years of follow up. As the
majority of patients remains free from ICD therapy, a further refinement of
criteria is needed to select those patients who are most likely to benefit from
this treatment modality.

Currently, effort is put into the development of enhanced risk stratification
methods which assess myocardial electrical instability (e.g. microvolt T-wave
alternans, signal averaged electrocardiogram and more recently short-term
variability of repolarization duration), and indicators of pathophysiological
substrates related to electrical instability (e.g. scar burden, ischemia,
altered mechanical function, and innervation defects). Over the last decade,
however, a growing interest has developed for the interplay between
psychological status and heart failure, leading to the notion that the presence
of psychological disorders -especially depression and anxiety- might
significantly affect disease burden and prognosis in heart failure.

Several mechanisms have been proposed connecting these psychiatric disorders to
somatic effects in heart failure patients. The most important are 1).
Sympathetic * parasympathetic dysbalanceand 2). Inflammation. Unraveling these
relationships might open new possibilities for selection of patients at
increased risk for ventricular tachyarrhythmias. In addition, it may aid in
development of novel treatment options for this patient group both in
cardiological and psychiatric directions thus relieving disease burden and
improving quality of life. The present study is designed to investigate the
aforementioned interplay in heart failure patients eligible for ICD
implantation.

Study hypothesis
We hypothesize that :
1). CHF patients suffering from depression or anxiety disorders are at
increased risk for adverse outcome, in particular for ventricular
tachyarrhythmias.
2). the interplay between depression or anxiety and poor CHF prognosis is
related to both sympathetic-parasympathetic dysbalance and inflammatory status.
3). for a subset of patients the ICD implantation, either by itself or due to
therapy (*shocks*) administered by the device, results in development of
symptoms of depression or anxiety. The likelihood of symptom development
depends on type of personality.

The primary objective of the study is to relate depression and anxiety in CHF
patients receiving an ICD to the occurrence of ventricular tachyarrhythmias.

Secondary objectives of the study are:
Assessment of the effects of depression and anxiety on
- Worsening heart failure
- Mortality
- Occurrence of atrial tachyarrhythmias
Assessment of the relations between depression and anxiety, CHF (in particular
ventricular tachyarrhythmias) and:
- the sympathetic system
- inflammatory response
Assessment of the effects of device implantation and device therapy (*shocks*)
on depression and anxiety

This is a single center prospective multecenter observational study. The period
of observation is set to 3 years.

The burden of participation in this study is estimated to be low.
- Study visits are only scheduled together with regular follow up visits. No
additional visits are planned.
- A study visit will take approximately an additional 60-90 minutes (30-45
minutes for questionnaire, 30 minutes for additional somatic assessment, 30
mintues for a test that registers the hartrhythm and blood pressure by doing a
few simple exercises (autonomic function testing) and ECG.
- Additional blood tests will only be taken when a regular follow up
venapuncture is performed (i.e. additional blood drawn, but no additional
venapunctures). At baseline and after 1 year an extra blood tube will be taken
for biomarkers (sorry material). Separate informed consent is possible.
- At baseline and after 1 year a hairsample will be taken(from the head) is
taken (separate informed consent possilbe).
- An ECG of 4 min. will take place annually.

The risk of participation in this study is estimated to be extremely low (no
known possible adverse effects).