The Influence of Psychological Factors on Health Outcomes in Patients Treated with Cardiac Resynchronization Therapy: A Prospective, Single-Center, Observational Study.

Cardiac resynchronization therapy with defibrillator (CRT-D) is a promising
treatment in congestive heart failure (CHF), both in terms of improving
functional status and quality of life and in reducing mortality and morbidity.
However, despite proven benefits, a subgroup of patients (20-30%) still report
impaired quality of life and functional status following CRT, which cannot be
explained solely by traditional objective indicators of CHF severity. A paucity
of studies have examined the role of psychological factors in predicting health
outcomes, such as quality of life and morbidity, in patients treated with
CRT-D. In addition, little is known about the relationship between
psychological factors and cytokine activation in heart failure.

Primary
1. To examine whether psychological factors moderate the effect of the
objectively assessed clinical CRT-D response on quality of life in patients
with CHF.

Secondary
2. To examine whether psychological factors moderate the effect of the
objectively assessed clinical CRT-D response on morbidity in patients with CHF.
3. To investigate whether the relationship between Type D personality and
2-year mortality and morbidity in CHF patients treated with CRT-D is mediated
by cytokine activation.

Prospective, observational, single-centre study, with a 2-year follow-up.
Psychological assessments will take place at 5 time points during a period of
12 months. At visits to the outpatient clinic, patients will undergo standard
medical tests, give blood for the determination of cytokine activation, and
complete a set of standardized and validated questionnaires. Information on
medical characteristics and adverse clinical events during the 2-year follow-up
period will be retrieved from the patients* medical records.

The proposed study incurs no extra risk to patients, as they receive no
additional treatment and/or tests nor will any treatment be withheld from them
compared to patients who choose not to participate or are excluded on the basis
of the exclusion criteria. No extra venapuncture will take place, as the extra
blood samples for the study will be taken at the time of the standard
assessments for the clinical management of patients. The only burden to
patients is the time that it will take to complete a set of psychological
questionnaires at the clinical follow-up visits, which is estimated to take 1
hour. Given that patients often have to wait for the different tests and
appointments with various professionals at the outpatient clinic, the
questionnaires can be completed during this waiting period.