Heart-focused Anxiety in Patients With Heart Failure and ICD (Anxiety-CHF)

Heart-focused Anxiety in Patients With Implantable Cardioverter Defibrillator (ICD) and/or Mechanical Cardiovascular Assist Device (AD) (Anxiety-CHF)

The aim of the present study is to measure heart-focused anxiety, general anxiety, depression, PTSD and quality of life as well as type D personality in patients with heart failure before and after the implantation of a cardioverter defibrillator (ICD) and/or assist device (AD).

In patients with heart failure and implantable Cardioverter Defibrillator (ICD) psychological comorbidities such as heart focused anxiety and depression often occur. These psychological factors may have negative effects on compliance as well as on the development of the cardiac disease and therefore on rehospitalization and mortality rates. A personality structure where negative affect is paired with social inhibition (the inability to communicate ones feelings to others) can often be found in patients with cardiovascular disease. This so-called type D personality is also associated with a worse prognosis. It is of interest whether, and if so in what way, the implantation of an ICD can affect the psychological well-being and through that the prognosis of the heart failure patient. The goal of this study is therefore to investigate the effect of ICD implantation on heart-focused anxiety, depression, possible traumatization and quality of life in patients with heart failure with consideration of a possible moderating effect of the type D personality. Furthermore, the impact of the above stated psychological factors on rehospitalization and mortality, as well as on frequency of shocks shall be examined. Vice versa, the frequency of shocks or the impact of being shocked at all on psychological factors is of interest.

Heart-focused anxiety is measured through the use of the Cardiac Anxiety Questionnaire. All questionnaires will be filled out at baseline (before device implantation) as well as 5, 12 and 24 months after implantation.

General anxiety and depression are recorded with the Hospital Anxiety and Depression Scale. All questionnaires will be filled out at baseline (before device implantation) as well as 5, 12 and 24 months after implantation.

Quality of life is documented through the Minnesota Living With Heart Failure Questionnaire. All questionnaires will be filled out at baseline (before device implantation) as well as 5, 12 and 24 months after implantation.

The Impact of Event Scale (revised) is used to evaluate the possibility of a post-traumatic stress disorder (PTSD). All questionnaires will be filled out at baseline (before device implantation) as well as 5, 12 and 24 months after implantation.

Type D ist measured with the Type D Scale-14 (DS14). Heart-focused anxiety is measured as stated in the primary outcome measures section.

For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation

Type D ist measured with the DS14. General anxiety and depression are measured as stated in the primary outcome measures section.

For type D: Baseline and for the psychological variables: from baseline before ICD implantation to 24 months after implantation.

Type D ist measured with the DS14. Quality of life is measured as stated in the primary outcome measures section.

For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation.

Type D ist measured with the DS14. PTSD is measured as stated in the primary outcome measures section.

For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation.

For type D: Baseline and for number of shocks: from ICD implantation to 24 months after implantation.

Type D ist measured with the DS14. Psychological factors will be measured as stated in the primary outcomes section. Rehospitalization will be measured as number of times of readmission and mortality will be measured in total numbers of patients.

For type D: Baseline and for rehospitalization and morbidity: from implantation until 24 months after implantation..

Heart-focused anxiety will be measured as stated in the primary outcomes section. Rehospitalization will be measured as number of times of readmission and mortality will be measured in total numbers of patients.

General anxiety and depression will be measured as stated in the primary outcomes section. Rehospitalization will be measured as number of times of readmission and mortality will be measured in total numbers of patients.

Quality of life will be measured as stated in the primary outcomes section. Rehospitalization will be measured as number of times of readmission and mortality will be measured in total numbers of patients.

Effect of ICD-shocks on heart-focused anxiety and effect of heart-focused anxiety on frequency of shocks

Heart-focused anxiety will be measured as stated in the primary outcomes section. ICD-shocks will be measured as number of shocks per patient.

Effect of ICD-shocks on general anxiety and depression and effect of general anxiety and depression on frequency of shocks

General anxiety and depression will be measured as stated in the primary outcomes section. ICD-shocks will be measured as number of shocks per patient.

Quality of life will be measured as stated in the primary outcomes section. ICD-shocks will be measured as number of shocks per patient.

Inclusion Criteria: heart failure, indication for an implantable Cardioverter Defibrillator Exclusion Criteria: psychosis; advanced dementia; drug abuse

Bunz M, Lenski D, Wedegartner S, Ukena C, Karbach J, Bohm M, Kindermann I. Heart-focused anxiety in patients with chronic heart failure before implantation of an implantable cardioverter defibrillator: baseline findings of the Anxiety-CHF Study. Clin Res Cardiol. 2016 Mar;105(3):216-24. doi: 10.1007/s00392-015-0909-1. Epub 2015 Oct 19.