Heart-focused Anxiety in Patients With Heart Failure and ICD

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Heart Failure Patients Before and After ICD Implantation

Intervention / Treatment
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* Device: Implantable Cardioverter Defibrillator (ICD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: heart failure, indication for an implantable Cardioverter Defibrillator Exclusion Criteria: psychosis; advanced dementia; drug abuse
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ICD<br>Implantation of an Implantable Cardioverter Defibrillator (ICD) in patients with heart failure | Device: Implantable Cardioverter Defibrillator (ICD)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of heart-focused anxiety before and change after ICD implantation | 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. | From baseline before ICD implantation to 24 months after implantation | 
| Extent of general anxiety and depression before and change after ICD 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. | From baseline before ICD implantation to 24 months after implantation | 
| Quality of life before and change after ICD 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. | From baseline before ICD implantation to 24 months after implantation | 
| Number of patients affected by PTSD before and after ICD 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. | From baseline before ICD implantation to 24 months after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of type D personality on heart-focused anxiety | 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 | 
| Impact of type D personality on general anxiety and depression | 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. | 
| Impact of type D personality on quality of life. | 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. | 
| Impact of type D personality on PTSD. | 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. | 
| Impact of type D personality on numbers of shocks. | Type D ist measured with the DS14. ICD-shocks will be measured as number of shocks per patient. | For type D: Baseline and for number of shocks: from ICD implantation to 24 months after implantation. | 
| Impact of type D Personality on rehospitalization and morbidity. | 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.. | 
| Influence of heart-focused anxiety on rehospitalization and morbidity | 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. | Baseline to 24 months after implantation. | 
| Influence of general anxiety and depression in rehospitalization and morbidity | 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. | Baseline to 24 months after implantation. | 
| Influence of quality of life on rehospitalization and morbidity | 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. | Baseline to 24 months after implantation. | 
| 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. | Baseline to 24 months after implantation. | 
| 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. | Baseline to 24 months after implantation. | 
| Effect of ICD-shocks on quality of life and effect of quality of life on frequency of shocks | Quality of life will be measured as stated in the primary outcomes section. ICD-shocks will be measured as number of shocks per patient. | Baseline to 24 months after implantation. |