Heart-focused Anxiety in Patients With Heart Failure and ICD

Not Applicable

Completed

• Conditions: Heart Failure Patients Before and After ICD Implantation
• Interventions: Device: Implantable Cardioverter Defibrillator (ICD)

• Registration Number: NCT02226770
• Lead Sponsor: University Hospital, Saarland

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-07-14
• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-27
• Primary Completion: 2016-10-28
• Study Completion: 2016-10-28
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• heart failure, indication for an implantable Cardioverter Defibrillator

Exclusion Criteria

• psychosis; advanced dementia; drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICD	Implantable Cardioverter Defibrillator (ICD)	Implantation of an Implantable Cardioverter Defibrillator (ICD) in patients with heart failure

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Impact of type D personality on heart-focused anxiety	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 Type D Scale-14 (DS14). Heart-focused anxiety is measured as stated in the primary outcome measures section.
Influence of general anxiety and depression in rehospitalization and morbidity	Baseline to 24 months after implantation.	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.
Influence of quality of life on rehospitalization and morbidity	Baseline to 24 months after implantation.	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	Baseline to 24 months after implantation.	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	Baseline to 24 months after implantation.	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.
Impact of type D personality on numbers of shocks.	For type D: Baseline and for number of shocks: from ICD implantation to 24 months after implantation.	Type D ist measured with the DS14. ICD-shocks will be measured as number of shocks per patient.
Impact of type D Personality on rehospitalization and morbidity.	For type D: Baseline and for rehospitalization and morbidity: from implantation until 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.
Effect of ICD-shocks on quality of life and effect of quality of life on frequency of shocks	Baseline to 24 months after implantation.	Quality of life will be measured as stated in the primary outcomes section. ICD-shocks will be measured as number of shocks per patient.
Impact of type D personality on quality of life.	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. Quality of life is measured as stated in the primary outcome measures section.
Impact of type D personality on general anxiety and depression	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. General anxiety and depression are measured as stated in the primary outcome measures section.
Impact of type D personality on PTSD.	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.
Influence of heart-focused anxiety on rehospitalization and morbidity	Baseline to 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.

Trial Locations

Locations (1)

Saarland University Hospital; 🇩🇪 Homburg, Saarland, Germany