Heart-focused Anxiety in Patients With Heart Failure and ICD

Heart Failure Patients Before and After ICD Implantation Clinical Trial

— Anxiety-CHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226770
• Other study ID #: 252/12
• Status: Completed
• Phase: N/A
• Start date: July 14, 2010
• Est. completion date: October 28, 2016

Study information

• Verified date: October 2021
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 28, 2016
• Est. primary completion date: October 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• heart failure, indication for an implantable Cardioverter Defibrillator

Exclusion Criteria:

• psychosis; advanced dementia; drug abuse

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Patients Before and After ICD Implantation

Intervention

Device:
• Implantable Cardioverter Defibrillator (ICD)

Locations

Country	Name	City	State
Germany	Saarland University Hospital	Homburg	Saarland

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Saarland	Friede Springer Herz Stiftung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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..
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.