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).

Study Overview

• Status: Completed
• Conditions: Heart Failure Patients Before and After ICD Implantation
• Intervention / Treatment: Device: Implantable Cardioverter Defibrillator (ICD)

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 Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Saarland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• heart failure, indication for an implantable Cardioverter Defibrillator

Exclusion Criteria:

• psychosis; advanced dementia; drug abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: ICD; Implantation of an Implantable Cardioverter Defibrillator (ICD) in patients with heart failure	Device: Implantable Cardioverter Defibrillator (ICD)

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Hospital, Saarland
• Collaborators: Friede Springer Herz Stiftung
• Investigators: Principal Investigator: Ingrid Kindermann, PD Dr. med., Saarland University Hospital; Principal Investigator: Denise Lenski, Dr. rer. nat. Dipl.-Psych., Saarland University Hospital; Principal Investigator: Maxie Bunz, Dipl.-Psych., Saarland University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 14, 2010
• Primary Completion (ACTUAL): October 28, 2016
• Study Completion (ACTUAL): October 28, 2016

Study Registration Dates

• First Submitted: April 17, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (ESTIMATE): August 27, 2014

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 252/12