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

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ClinicalTrials.gov Identifier: NCT02226770
Recruitment Status : Unknown
Verified August 2014 by Fischer, University Hospital, Saarland.
Recruitment status was:  Recruiting
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Collaborator:
Friede Springer Herz Stiftung
Information provided by (Responsible Party):
Fischer, 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).

Condition or disease Intervention/treatment Phase
Heart Failure Patients Before and After ICD Implantation Device: Implantable Cardioverter Defibrillator (ICD) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Heart-focused Anxiety in Patients With Implantable Cardioverter Defibrillator (ICD) and/or Mechanical Cardiovascular Assist Device (AD) (Anxiety-CHF)
Study Start Date : July 2010
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ICD
Implantation of an Implantable Cardioverter Defibrillator (ICD) in patients with heart failure
Device: Implantable Cardioverter Defibrillator (ICD)



Primary Outcome Measures :
  1. Extent of heart-focused anxiety before and change after ICD implantation [ Time Frame: 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.

  2. Extent of general anxiety and depression before and change after ICD implantation [ Time Frame: 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.


  3. Quality of life before and change after ICD implantation [ Time Frame: 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.


  4. Number of patients affected by PTSD before and after ICD implantation [ Time Frame: 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.



Secondary Outcome Measures :
  1. Impact of type D personality on heart-focused anxiety [ Time Frame: 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.

  2. Impact of type D personality on general anxiety and depression [ Time Frame: 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.

  3. Impact of type D personality on quality of life. [ Time Frame: 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.

  4. Impact of type D personality on PTSD. [ Time Frame: 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.

  5. Impact of type D personality on numbers of shocks. [ Time Frame: 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.

  6. Impact of type D Personality on rehospitalization and morbidity. [ Time Frame: 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.


  7. Influence of heart-focused anxiety on rehospitalization and morbidity [ Time Frame: 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.


  8. Influence of general anxiety and depression in rehospitalization and morbidity [ Time Frame: 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.


  9. Influence of quality of life on rehospitalization and morbidity [ Time Frame: 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.

  10. Effect of ICD-shocks on heart-focused anxiety and effect of heart-focused anxiety on frequency of shocks [ Time Frame: 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.


  11. Effect of ICD-shocks on general anxiety and depression and effect of general anxiety and depression on frequency of shocks [ Time Frame: 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.


  12. Effect of ICD-shocks on quality of life and effect of quality of life on frequency of shocks [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • heart failure, indication for an implantable Cardioverter Defibrillator

Exclusion Criteria:

  • psychosis; advanced dementia; drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226770


Contacts
Contact: Ingrid Kindermann, PD Dr. med. 0049-6841-1623282 ingrid.kindermann@uks.eu

Locations
Germany
Saarland University Hospital Recruiting
Homburg, Saarland, Germany, 66421
Contact: Ingrid Kindermann, PD Dr. med.    0049-6841-1623282    ingrid.kindermann@uks.eu   
Principal Investigator: Ingrid Kindermann, PD Dr. med.         
Sponsors and Collaborators
University Hospital, Saarland
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fischer, Dr. rer. med. Dipl.-Psych., University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT02226770     History of Changes
Other Study ID Numbers: 252/12
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases