Trial document




This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007262

Trial Description

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Title

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

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Trial Acronym

Anxiety-CHF

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URL of the Trial

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Brief Summary in Lay Language

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).

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00007262
  •   2016/02/26
  •   2014/04/17
  •   yes
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Secondary IDs

  •   NCT02226770  (ClinicalTrials.gov)
  •   252/12  (University Hospital, Saarland)
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Health Condition or Problem studied

  •   Heart Failure Patients Before and After ICD Implantation
  •   I50.9 -  Heart failure, unspecified
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Interventions/Observational Groups

  •   Device: Implantable Cardioverter Defibrillator (ICD)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
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Primary Outcome

- 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.
- 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.
- 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.
- 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.

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Secondary Outcome

- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2010/07/31
  •   100
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- heart failure, indication for an implantable Cardioverter Defibrillator

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Exclusion Criteria

- psychosis; advanced dementia; drug abuse

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Addresses

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    • University Hospital, Saarland
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    • Friede Springer Herz Stiftung
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    • Saarland University Hospital
    • Ingrid Kindermann, PD Dr. med. 
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    • Ingrid Kindermann, PD Dr. med. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.