<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02226770</url>
  </required_header>
  <id_info>
    <org_study_id>252/12</org_study_id>
    <nct_id>NCT02226770</nct_id>
  </id_info>
  <brief_title>Heart-focused Anxiety in Patients With Heart Failure and ICD</brief_title>
  <acronym>Anxiety-CHF</acronym>
  <official_title>Heart-focused Anxiety in Patients With Implantable Cardioverter Defibrillator (ICD) and/or Mechanical Cardiovascular Assist Device (AD) (Anxiety-CHF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Saarland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Friede Springer Herz Stiftung</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universität des Saarlandes</source>
  <brief_summary>
    <textblock>
      The aim of the present study is to measure heart-focused anxiety, general anxiety,&#xD;
      depression, PTSD and quality of life as well as type D personality in patients with heart&#xD;
      failure before and after the implantation of a cardioverter defibrillator (ICD) and/or assist&#xD;
      device (AD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients with heart failure and implantable Cardioverter Defibrillator (ICD) psychological&#xD;
      comorbidities such as heart focused anxiety and depression often occur. These psychological&#xD;
      factors may have negative effects on compliance as well as on the development of the cardiac&#xD;
      disease and therefore on rehospitalization and mortality rates.&#xD;
&#xD;
      A personality structure where negative affect is paired with social inhibition (the inability&#xD;
      to communicate ones feelings to others) can often be found in patients with cardiovascular&#xD;
      disease. This so-called type D personality is also associated with a worse prognosis.&#xD;
&#xD;
      It is of interest whether, and if so in what way, the implantation of an ICD can affect the&#xD;
      psychological well-being and through that the prognosis of the heart failure patient.&#xD;
&#xD;
      The goal of this study is therefore to investigate the effect of ICD implantation on&#xD;
      heart-focused anxiety, depression, possible traumatization and quality of life in patients&#xD;
      with heart failure with consideration of a possible moderating effect of the type D&#xD;
      personality.&#xD;
&#xD;
      Furthermore, the impact of the above stated psychological factors on rehospitalization and&#xD;
      mortality, as well as on frequency of shocks shall be examined.&#xD;
&#xD;
      Vice versa, the frequency of shocks or the impact of being shocked at all on psychological&#xD;
      factors is of interest.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2010</start_date>
  <completion_date type="Actual">October 28, 2016</completion_date>
  <primary_completion_date type="Actual">October 28, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Extent of heart-focused anxiety before and change after ICD implantation</measure>
    <time_frame>From baseline before ICD implantation to 24 months after implantation</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Extent of general anxiety and depression before and change after ICD implantation</measure>
    <time_frame>From baseline before ICD implantation to 24 months after implantation</time_frame>
    <description>General anxiety and depression are recorded with the Hospital Anxiety and Depression Scale.&#xD;
All questionnaires will be filled out at baseline (before device implantation) as well as 5, 12 and 24 months after implantation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life before and change after ICD implantation</measure>
    <time_frame>From baseline before ICD implantation to 24 months after implantation</time_frame>
    <description>Quality of life is documented through the Minnesota Living With Heart Failure Questionnaire.&#xD;
All questionnaires will be filled out at baseline (before device implantation) as well as 5, 12 and 24 months after implantation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients affected by PTSD before and after ICD implantation</measure>
    <time_frame>From baseline before ICD implantation to 24 months after implantation</time_frame>
    <description>The Impact of Event Scale (revised) is used to evaluate the possibility of a post-traumatic stress disorder (PTSD).&#xD;
All questionnaires will be filled out at baseline (before device implantation) as well as 5, 12 and 24 months after implantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of type D personality on heart-focused anxiety</measure>
    <time_frame>For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation</time_frame>
    <description>Type D ist measured with the Type D Scale-14 (DS14). Heart-focused anxiety is measured as stated in the primary outcome measures section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of type D personality on general anxiety and depression</measure>
    <time_frame>For type D: Baseline and for the psychological variables: from baseline before ICD implantation to 24 months after implantation.</time_frame>
    <description>Type D ist measured with the DS14. General anxiety and depression are measured as stated in the primary outcome measures section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of type D personality on quality of life.</measure>
    <time_frame>For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation.</time_frame>
    <description>Type D ist measured with the DS14. Quality of life is measured as stated in the primary outcome measures section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of type D personality on PTSD.</measure>
    <time_frame>For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation.</time_frame>
    <description>Type D ist measured with the DS14. PTSD is measured as stated in the primary outcome measures section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of type D personality on numbers of shocks.</measure>
    <time_frame>For type D: Baseline and for number of shocks: from ICD implantation to 24 months after implantation.</time_frame>
    <description>Type D ist measured with the DS14. ICD-shocks will be measured as number of shocks per patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of type D Personality on rehospitalization and morbidity.</measure>
    <time_frame>For type D: Baseline and for rehospitalization and morbidity: from implantation until 24 months after implantation..</time_frame>
    <description>Type D ist measured with the DS14. Psychological factors will be measured as stated in the primary outcomes section.&#xD;
Rehospitalization will be measured as number of times of readmission and mortality will be measured in total numbers of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of heart-focused anxiety on rehospitalization and morbidity</measure>
    <time_frame>Baseline to 24 months after implantation.</time_frame>
    <description>Heart-focused anxiety will be measured as stated in the primary outcomes section.&#xD;
Rehospitalization will be measured as number of times of readmission and mortality will be measured in total numbers of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of general anxiety and depression in rehospitalization and morbidity</measure>
    <time_frame>Baseline to 24 months after implantation.</time_frame>
    <description>General anxiety and depression will be measured as stated in the primary outcomes section.&#xD;
Rehospitalization will be measured as number of times of readmission and mortality will be measured in total numbers of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of quality of life on rehospitalization and morbidity</measure>
    <time_frame>Baseline to 24 months after implantation.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of ICD-shocks on heart-focused anxiety and effect of heart-focused anxiety on frequency of shocks</measure>
    <time_frame>Baseline to 24 months after implantation.</time_frame>
    <description>Heart-focused anxiety will be measured as stated in the primary outcomes section.&#xD;
ICD-shocks will be measured as number of shocks per patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of ICD-shocks on general anxiety and depression and effect of general anxiety and depression on frequency of shocks</measure>
    <time_frame>Baseline to 24 months after implantation.</time_frame>
    <description>General anxiety and depression will be measured as stated in the primary outcomes section.&#xD;
ICD-shocks will be measured as number of shocks per patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of ICD-shocks on quality of life and effect of quality of life on frequency of shocks</measure>
    <time_frame>Baseline to 24 months after implantation.</time_frame>
    <description>Quality of life will be measured as stated in the primary outcomes section. ICD-shocks will be measured as number of shocks per patient.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Heart Failure Patients Before and After ICD Implantation</condition>
  <arm_group>
    <arm_group_label>ICD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Implantation of an Implantable Cardioverter Defibrillator (ICD) in patients with heart failure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantable Cardioverter Defibrillator (ICD)</intervention_name>
    <arm_group_label>ICD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  heart failure, indication for an implantable Cardioverter Defibrillator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychosis; advanced dementia; drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingrid Kindermann, PD Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saarland University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Denise Lenski, Dr. rer. nat. Dipl.-Psych.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saarland University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maxie Bunz, Dipl.-Psych.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saarland University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saarland University Hospital</name>
      <address>
        <city>Homburg</city>
        <state>Saarland</state>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>April 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>October 27, 2021</last_update_submitted>
  <last_update_submitted_qc>October 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Saarland</investigator_affiliation>
    <investigator_full_name>Ingird Kindermann (PD Dr. med)</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02226770
org study id: 252/12
nct id: NCT02226770
lead sponsor: 
collaborator: 
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).
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Extent of heart-focused anxiety before and change after ICD implantation
time frame: From baseline before ICD implantation to 24 months after implantation
description: 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.
measure: Extent of general anxiety and depression before and change after ICD implantation
time frame: From baseline before ICD implantation to 24 months after implantation
description: 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.
measure: Quality of life before and change after ICD implantation
time frame: From baseline before ICD implantation to 24 months after implantation
description: 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.
measure: Number of patients affected by PTSD before and after ICD implantation
time frame: From baseline before ICD implantation to 24 months after implantation
description: 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.
measure: 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
description: Type D ist measured with the Type D Scale-14 (DS14). Heart-focused anxiety is measured as stated in the primary outcome measures section.
measure: 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.
description: Type D ist measured with the DS14. General anxiety and depression are measured as stated in the primary outcome measures section.
measure: 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.
description: Type D ist measured with the DS14. Quality of life is measured as stated in the primary outcome measures section.
measure: 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.
description: Type D ist measured with the DS14. PTSD is measured as stated in the primary outcome measures section.
measure: 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.
description: Type D ist measured with the DS14. ICD-shocks will be measured as number of shocks per patient.
measure: 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..
description: 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.
measure: Influence of heart-focused anxiety on rehospitalization and morbidity
time frame: Baseline to 24 months after implantation.
description: 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.
measure: Influence of general anxiety and depression in rehospitalization and morbidity
time frame: Baseline to 24 months after implantation.
description: 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.
measure: Influence of quality of life on rehospitalization and morbidity
time frame: Baseline to 24 months after implantation.
description: 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.
measure: 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.
description: Heart-focused anxiety will be measured as stated in the primary outcomes section.
ICD-shocks will be measured as number of shocks per patient.
measure: 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.
description: 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.
measure: 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.
description: Quality of life will be measured as stated in the primary outcomes section. ICD-shocks will be measured as number of shocks per patient.
arm group label: ICD
arm group type: Other
description: Implantation of an Implantable Cardioverter Defibrillator (ICD) in patients with heart failure
intervention type: Device
intervention name: Implantable Cardioverter Defibrillator (ICD)
arm group label: ICD
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ingrid Kindermann, PD Dr. med.
role: Principal Investigator
affiliation: Saarland University Hospital
last name: Denise Lenski, Dr. rer. nat. Dipl.-Psych.
role: Principal Investigator
affiliation: Saarland University Hospital
last name: Maxie Bunz, Dipl.-Psych.
role: Principal Investigator
affiliation: Saarland University Hospital
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Saarland
investigator full name: Ingird Kindermann (PD Dr. med)
investigator title: Prof. Dr. med.
mesh term: Heart Failure