Heart Failure Patients Before and After ICD ImplantationAnxiety-CHFNCT02226770
Heart-focused Anxiety in Patients With Heart Failure and ICD
A study testing Implantable Cardioverter Defibrillator (ICD) in people with Heart Failure Patients Before and After ICD Implantation, run by University Hospital, Saarland at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure Patients Before and After ICD Implantation
- What is being tested?
- Implantable Cardioverter Defibrillator (ICD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jul 2010to 28 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- heart failure, indication for an implantable Cardioverter Defibrillator
Who cannot join
- psychosis; advanced dementia; drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Implantable Cardioverter Defibrillator (ICD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardioverter Defibrillator (ICD)Device
| Study group | Role | What they receive |
|---|---|---|
| ICD | Other | Implantation of an Implantable Cardioverter Defibrillator (ICD) in patients with heart failure Receives: Device: Implantable Cardioverter Defibrillator (ICD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline before ICD implantation to 24 months after implantation
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 24 months after implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study start14 Jul 2010
- Primary completion28 Oct 2016
- Study completion28 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure Patients Before and After ICD ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Collaborators
- Friede Springer Herz Stiftung
- Responsible party
- Principal investigator, Ingird Kindermann (PD Dr. med), University Hospital, Saarland
- Investigators
- Ingrid Kindermann, PD Dr. med., Principal investigator, Saarland University HospitalDenise Lenski, Dr. rer. nat. Dipl.-Psych., Principal investigator, Saarland University HospitalMaxie Bunz, Dipl.-Psych., Principal investigator, Saarland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226770
- Sponsor's protocol ID
- 252/12
- Acronym
- Anxiety-CHF
- Status last verified
- Oct 2021
- First submitted
- 17 Apr 2014
- Last updated
- 3 Nov 2021
- Results posted
- No
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.
PubMed 26481915
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart-focused Anxiety in Patients With Implantable Cardioverter Defibrillator (ICD) and/or Mechanical Cardiovascular Assist Device (AD) (Anxiety-CHF)
- ClinicalTrials.gov ID
- NCT02226770
- Acronym / sponsor ID
- Anxiety-CHF / 252/12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Collaborators
- Friede Springer Herz Stiftung
- Study start
- 14 Jul 2010 (actual)
- Primary completion
- 28 Oct 2016 (actual)
- Study completion
- 28 Oct 2016 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD | Other | Device: Implantable Cardioverter Defibrillator (ICD)Implantation of an Implantable Cardioverter Defibrillator (ICD) in patients with heart failure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- heart failure, indication for an implantable Cardioverter Defibrillator
Key exclusion criteria (1 listed)
- psychosis; advanced dementia; drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Cardioverter Defibrillator (ICD) | Device | ICD |
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.
12 secondary outcomes
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
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.
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.
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.
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.
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..
Influence of heart-focused anxiety on rehospitalization and morbidity
Time frame: Baseline to 24 months after implantation.
Influence of general anxiety and depression in rehospitalization and morbidity
Time frame: Baseline to 24 months after implantation.
Influence of quality of life on rehospitalization and morbidity
Time frame: Baseline to 24 months after implantation.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Derived from this study: PubMed 26481915Bunz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Kindermann, PD Dr. med. principal investigator
Saarland University Hospital
Denise Lenski, Dr. rer. nat. Dipl.-Psych. principal investigator
Saarland University Hospital
Maxie Bunz, Dipl.-Psych. principal investigator
Saarland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Cardioverter Defibrillator (ICD) in people with Heart Failure Patients Before and After ICD Implantation, run by University Hospital, Saarland at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of heart-focused anxiety before and change after ICD implantation (time frame: From baseline before ICD implantation to 24 months after implantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02226770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.