Clinical trial NCT02226770: Heart-focused Anxiety in Patients With Heart Failure and ICD
Official title: Heart-focused Anxiety in Patients With Implantable Cardioverter Defibrillator (ICD) and/or Mechanical Cardiovascular Assist Device (AD) (Anxiety-CHF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure Patients Before and After ICD Implantation
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: Friede Springer Herz Stiftung
First posted: 2014-08-27
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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).

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.

Eligibility criteria: Inclusion Criteria:

* heart failure, indication for an implantable Cardioverter Defibrillator

Exclusion Criteria:

* psychosis; advanced dementia; drug abuse

Primary outcomes:
measure: Extent of heart-focused anxiety before and change after ICD implantation
timeFrame: From baseline before ICD implantation to 24 months after implantation
measure: Extent of general anxiety and depression before and change after ICD implantation
timeFrame: From baseline before ICD implantation to 24 months after implantation
measure: Quality of life before and change after ICD implantation
timeFrame: From baseline before ICD implantation to 24 months after implantation
measure: Number of patients affected by PTSD before and after ICD implantation
timeFrame: From baseline before ICD implantation to 24 months after implantation
Secondary outcomes:
measure: Impact of type D personality on heart-focused anxiety
timeFrame: For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation
measure: Impact of type D personality on general anxiety and depression
timeFrame: For type D: Baseline and for the psychological variables: from baseline before ICD implantation to 24 months after implantation.
measure: Impact of type D personality on quality of life.
timeFrame: For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation.
measure: Impact of type D personality on PTSD.
timeFrame: For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation.
measure: Impact of type D personality on numbers of shocks.
timeFrame: For type D: Baseline and for number of shocks: from ICD implantation to 24 months after implantation.
measure: Impact of type D Personality on rehospitalization and morbidity.
timeFrame: For type D: Baseline and for rehospitalization and morbidity: from implantation until 24 months after implantation..
measure: Influence of heart-focused anxiety on rehospitalization and morbidity
timeFrame: Baseline to 24 months after implantation.
measure: Influence of general anxiety and depression in rehospitalization and morbidity
timeFrame: Baseline to 24 months after implantation.
measure: Influence of quality of life on rehospitalization and morbidity
timeFrame: Baseline to 24 months after implantation.
measure: Effect of ICD-shocks on heart-focused anxiety and effect of heart-focused anxiety on frequency of shocks
timeFrame: Baseline to 24 months after implantation.
measure: Effect of ICD-shocks on general anxiety and depression and effect of general anxiety and depression on frequency of shocks
timeFrame: Baseline to 24 months after implantation.
measure: Effect of ICD-shocks on quality of life and effect of quality of life on frequency of shocks
timeFrame: Baseline to 24 months after implantation.
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Saarland University Hospital
state: Saarland
Study officials:
affiliation: Saarland University Hospital
name: Ingrid Kindermann, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Saarland University Hospital
name: Denise Lenski, Dr. rer. nat. Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: Saarland University Hospital
name: Maxie Bunz, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.