NCT02226770

Heart-focused Anxiety in Patients With Heart Failure and ICD

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: University Hospital, Saarland · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure Patients Before and After ICD Implantation

Interventions

Type	Name	Description
DEVICE	Implantable Cardioverter Defibrillator (ICD)

Timeline

• Start date: 2010-07-14
• Primary completion: 2016-10-28
• Completion: 2016-10-28
• First posted: 2014-08-27
• Last updated: 2021-11-03

Locations

1 site across 1 country: Germany