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Heart-focused Anxiety in Patients With Heart Failure and ICD

NCT ID: NCT02226770

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-14

Study Completion Date

2016-10-28

Brief Summary

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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

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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

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Heart Failure Patients Before and After ICD Implantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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ICD

Implantation of an Implantable Cardioverter Defibrillator (ICD) in patients with heart failure

Group Type OTHER

Implantable Cardioverter Defibrillator (ICD)

Intervention Type DEVICE

Interventions

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Implantable Cardioverter Defibrillator (ICD)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* heart failure, indication for an implantable Cardioverter Defibrillator

Exclusion Criteria

* psychosis; advanced dementia; drug abuse
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Friede Springer Herz Stiftung

UNKNOWN

Sponsor Role collaborator

University Hospital, Saarland

OTHER

Sponsor Role lead

Responsible Party

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Ingird Kindermann (PD Dr. med)

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingrid Kindermann, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Saarland University Hospital

Denise Lenski, Dr. rer. nat. Dipl.-Psych.

Role: PRINCIPAL_INVESTIGATOR

Saarland University Hospital

Maxie Bunz, Dipl.-Psych.

Role: PRINCIPAL_INVESTIGATOR

Saarland University Hospital

Locations

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Saarland University Hospital

Homburg, Saarland, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 26481915 (View on PubMed)

Other Identifiers

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252/12

Identifier Type: -

Identifier Source: org_study_id