NCT02226770

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2010

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2016

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

Enrollment Period

6.3 years

First QC Date

April 17, 2014

Last Update Submit

October 27, 2021

Conditions

Heart Failure Patients Before and After ICD Implantation

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    From baseline before ICD implantation to 24 months after implantation

Secondary Outcomes (12)

  • Impact of type D personality on heart-focused anxiety

    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

    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.

    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.

    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.

    For type D: Baseline and for number of shocks: from ICD implantation to 24 months after implantation.

  • +7 more secondary outcomes

Study Arms (1)

ICD

OTHER

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

Device: Implantable Cardioverter Defibrillator (ICD)

Interventions

Implantable Cardioverter Defibrillator (ICD)DEVICE
ICD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • heart failure, indication for an implantable Cardioverter Defibrillator

You may not qualify if:

  • psychosis; advanced dementia; drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saarland University Hospital

Homburg, Saarland, 66421, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26481915DERIVED

MeSH Terms

Interventions

Defibrillators, Implantable

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Ingrid Kindermann, PD Dr. med.

    Saarland University Hospital

    PRINCIPAL INVESTIGATOR

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

    Saarland University Hospital

    PRINCIPAL INVESTIGATOR

  • Maxie Bunz, Dipl.-Psych.

    Saarland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

April 17, 2014

First Posted

August 27, 2014

Study Start

July 14, 2010

Primary Completion

October 28, 2016

Study Completion

October 28, 2016

Last Updated

November 3, 2021

Record last verified: 2021-10

Locations

DE(1)