Cognitive Impairment in Patients With Heart Failure

NCT ID: NCT00837889

Last Updated: 2025-08-11

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

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-05-31

Brief Summary

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The aim of the present study is threefold: investigating 1) specific cognitive impairments in patients with congestive heart failure, 2) whether cognitive impairments in patients with decompensated heart failure improve after medical recompensation and 3) whether cognitive functioning is related to the long-term prognosis (mortality, rehospitalisation) of those patients.

Detailed Description

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The daily routine in clinical settings often shows cognitive impairments in patients with congestive heart failure. Recent studies reported declines in cognitive functioning such as executive functions, episodic memory, perceptual speed and attention. However, less is known regarding the differential impairments of cognitive functioning in patients with decompensated heart failure.

Study objectives:

1. Identifying specific cognitive impairments in patients with congestive heart failure compared to healthy controls
2. Evaluating the influence of acute decompensation in congestive heart failure on cognitive functioning
3. Investigating the effects of medical treatment on cognitive functioning in patients with decompensated heart failure
4. Exploring long-term effects of cognitive and physiological status on hospitalisation and/or mortality

Study design:

Cognitive functions of patients with decompensated heart (NYHA III-IV) failure are compared to age and gender matched patients with congestive heart failure (NYHA III-IV) without symptoms of cardiac decompensation and with healthy controls. Decompensated patients are tested before and after medical recompensation. For matched patients and controls, the pretest-posttest timing is based on the recompensation time of the respective patient with decompensated heart failure.

The neuropsychological test battery includes measures of episodic memory, working memory, short-term memory, executive functions, perceptual speed and intelligence. In addition, the study applied standardized questionnaires of self assessed quality of life and depression. Relevant physiological data, such as left ventricular systolic function and N-terminal pro brain natriuretic peptide (NT-pro-BNP), are recorded.

Conditions

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Heart Failure Cognitive Impairment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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decompensated heart failure patients

diuretics, inotropica

Intervention Type DRUG

chronic heart failure patients

No interventions assigned to this group

healthy controls

No interventions assigned to this group

Interventions

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diuretics, inotropica

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* decompensated heart failure patients
* NYHA III-IV
* ejection fraction \< 35%

Exclusion Criteria

* psychosis
* dementia
* major depression
* reanimation (\<3month)
* patients with assist device system
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Böhm, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Saarland

Ingrid Kindermann, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Saarland

Denise Fischer, Psychologist

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Saarland

Locations

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Department of Cardiology, University of the Saarland

Homburg, Saarland, Germany

Site Status

Developmental Psychology Unit, Saarland University

Saarbrücken, Saarland, Germany

Site Status

Countries

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Germany

References

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Kindermann I, Fischer D, Karbach J, Link A, Walenta K, Barth C, Ukena C, Mahfoud F, Kollner V, Kindermann M, Bohm M. Cognitive function in patients with decompensated heart failure: the Cognitive Impairment in Heart Failure (CogImpair-HF) study. Eur J Heart Fail. 2012 Apr;14(4):404-13. doi: 10.1093/eurjhf/hfs015.

Reference Type BACKGROUND
PMID: 22431406 (View on PubMed)

Other Identifiers

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164/08

Identifier Type: -

Identifier Source: org_study_id

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