Study Results
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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COMPLETED
60 participants
OBSERVATIONAL
2009-01-31
2011-05-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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decompensated heart failure patients
diuretics, inotropica
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
Eligibility Criteria
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Inclusion Criteria
* NYHA III-IV
* ejection fraction \< 35%
Exclusion Criteria
* dementia
* major depression
* reanimation (\<3month)
* patients with assist device system
18 Years
ALL
Yes
Sponsors
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Universität des Saarlandes
OTHER
Responsible Party
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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
Developmental Psychology Unit, Saarland University
Saarbrücken, Saarland, Germany
Countries
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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.
Other Identifiers
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164/08
Identifier Type: -
Identifier Source: org_study_id
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