Cognitive Impairment in Patients With Heart Failure (CogImpairHF)
Recruitment status was Active, not recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Cognitive Impairment and Prognosis in Patients With Decompensated Heart Failure|
- cognitive function in decompensated heart failure patients measured by a cognitive test battery [ Time Frame: within 48h of hospitalisation ] [ Designated as safety issue: No ]
- cognitive function before and after medical recompensation measured by a cognitive test battery [ Time Frame: individual time to recompensate ] [ Designated as safety issue: No ]
- differences in cognitive performance between decompensated heart failure patients, patients with chronic heart failure and healthy controls [ Designated as safety issue: No ]
- all cause mortality [ Time Frame: 12 month ] [ Designated as safety issue: No ]
- long-term development of cognitive functioning in patients with heart failure after acute decompensation [ Time Frame: 3, 6, 12 and 18 months after acute decompensation ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||May 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
|decompensated heart failure patients||Drug: diuretics, inotropica|
|chronic heart failure patients|
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.
- Identifying specific cognitive impairments in patients with congestive heart failure compared to healthy controls
- Evaluating the influence of acute decompensation in congestive heart failure on cognitive functioning
- Investigating the effects of medical treatment on cognitive functioning in patients with decompensated heart failure
- Exploring long-term effects of cognitive and physiological status on hospitalisation and/or mortality
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837889
|Department of Cardiology, University of the Saarland|
|Homburg, Saarland, Germany, 66421|
|Developmental Psychology Unit, Saarland University|
|Saarbruecken, Saarland, Germany, 66111|
|Principal Investigator:||Michael Böhm, MD||University Hospital, Saarland|
|Principal Investigator:||Ingrid Kindermann, MD||University Hospital, Saarland|
|Principal Investigator:||Denise Fischer, Psychologist||University Hospital, Saarland|