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Clinical Trials/NCT00837889
NCT00837889
Completed
N/A

Cognitive Impairment and Prognosis in Patients With Decompensated Heart Failure

Universität des Saarlandes2 sites in 1 country60 target enrollmentJanuary 1, 2009

Overview

Phase
N/A
Intervention
diuretics, inotropica
Conditions
Heart Failure
Sponsor
Universität des Saarlandes
Enrollment
60
Locations
2
Primary Endpoint
cognitive function in decompensated heart failure patients measured by a cognitive test battery
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2009
End Date
May 1, 2011
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • psychosis
  • major depression
  • reanimation (\<3month)
  • patients with assist device system

Arms & Interventions

decompensated heart failure patients

Intervention: diuretics, inotropica

Outcomes

Primary Outcomes

cognitive function in decompensated heart failure patients measured by a cognitive test battery

Time Frame: within 48h of hospitalisation

cognitive function before and after medical recompensation measured by a cognitive test battery

Time Frame: individual time to recompensate

differences in cognitive performance between decompensated heart failure patients, patients with chronic heart failure and healthy controls

Time Frame: 14 months (+/-2 month)

Secondary Outcomes

  • long-term development of cognitive functioning in patients with heart failure after acute decompensation(3, 6, 12 and 18 months after acute decompensation)
  • all cause mortality(12 month)

Study Sites (2)

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