Cognitive Impairment in Patients With Heart Failure

• Conditions: Cognitive Impairment; Heart Failure
• Interventions: Drug: diuretics, inotropica

• Registration Number: NCT00837889
• Lead Sponsor: University Hospital, Saarland

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Last Update Submitted: 2010-11-04
• Last Update Posted: 2010-11-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
decompensated heart failure patients	diuretics, inotropica	-

Primary Outcome Measures

Name	Time	Method
cognitive function in decompensated heart failure patients measured by a cognitive test battery	within 48h of hospitalisation
differences in cognitive performance between decompensated heart failure patients, patients with chronic heart failure and healthy controls
cognitive function before and after medical recompensation measured by a cognitive test battery	individual time to recompensate

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Developmental Psychology Unit, Saarland University; 🇩🇪 Saarbruecken, Saarland, Germany

Department of Cardiology, University of the Saarland; 🇩🇪 Homburg, Saarland, Germany