Cognitive Impairment in Patients With Heart Failure

Heart Failure Clinical Trial

— CogImpairHF  

Official title:

Cognitive Impairment and Prognosis in Patients With Decompensated Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00837889
• Other study ID #: 164/08
• Status: Active, not recruiting
• Phase: N/A
• First received: February 3, 2009
• Last updated: November 4, 2010
• Start date: January 2009
• Est. completion date: May 2011

Study information

• Verified date: November 2010
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Criteria of decompensated heart failure patients

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Heart Failure

Intervention

Drug:
• diuretics, inotropica

Locations

Country	Name	City	State
Germany	Department of Cardiology, University of the Saarland	Homburg	Saarland
Germany	Developmental Psychology Unit, Saarland University	Saarbruecken	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive function in decompensated heart failure patients measured by a cognitive test battery		within 48h of hospitalisation	No
Primary	cognitive function before and after medical recompensation measured by a cognitive test battery		individual time to recompensate	No
Primary	differences in cognitive performance between decompensated heart failure patients, patients with chronic heart failure and healthy controls			No
Secondary	all cause mortality		12 month	No
Secondary	long-term development of cognitive functioning in patients with heart failure after acute decompensation		3, 6, 12 and 18 months after acute decompensation	No