Clinical trial NCT00837889: Cognitive Impairment in Patients With Heart Failure
Official title: Cognitive Impairment and Prognosis in Patients With Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Cognitive Impairment
Keywords: cognition
decompensation
heart failure
recompensation
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2009-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Eligibility criteria: 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

Primary outcomes:
measure: cognitive function in decompensated heart failure patients measured by a cognitive test battery
timeFrame: within 48h of hospitalisation
measure: cognitive function before and after medical recompensation measured by a cognitive test battery
timeFrame: individual time to recompensate
measure: differences in cognitive performance between decompensated heart failure patients, patients with chronic heart failure and healthy controls
Secondary outcomes:
measure: all cause mortality
timeFrame: 12 month
measure: long-term development of cognitive functioning in patients with heart failure after acute decompensation
timeFrame: 3, 6, 12 and 18 months after acute decompensation
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Department of Cardiology, University of the Saarland
state: Saarland
city: Saarbruecken
country: Germany
facility: Developmental Psychology Unit, Saarland University
state: Saarland
Study officials:
affiliation: University Hospital, Saarland
name: Michael Böhm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Saarland
name: Ingrid Kindermann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Saarland
name: Denise Fischer, Psychologist
role: PRINCIPAL_INVESTIGATOR
References: