Overview

This trial is active, not recruiting.

Conditions heart failure, cognitive impairment
Treatment diuretics, inotropica
Sponsor University Hospital, Saarland
Start date January 2009
End date November 2010
Trial size 60 participants
Trial identifier NCT00837889, 164/08

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
diuretics, inotropica

Primary Outcomes

Measure
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:

Secondary Outcomes

Measure
all cause mortality
time frame: 12 month
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Cognitive Impairment and Prognosis in Patients With Decompensated Heart Failure
Principal investigator Michael Böhm, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by University Hospital, Saarland.