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Completed

NCT Number: NCT00837889

Cognitive Impairment in Patients With Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Heart Diseases Mental Disorders Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, University of the Saarland, Homburg, Saarland, Germany

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About this study

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:

  • Identifying specific cognitive impairments in patients with congestive heart failure compared to healthy controls
  • Evaluating the influence of acute decompensation in congestive heart failure on cognitive functioning
  • Investigating the effects of medical treatment on cognitive functioning in patients with decompensated heart failure
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diuretics, inotropica

Drug

Primary outcomes

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

    Time frame: within 48h of hospitalisation

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

    Time frame: individual time to recompensate

  3. 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

  1. all cause mortality

    Time frame: 12 month

  2. 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

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Official study title

Cognitive Impairment and Prognosis in Patients With Decompensated Heart Failure

Acronym: CogImpairHF

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Feb 6, 2009
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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