Cognitive Impairment in Patients With Heart Failure (CogImpairHF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University Hospital, Saarland.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00837889
First received: February 3, 2009
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Heart Failure
Cognitive Impairment
Drug: diuretics, inotropica

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cognitive Impairment and Prognosis in Patients With Decompensated Heart Failure

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • cognitive function in decompensated heart failure patients measured by a cognitive test battery [ Time Frame: within 48h of hospitalisation ] [ Designated as safety issue: No ]
  • cognitive function before and after medical recompensation measured by a cognitive test battery [ Time Frame: individual time to recompensate ] [ Designated as safety issue: No ]
  • differences in cognitive performance between decompensated heart failure patients, patients with chronic heart failure and healthy controls [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • all cause mortality [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
decompensated heart failure patients Drug: diuretics, inotropica
chronic heart failure patients
healthy controls

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

university hospital, saarland

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837889

Locations
Germany
Department of Cardiology, University of the Saarland
Homburg, Saarland, Germany, 66421
Developmental Psychology Unit, Saarland University
Saarbruecken, Saarland, Germany, 66111
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Principal Investigator: Michael Böhm, MD University Hospital, Saarland
Principal Investigator: Ingrid Kindermann, MD University Hospital, Saarland
Principal Investigator: Denise Fischer, Psychologist University Hospital, Saarland
  More Information

No publications provided

Responsible Party: Prof. Dr. Michael Böhm, Department of Cardiology, University of the Saarland
ClinicalTrials.gov Identifier: NCT00837889     History of Changes
Other Study ID Numbers: 164/08
Study First Received: February 3, 2009
Last Updated: November 4, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Saarland:
cognition
decompensation
heart failure
recompensation

Additional relevant MeSH terms:
Heart Failure
Cognition Disorders
Heart Diseases
Cardiovascular Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014