Cognitive Impairment in Patients With Heart Failure (CogImpairHF)

August 8, 2025 updated by: Universität des Saarlandes

Cognitive Impairment and Prognosis in Patients With Decompensated 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Department of Cardiology, University of the Saarland
      • Saarbruecken, Saarland, Germany, 66111
        • Developmental Psychology Unit, Saarland University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

university hospital, saarland

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy controls
decompensated heart failure patients
Drug: diuretics, inotropica
chronic heart failure patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cognitive function in decompensated heart failure patients measured by a cognitive test battery
Time Frame: within 48h of hospitalisation
within 48h of hospitalisation
cognitive function before and after medical recompensation measured by a cognitive test battery
Time Frame: individual time to recompensate
individual time to recompensate
differences in cognitive performance between decompensated heart failure patients, patients with chronic heart failure and healthy controls
Time Frame: 14 months (+/-2 month)
14 months (+/-2 month)

Secondary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: 12 month
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
3, 6, 12 and 18 months after acute decompensation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität des Saarlandes

Investigators

  • Principal Investigator: Ingrid Kindermann, MD, University Hospital, Saarland
  • Principal Investigator: Denise Fischer, Psychologist, University Hospital, Saarland
  • Principal Investigator: Michael Böhm, MD, University Hospital, Saarland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimated)

February 6, 2009

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 8, 2025

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 164/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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