NCT00837889

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

August 11, 2025

Status Verified

November 1, 2010

Enrollment Period

1.8 years

First QC Date

February 3, 2009

Last Update Submit

August 8, 2025

Conditions

Keywords

cognitiondecompensationheart failurerecompensation

Outcome Measures

Primary Outcomes (3)

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

    within 48h of hospitalisation

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

    individual time to recompensate

  • differences in cognitive performance between decompensated heart failure patients, patients with chronic heart failure and healthy controls

    14 months (+/-2 month)

Secondary Outcomes (2)

  • all cause mortality

    12 month

  • long-term development of cognitive functioning in patients with heart failure after acute decompensation

    3, 6, 12 and 18 months after acute decompensation

Study Arms (3)

decompensated heart failure patients

Drug: diuretics, inotropica

chronic heart failure patients

healthy controls

Interventions

decompensated heart failure patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

university hospital, saarland

You may qualify if:

  • decompensated heart failure patients
  • NYHA III-IV
  • ejection fraction \< 35%

You may not qualify if:

  • psychosis
  • dementia
  • major depression
  • reanimation (\<3month)
  • patients with assist device system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Cardiology, University of the Saarland

Homburg, Saarland, 66421, Germany

Location

Developmental Psychology Unit, Saarland University

Saarbrücken, Saarland, 66111, Germany

Location

Related Publications (1)

  • Kindermann I, Fischer D, Karbach J, Link A, Walenta K, Barth C, Ukena C, Mahfoud F, Kollner V, Kindermann M, Bohm M. Cognitive function in patients with decompensated heart failure: the Cognitive Impairment in Heart Failure (CogImpair-HF) study. Eur J Heart Fail. 2012 Apr;14(4):404-13. doi: 10.1093/eurjhf/hfs015.

    PMID: 22431406BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Heart FailureCognitive Dysfunction

Interventions

Diuretics

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Natriuretic AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Michael Böhm, MD

    University Hospital, Saarland

    PRINCIPAL INVESTIGATOR
  • Ingrid Kindermann, MD

    University Hospital, Saarland

    PRINCIPAL INVESTIGATOR
  • Denise Fischer, Psychologist

    University Hospital, Saarland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 6, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2010

Study Completion

May 1, 2011

Last Updated

August 11, 2025

Record last verified: 2010-11

Locations