Heart FailureCogImpairHFNCT00837889
Cognitive Impairment in Patients With Heart Failure
An observational study of Heart Failure and Cognitive Impairment, run by Universität des Saarlandes at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Cognitive Impairment
- What is being tested?
- diuretics, inotropica
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2009to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: university hospital, saarland
Who may be able to join
- decompensated heart failure patients
- NYHA III-IV
- ejection fraction < 35%
Who cannot join
- psychosis
- dementia
- major depression
- reanimation (<3month)
- patients with assist device system
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Cardiology, University of the Saarland
Homburg, Saarland, 66421
Developmental Psychology Unit, Saarland University
Saarbrücken, Saarland, 66111
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Heart Failure, Cognitive Impairment
- Being tested
- diuretics, inotropica
- Keywords
- cognition, decompensation, heart failure, recompensation
- Medical subject headings
- Heart Failure, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diuretics, inotropicaDrug
| Study group | Role | What they receive |
|---|---|---|
| decompensated heart failure patients | Not described Receives: Drug: diuretics, inotropica | |
| chronic heart failure patients | Not described | |
| healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function in decompensated heart failure patients measured by a cognitive test battery
Measured: within 48h of hospitalisation
cognitive function before and after medical recompensation measured by a cognitive test battery
Measured: individual time to recompensate
differences in cognitive performance between decompensated heart failure patients, patients with chronic heart failure and healthy controls
Measured: 14 months (+/-2 month)
Secondary outcomes (2)
all cause mortality
Measured: 12 month
long-term development of cognitive functioning in patients with heart failure after acute decompensation
Measured: 3, 6, 12 and 18 months after acute decompensation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Böhm, MD, Principal investigator, University Hospital, SaarlandIngrid Kindermann, MD, Principal investigator, University Hospital, SaarlandDenise Fischer, Psychologist, Principal investigator, University Hospital, Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837889
- Sponsor's protocol ID
- 164/08
- Acronym
- CogImpairHF
- Status last verified
- Nov 2010
- First submitted
- 3 Feb 2009
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22431406
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment and Prognosis in Patients With Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT00837889
- Acronym / sponsor ID
- CogImpairHF / 164/08
- Conditions
- Heart Failure, Cognitive Impairment
- Keywords
- cognition, decompensation, heart failure, recompensation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| decompensated heart failure patients | – | Drug: diuretics, inotropica |
| chronic heart failure patients | – | – |
| healthy controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- university hospital, saarland
Key inclusion criteria (3 listed)
- decompensated heart failure patients
- NYHA III-IV
- ejection fraction < 35%
Key exclusion criteria (5 listed)
- psychosis
- dementia
- major depression
- reanimation (<3month)
- patients with assist device system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diuretics, inotropica | Drug | decompensated heart failure patients |
Primary outcome
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: 14 months (+/-2 month)
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Results publication: PubMed 22431406Kindermann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Böhm, MD principal investigator
University Hospital, Saarland
Ingrid Kindermann, MD principal investigator
University Hospital, Saarland
Denise Fischer, Psychologist principal investigator
University Hospital, Saarland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cognitive Impairment, run by Universität des Saarlandes at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function in decompensated heart failure patients measured by a cognitive test battery (time frame: within 48h of hospitalisation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00837889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.