Cognitive Impairment in Patients With Heart Failure (CogImpairHF)
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
university hospital, saarland
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| Germany | |
| Department of Cardiology, University of the Saarland | |
| Homburg, Saarland, Germany, 66421 | |
| Developmental Psychology Unit, Saarland University | |
| Saarbruecken, Saarland, Germany, 66111 | |
| 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 Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013