Brain Alterations and Cognitive Impairment in Older Adults with Heart Failure
Brain Alterations and Cognitive Impairment in Older Adults with Heart Failure
Overall Status:
Recruiting
Brief Description:
Cognitive impairment is a widely recognized problem in older adults with heart failure, but little is known about specific brain changes in this population. In this observational study, researchers will study the relationship between brain-scan (MRI) results and cognitive impairment in older people with heart failure and without dementia.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
65 Years | 85 Years | Both | No |
Inclusion Criteria:
- Diagnosis of heart failure, as defined by New York Heart Association classification I-IV
- Ability to speak and write in English
- Stable medication regimen for at least 4 weeks prior to enrollment
Exclusion Criteria:
- Mini-Mental Status Exam score of 24 or less
- Current diagnosis of neurological illness or movement disorder (for example, Alzheimer's dementia, Parkinson's disease, epilepsy)
- History of substance abuse or substance-abuse treatment
- Untreated depression
- History of stroke
- Hepatic insufficiency, severe renal failure, or untreated anemia
- Left ventricular assist device
- History of the following within 3 months of study enrollment: acute myocardial infarction, unstable angina, coronary artery bypass surgery, percutaneous transluminal angioplasty, or biventricular pacemaker insertion
- History of pacemaker, metal implants, or other conditions that would prevent MRI
- Pregnancy
Detailed Description:
Cognitive impairment is a widely recognized problem in older adults with heart failure, yet little is known about the exact relationship between physical brain changes and cognitive changes in this population. In this study, researchers will examine the results of MRI brain scans in adults 65 and older with heart failure to determine how they relate to changes in cognition. Investigators will compare 40 adults with heart failure with 40 healthy controls. Participants will undergo MRI brain scans and neuropsychological tests during 1 year.
Investigators hypothesize that older adults with heart failure will have certain brain changes compared with controls, specifically, increased white matter hyperintensities, decreased grey matter volume, and decreased perfusion in the temporal lobe and prefrontal cortex. They predict that these changes will correlate with poorer performance on tests of memory and executive function by the participants with heart failure, compared with controls.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 43.0772547, -89.430773 | University of Wisconsin | Madison | Wisconsin | 53792 | Recruiting |
Lead Sponsor:
| Agency |
|---|
University of Wisconsin, Madison |
Collaborator Sponsor:
| Agency |
|---|
National Institutes of Health (NIH) |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Lisa C. Bratzke, PhD | Principal Investigator | University of Wisconsin, Madison |
Study Contact:
| Name | Phone | |
|---|---|---|
Lisa C. Bratzke, PhD | 608-263-5277 |
Locations
ClinicalTrials.gov ID
NCT01821638 (follow link to view full record on ct.gov in new window)
Official Title:
Brain Alterations and Cognitive Impairment in Older Adults With Heart Failure
Study Start Date:
April 2013
Study End Date:
February 2016
Disease Stage:
Pre-clinical
Enrollment:
47
