Completed

Brain MRI and Cognitive Function in Older Adults with Heart Failure

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Study Aim

This observational study aims to compare brain MRI and cognitive function between older adults with heart failure and those without, focusing on changes in neuropsychological test scores, brain medial temporal lobe volume, brain frontal cortex volume, and brain perfusion in these regions at baseline and after one year.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

From 65 to 85 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity of Wisconsin, Madison
Last updated: February 6, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

Cognitive impairment, commonly reported as difficulty with memory and executive function, is a widely recognized clinical challenge for persons > 65 years old with HF. Although the degree of cognitive impairment usually does not meet the criteria for dementia, it can affect an individual's ability to process and remember information, such as complex medication regimens [5]. Findings suggest that brain regions that support memory (i.e. temporal lobe) and executive function (i.e. prefrontal cortex) may be altered in older persons with HF; suggesting that these brain alterations are related to the HF disease process and not normal aging. Surprisingly, despite the high prevalence of cognitive impairment in HF, relationships between brain and cognition have not been well studied. Little is known about the relationships between brain magnetic resonance imaging (MRI) and cognitive impairment in older persons with HF. A limited number of studies have investigated brain MRI in adults with HF and produced conflicting results. Three studies utilized structural MRI techniques and identified evidence of atrophy in the temporal lobe, hippocampus, and prefrontal cortex and an increased volume of white matter hyperintensities [6-8]. Brain hypoperfusion, operationalized as decreased global cerebral perfusion, was identified in two studies [9, 10]. Only one study examined relationships between brain MRI and cognitive impairment in HF [6]. Vogels et al., (2007) found that atrophy in the medial temporal lobe was associated with decreased measures of memory and executive function. White matter hyperintensities did not correlate with any cognitive measures. Limited research findings indicate that various brain alterations in the temporal lobe, hippocampus, and prefrontal cortex contribute to cognitive impairment in HF. However, previous findings are limited by use of lower resolution scanners (1.5 Tesla), lack of MRI techniques (i.e. structural and perfusion scans) and recruitment of mixed age samples. Based on these limitations, the purpose of this research plan is to explore relationships between brain MRI and cognitive impairment in older persons with HF using high resolution structural and perfusion scans. To accomplish this goal, investigators will compare 40 adults with HF who are > 65 years old with 40 healthy, gender, age, and education matched controls. Investigators will obtain neuropsychological measures of multiple domains, as well as MRI measurements of the temporal lobe and prefrontal cortex at baseline and 12-months. The following specific aims will be investigated: Aim 1: Compare brain MRI in older persons with HF and controls at baseline and 12-months. Hypothesis 1a: Older persons with HF will have increased white matter hyperintensities, decreased grey matter volume, and decreased perfusion in the temporal lobe and prefrontal cortex compared with controls. Hypothesis 1b: Older persons with HF will exhibit a greater decline in grey matter volume in the temporal lobe and prefrontal cortex over 12-months compared with controls. Aim 2: Compare cognitive function in older persons with HF and controls at baseline and 12-months. Hypothesis 2a): Older persons with HF will perform lower on measures of memory and executive function compared with controls. Hypothesis 2b): Older persons with HF will exhibit a greater decline on measures of memory and executive function over 12-months compared with controls. Aim 3: Examine the relationships between brain MRI and cognitive function in older persons with HF and controls at baseline. Hypothesis 3a: Decreased grey matter and perfusion in the temporal lobe and an increased volume of white matter hyperintensities in the temporal lobe will be associated with decreased memory scores. Hypothesis 3b: Decreased grey matter and perfusion in the prefrontal cortex and an increased volume of white matter hyperintensities in the prefrontal cortex will be associated with a decreased executive function score.

Principal SponsorUniversity of Wisconsin, Madison
Last updated: February 6, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 65 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Failure

Criteria

4 inclusion criteria required to participate
65 years old or older

English speaking and writing

New York Heart Association classification I-IV

Stable guideline based medication regimen for at least four weeks prior to enrollment

13 exclusion criteria prevent from participating
Current diagnosis of neurological illnesses or movement disorders (e.g. Alzheimer's dementia, Parkinson's disease, Epilepsy)

Hepatic insufficiency

History of implantable device (or other MRI contraindications)

History of stroke

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Wisconsin Hospital and Clinics

Madison, United StatesOpen University of Wisconsin Hospital and Clinics in Google Maps
CompletedOne Study Center