Heart FailureNCT01821638
Brain Alterations and Cognitive Impairment in Older Adults With Heart Failure
An observational study of Heart Failure, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Cognitive impairment, commonly reported as difficulty with memory and executive function, is a widely recognized clinical challenge for older persons with heart failure (HF). Little is known about the relationship between brain MRI and cognitive impairment in older persons with HF. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Heart Failure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2013to 31 Dec 2018
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Older adults with heart failure
Who may be able to join
- 65 years old or older
- English speaking and writing;
- Stable guideline based medication regimen for at least four weeks prior to enrollment
- New York Heart Association classification I-IV
Who cannot join
- Mini-Mental Status Exam score equal to or less than 24;
- Current diagnosis of neurological illnesses or movement disorders (e.g. Alzheimer's dementia, Parkinson's disease, Epilepsy);
- History of substance abuse/treatment;
- Untreated depression
- History of stroke;
- Hepatic insufficiency;
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- Severe renal failure;
- Untreated anemia;
- Left ventricular assist device;
- History of the following within three months of study enrollment: acute myocardial infarction, unstable angina, coronary artery bypass surgery, percutaneous transluminal angioplasty, or biventricular pacemaker insertion;
- History of implantable device (or other MRI contraindications).
- Prisoners
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Cognitive impairment, commonly reported as difficulty with memory and executive function, is a widely recognized clinical challenge for older persons with heart failure (HF). Little is known about the relationship between brain 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. Previous findings are limited by use of lower resolution scanners (1.5 Tesla), lack of MRI techniques (i.e. combining structural sequences with perfusion sequences) and recruitment of mixed age samples. Based on these limitations, the purpose of this research plan is to explore the relationship 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 age > 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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Keywords
- Heart failure, Cognition, Brain, Older adults
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older adults with heart failure | Older adults with heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean neuropsychological test scores and brain changes
Compare mean values of the following outcomes between older adults with heart failure and older adults without heart failure at baseline
- neuropsychological test scores
- brain medial temporal lobe volume
- brain frontal cortex volume
- brain medial temporal lobe perfusion
- brain frontal cortex perfusion
Compare mean value changes in the following outcomes between baseline and one year in patients with heart failure:
- neuropsychological test scores
- brain medial temporal lobe volume
- brain frontal cortex volume
- brain medial temporal lobe perfusion
- brain frontal cortex perfusion
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study start1 Apr 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Lisa C Bratzke, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821638
- Sponsor's protocol ID
- 2012-1064
- Status last verified
- Feb 2019
- First submitted
- 20 Mar 2013
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Alterations and Cognitive Impairment in Older Adults With Heart Failure
- ClinicalTrials.gov ID
- NCT01821638
- Acronym / sponsor ID
- 2012-1064
- Conditions
- Heart Failure
- Keywords
- Heart failure, Cognition, Brain, Older adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Apr 2013 (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.
Cognitive impairment, commonly reported as difficulty with memory and executive function, is a widely recognized clinical challenge for older persons with heart failure (HF). Little is known about the relationship between brain 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. Previous findings are limited by use of lower resolution scanners (1.5 Tesla), lack of MRI techniques (i.e. combining structural sequences with perfusion sequences) and recruitment of mixed age samples. Based on these limitations, the purpose of this research plan is to explore the relationship 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 age > 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults with heart failure | – | –Older adults with heart failure |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults with heart failure
Key inclusion criteria (4 listed)
- 65 years old or older
- English speaking and writing;
- Stable guideline based medication regimen for at least four weeks prior to enrollment
- New York Heart Association classification I-IV
Key exclusion criteria (13 listed)
- Mini-Mental Status Exam score equal to or less than 24;
- Current diagnosis of neurological illnesses or movement disorders (e.g. Alzheimer's dementia, Parkinson's disease, Epilepsy);
- History of substance abuse/treatment;
- Untreated depression
- History of stroke;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean neuropsychological test scores and brain changes
Time frame: One year
Compare mean values of the following outcomes between older adults with heart failure and older adults without heart failure at baseline * neuropsychological test scores * brain medial temporal lobe volume * brain frontal cortex volume * brain medial temporal lobe perfusion * brain frontal cortex perfusion Compare mean value changes in the following outcomes between baseline and one year in patients with heart failure: * neuropsychological test scores * brain medial temporal lobe volume * brain frontal cortex volume * brain medial temporal lobe perfusion * brain frontal cortex perfusion
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 6 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Lisa C Bratzke, PhD principal investigator
University of Wisconsin, Madison
1 site 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, run by University of Wisconsin, Madison at 1 site in United States.
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 4 inclusion and 13 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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Mean neuropsychological test scores and brain changes (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2019.