Heart FailureMIND-HFNCT02572648
A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls
An observational study of Heart Failure, run by Emory University at 3 sites in United States.
Trial summary
The purpose of this study is to examine the relation between the structural brain changes associated with heart failure, neurocognitive performance, and how these changes impact self-care behaviors. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Brain Imaging (Neuroimaging) and Cognitive Function Assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2015to Aug 2017
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women with heart failure and men and women without heart failure to serve as healthy age-matched controls.
Who may be able to join
- Participants with heart failure:
- Speak and understand English
- Live independently within a 60 mile radius of Atlanta
- Montreal Cognitive Assessment (MOCA) score of less than or equal to 24
- Documented medical diagnosis of New York Heart Association (NYHA) class II or III systolic
- Left ventricular ejection fraction (LVEF) greater than or equal to 10% that is documented within the last year by echocardiogram, cardiac catheterization ventriculography, or radionuclide ventriculography
Show all 10Show fewer
- Receiving medication therapy for heart failure (HF) according to American College of Cardiology (ACC) American Heart recommendation guidelines for at least 8 weeks prior to study enrollment
- Healthy Controls
- Speak and understand English
- Live independently within a 60 mile radius of Atlanta
Who cannot join
- Participants with heart failure:
- New York Heart Association (NYHA) class I or IV
- Change in heart failure (HF) therapy within 6 months
- Worsening of heart failure (HF) symptoms within last 5 days
- Unstable angina
- Renal insufficiency (serum creatinine greater than 3.o mg/dL)
Show all 22Show fewer
- Hospitalized within the last 30-days
- Diagnosed with any neurological disorder that may interfere with cognitive function
- Beck Depression Inventory II (BDI-II) score greater than 25
- Claustrophobia
- Implanted devices such as internal cardiac defibrillator or pacemaker
- Carrying non-removable objects
- Stents
- Body weight more than 120 kg
- Healthy Controls
- Taking prescription medications
- Cardiovascular disease;
- Cerebrovascular disease
- Neurological disease
- Respiratory disease
- Claustrophobia
- Any implanted metal objects not considered safe or appropriate for the MRI environment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
The Emory Clinic
Atlanta, Georgia, 30322
Emory St. Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)
The purpose of this study is to examine the relation between the structural brain changes associated with heart failure, neurocognitive performance, and how these changes impact self-care behaviors.
Read the detailed description
The purpose of this study is use neuroimaging techniques to better understand the underlying structural brain changes and physiological mechanisms that guide the thinking and decision making processes required for people with heart failure. The study will compare how the underlying brain structures and circulation are similar to or different in persons with heart failure to healthy, aged matched controls using special neuroimaging procedures.
- Conditions
- Heart Failure
- Being tested
- Brain Imaging (Neuroimaging), Cognitive Function Assessment
- Keywords
- Cardiomyopathy, Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Imaging (Neuroimaging)Other
Magnetic Resonance Imaging (MR) will be acquired on a research dedicated Siemens 3Tesla TIM TRIO MRI scanner with a 32-channel head coil.The MRI scanning protocol will have scans to measure voxelwise and whole-brain measures of grey matter (GM) volumes through a high resolution T1-weighted (T1W) multi-echo magnetization prepared gradient echo (MEMPRAGE) anatomic scan.
Total time in scanner will be approximately 53 minutes.
Cognitive Function AssessmentOther
Cognitive function will be assessed using several batteries; the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Controlled Oral Word Association Test (COWA), the Color Trails 1 \& 2, the WAIS-III Digit Span and Letter Number Sequence test, the Stroop Test, and the California Computerized Assessment Package Reaction Time test (CALCAP).
| Study group | Role | What they receive |
|---|---|---|
| Participants with Heart Failure | Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI). Receives: Other: Brain Imaging (Neuroimaging); Other: Cognitive Function Assessment | |
| Healthy Controls | Healthy controls will complete neurocognitive tests and undergo magnetic resonance imaging (MRI). Receives: Other: Brain Imaging (Neuroimaging); Other: Cognitive Function Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural White Matter
Diffusion tensor imaging (DTI) and myelin water imaging (MWI) will be used to compare brain structural white matter between participants with heart failure and healthy controls. This will be obtained via magnetic resonance imaging (MRI) techniques.
Measured: Visit 1 (Up to 2 hours)
Secondary outcomes (14)
Functional Connectivity
Functional connectivity that regulates neurocognitive functions will be assessed by blood oxygen level dependent resting state functional MRI (rsFMRI).This will be obtained via magnetic resonance imaging (MRI) techniques.
Measured: Visit 1 (Up to 2 hours)
Global Cerebral Blood Flow (CBF)
Arterial spin labeling (ASL) based magnetic resonance (MR) perfusion imaging will evaluate global cerebral blood flow (CBF). This will be obtained via magnetic resonance imaging (MRI) techniques.
Measured: Visit 1 (Up to 2 hours)
Regional Cerebral Blood Flow (CBF)
Arterial spin labeling (ASL) based magnetic resonance (MR) perfusion imaging will evaluate regional cerebral blood flow (CBF). This will be obtained via magnetic resonance imaging (MRI) techniques.
Measured: Visit 1 (Up to 2 hours)
Structural Grey Matter
Voxel-based morphometry (VBM) of T1-weighted (T1w) high-resolution magnetic resonance imaging MRI anatomics will be used to measure brain structural white matter.
Measured: Visit 1 (Up to 2 hours)
Cognitive Function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
Measured: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Controlled Oral Word Association (COWA) Test
The Controlled Oral Word Association (COWA) Test is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. The more words produced in the allotted time period the higher the score.
Measured: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Color Trails Test
The Color Trails Test measures sustained attention and sequencing. For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.
Measured: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Digit Span Test
The Wechsler Adult Intelligence Scale-III (WAIS-III) Digit Span Test measures short-term memory, attention, and concentration. Participants will be asked to repeat 3 - 9 digits forward and 2 - 9 digits backwards.
Measured: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Letter Number Sequence Test
During the Wechsler Adult Intelligence Scale-III (WAIS-III) Letter Number Sequence Test, participants will be presented with combinations of letters and numbers, (two to nine letter-number combinations). Participants will be asked to repeat each series by, first, repeating the numbers in ascending order, then the letters in alphabetical order. The test measures working memory or the ability to simultaneously recall and organize stimuli of different and similar types
Measured: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Stroop Test
The Stroop Test measure a person's selective attention capacity and skills, as well as their processing speed ability.It is used to examine a person's executive processing abilities. The Stroop Test during brain imaging studies is used to investigate regions of the brain that are involved in planning, decision-making, and managing real-world interference
Measured: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the California Computerized Assessment Package (CALCAP)
The California Computerized Assessment Package assesses reaction times, speed of information processing, rapid visual scanning, form discrimination, brief memory and divided attention.
Measured: Visit 2 (Up to 2 hours)
Self-Management assessed by the Self-care Index Heart Failure (SCHFI)
The Self-care Index Heart Failure (SCHFI) is a measure designed to assess self-care maintenance, management, and confidence. Participants will be asked to recall feelings of the aforementioned in the last three months.
Measured: Visit 2 (Up to 2 hours)
Peak oxygen consumption assessed by the Modified Balke Test
Peaked oxygen consumption will be assessed by the Modified Balke Test. Participants will be asked to walk on a slightly inclined treadmill. The amount of oxygen consumed will be measured while walking for up to ten minutes.
Measured: Visit 2 (Up to 2 hours)
Quality of Life assessed by the Kansas City Cardiomyopathy Questionnaire
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
Measured: Visit 2 (Up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2017
- Study completionAug 2017
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 Emory UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Rebecca Gary, Emory University
- Investigators
- Rebecca Gary, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572648
- Sponsor's protocol ID
- IRB00083607
- Acronym
- MIND-HF
- Status last verified
- Sep 2017
- First submitted
- 7 Oct 2015
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)
- ClinicalTrials.gov ID
- NCT02572648
- Acronym / sponsor ID
- MIND-HF / IRB00083607
- Conditions
- Heart Failure
- Keywords
- Cardiomyopathy, Magnetic Resonance Imaging (MRI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Oct 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 9 Oct 2015 (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 purpose of this study is to examine the relation between the structural brain changes associated with heart failure, neurocognitive performance, and how these changes impact self-care behaviors.
Detailed description
The purpose of this study is use neuroimaging techniques to better understand the underlying structural brain changes and physiological mechanisms that guide the thinking and decision making processes required for people with heart failure. The study will compare how the underlying brain structures and circulation are similar to or different in persons with heart failure to healthy, aged matched controls using special neuroimaging procedures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Heart Failure | – | Other: Brain Imaging (Neuroimaging), Other: Cognitive Function AssessmentParticipants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI). |
| Healthy Controls | – | Other: Brain Imaging (Neuroimaging), Other: Cognitive Function AssessmentHealthy controls will complete neurocognitive tests and undergo magnetic resonance imaging (MRI). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women with heart failure and men and women without heart failure to serve as healthy age-matched controls.
Key inclusion criteria (10 listed)
- Speak and understand English
- Live independently within a 60 mile radius of Atlanta
- Montreal Cognitive Assessment (MOCA) score of less than or equal to 24
- Documented medical diagnosis of New York Heart Association (NYHA) class II or III systolic
- Left ventricular ejection fraction (LVEF) greater than or equal to 10% that is documented within the last year by echocardiogram, cardiac catheterization ventriculography, or radionuclide ventriculography
Key exclusion criteria (22 listed)
- New York Heart Association (NYHA) class I or IV
- Change in heart failure (HF) therapy within 6 months
- Worsening of heart failure (HF) symptoms within last 5 days
- Unstable angina
- Renal insufficiency (serum creatinine greater than 3.o mg/dL)
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 |
|---|---|---|
| Brain Imaging (Neuroimaging)Magnetic Resonance Imaging (MR) will be acquired on a research dedicated Siemens 3Tesla TIM TRIO MRI scanner with a 32-channel head coil.The MRI scanning protocol will have scans to measure voxelwise and whole-brain measures of grey matter (GM) volumes through a high resolution T1-weighted (T1W) multi-echo magnetization prepared gradient echo (MEMPRAGE) anatomic scan. Total time in scanner will be approximately 53 minutes. | Other | Healthy Controls, Participants with Heart Failure |
| Cognitive Function AssessmentCognitive function will be assessed using several batteries; the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Controlled Oral Word Association Test (COWA), the Color Trails 1 \& 2, the WAIS-III Digit Span and Letter Number Sequence test, the Stroop Test, and the California Computerized Assessment Package Reaction Time test (CALCAP). | Other | Healthy Controls, Participants with Heart Failure |
Primary outcome
Structural White Matter
Time frame: Visit 1 (Up to 2 hours)
Diffusion tensor imaging (DTI) and myelin water imaging (MWI) will be used to compare brain structural white matter between participants with heart failure and healthy controls. This will be obtained via magnetic resonance imaging (MRI) techniques.
14 secondary outcomes
Functional Connectivity
Time frame: Visit 1 (Up to 2 hours)
Global Cerebral Blood Flow (CBF)
Time frame: Visit 1 (Up to 2 hours)
Regional Cerebral Blood Flow (CBF)
Time frame: Visit 1 (Up to 2 hours)
Structural Grey Matter
Time frame: Visit 1 (Up to 2 hours)
Cognitive Function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Controlled Oral Word Association (COWA) Test
Time frame: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Color Trails Test
Time frame: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Digit Span Test
Time frame: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Letter Number Sequence Test
Time frame: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Stroop Test
Time frame: Visit 2 (Up to 2 hours)
Cognitive Function assessed by the California Computerized Assessment Package (CALCAP)
Time frame: Visit 2 (Up to 2 hours)
Self-Management assessed by the Self-care Index Heart Failure (SCHFI)
Time frame: Visit 2 (Up to 2 hours)
Peak oxygen consumption assessed by the Modified Balke Test
Time frame: Visit 2 (Up to 2 hours)
Quality of Life assessed by the Kansas City Cardiomyopathy Questionnaire
Time frame: Visit 2 (Up to 2 hours)
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 21 Sep 2017.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Rebecca Gary principal investigator
Emory University
3 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, run by Emory University at 3 sites 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 10 inclusion and 22 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 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Structural White Matter (time frame: Visit 1 (Up to 2 hours)). 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 21 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.