A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls

Completed

• Conditions: Heart Failure
• Interventions: Other: Brain Imaging (Neuroimaging); Other: Cognitive Function Assessment

• Registration Number: NCT02572648
• Lead Sponsor: Emory University

Brief 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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-09
• Primary Completion: 2017-06
• Study Completion: 2017-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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
• 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

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Exclusion Criteria

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)
• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Cognitive Function Assessment	Healthy controls will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
Participants with Heart Failure	Cognitive Function Assessment	Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
Healthy Controls	Brain Imaging (Neuroimaging)	Healthy controls will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
Participants with Heart Failure	Brain Imaging (Neuroimaging)	Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).

Primary Outcome Measures

Name	Time	Method
Structural White Matter	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.

Secondary Outcome Measures

Name	Time	Method
Functional Connectivity	Visit 1 (Up to 2 hours)	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.
Global Cerebral Blood Flow (CBF)	Visit 1 (Up to 2 hours)	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.
Regional Cerebral Blood Flow (CBF)	Visit 1 (Up to 2 hours)	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.
Structural Grey Matter	Visit 1 (Up to 2 hours)	Voxel-based morphometry (VBM) of T1-weighted (T1w) high-resolution magnetic resonance imaging MRI anatomics will be used to measure brain structural white matter.
Cognitive Function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Visit 2 (Up to 2 hours)	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.
Cognitive Function assessed by the Controlled Oral Word Association (COWA) Test	Visit 2 (Up to 2 hours)	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.
Cognitive Function assessed by the Color Trails Test	Visit 2 (Up to 2 hours)	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.
Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Digit Span Test	Visit 2 (Up to 2 hours)	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.
Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Letter Number Sequence Test	Visit 2 (Up to 2 hours)	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
Cognitive Function assessed by the Stroop Test	Visit 2 (Up to 2 hours)	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
Cognitive Function assessed by the California Computerized Assessment Package (CALCAP)	Visit 2 (Up to 2 hours)	The California Computerized Assessment Package assesses reaction times, speed of information processing, rapid visual scanning, form discrimination, brief memory and divided attention.
Self-Management assessed by the Self-care Index Heart Failure (SCHFI)	Visit 2 (Up to 2 hours)	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.
Peak oxygen consumption assessed by the Modified Balke Test	Visit 2 (Up to 2 hours)	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.
Quality of Life assessed by the Kansas City Cardiomyopathy Questionnaire	Visit 2 (Up to 2 hours)	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.

Trial Locations

Locations (3)

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

The Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Emory St. Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States