NCT02572648CompletedNot Applicable
A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Structural White Matter
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
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
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Functional Connectivity(Visit 1 (Up to 2 hours))
- Global Cerebral Blood Flow (CBF)(Visit 1 (Up to 2 hours))
- Regional Cerebral Blood Flow (CBF)(Visit 1 (Up to 2 hours))
- Structural Grey Matter(Visit 1 (Up to 2 hours))
- Cognitive Function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(Visit 2 (Up to 2 hours))
- Cognitive Function assessed by the Controlled Oral Word Association (COWA) Test(Visit 2 (Up to 2 hours))
- Cognitive Function assessed by the Color Trails Test(Visit 2 (Up to 2 hours))
- Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Digit Span Test(Visit 2 (Up to 2 hours))
- Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Letter Number Sequence Test(Visit 2 (Up to 2 hours))
- Cognitive Function assessed by the Stroop Test(Visit 2 (Up to 2 hours))
- Cognitive Function assessed by the California Computerized Assessment Package (CALCAP)(Visit 2 (Up to 2 hours))
- Self-Management assessed by the Self-care Index Heart Failure (SCHFI)(Visit 2 (Up to 2 hours))
- Peak oxygen consumption assessed by the Modified Balke Test(Visit 2 (Up to 2 hours))
- Quality of Life assessed by the Kansas City Cardiomyopathy Questionnaire(Visit 2 (Up to 2 hours))
Investigators
Rebecca Gary
Associate Professor
Emory University
Study Sites (3)
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