Clinical trial NCT02572648: A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls
Official title: A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Cardiomyopathy
Magnetic Resonance Imaging (MRI)
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2015-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women with heart failure and men and women without heart failure to serve as healthy age-matched controls.

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.

Eligibility criteria: 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
* 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.

Primary outcomes:
measure: Structural White Matter
timeFrame: Visit 1 (Up to 2 hours)
Secondary outcomes:
measure: Functional Connectivity
timeFrame: Visit 1 (Up to 2 hours)
measure: Global Cerebral Blood Flow (CBF)
timeFrame: Visit 1 (Up to 2 hours)
measure: Regional Cerebral Blood Flow (CBF)
timeFrame: Visit 1 (Up to 2 hours)
measure: Structural Grey Matter
timeFrame: Visit 1 (Up to 2 hours)
measure: Cognitive Function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Visit 2 (Up to 2 hours)
measure: Cognitive Function assessed by the Controlled Oral Word Association (COWA) Test
timeFrame: Visit 2 (Up to 2 hours)
measure: Cognitive Function assessed by the Color Trails Test
timeFrame: Visit 2 (Up to 2 hours)
measure: Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Digit Span Test
timeFrame: Visit 2 (Up to 2 hours)
measure: Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Letter Number Sequence Test
timeFrame: Visit 2 (Up to 2 hours)
measure: Cognitive Function assessed by the Stroop Test
timeFrame: Visit 2 (Up to 2 hours)
measure: Cognitive Function assessed by the California Computerized Assessment Package (CALCAP)
timeFrame: Visit 2 (Up to 2 hours)
measure: Self-Management assessed by the Self-care Index Heart Failure (SCHFI)
timeFrame: Visit 2 (Up to 2 hours)
measure: Peak oxygen consumption assessed by the Modified Balke Test
timeFrame: Visit 2 (Up to 2 hours)
measure: Quality of Life assessed by the Kansas City Cardiomyopathy Questionnaire
timeFrame: Visit 2 (Up to 2 hours)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory St. Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Rebecca Gary
role: PRINCIPAL_INVESTIGATOR
References: