A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)

Emory University3 sites in 1 country30 target enrollmentOctober 2015

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Emory University
Enrollment: 30
Locations: 3
Primary Endpoint: Structural White Matter
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

August 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Emory University

Responsible Party

Principal Investigator

Rebecca Gary

Associate Professor

Emory University

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

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))