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

Emory University

Status: Completed

Conditions: Heart Failure

Treatments: Other: Cognitive Function Assessment; Other: Brain Imaging (Neuroimaging)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02572648

IRB00083607

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

Participants with Heart Failure

Description:

Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).

Treatment:

Other: Cognitive Function Assessment

Other: Brain Imaging (Neuroimaging)

Healthy Controls

Description:

Healthy controls will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).

Treatment:

Other: Cognitive Function Assessment

Other: Brain Imaging (Neuroimaging)