Heart Failure Clinical Trial

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

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.

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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.

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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.

Study is for people with:

Heart Failure

Estimated Enrollment:

30

Study ID:

NCT02572648

Recruitment Status:

Completed

Sponsor:

Emory University

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There are 3 Locations for this study

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Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
The Emory Clinic
Atlanta Georgia, 30322, United States
Emory St. Joseph's Hospital
Atlanta Georgia, 30342, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

30

Study ID:

NCT02572648

Recruitment Status:

Completed

Sponsor:


Emory University

How clear is this clinincal trial information?

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