Brain Alterations and Cognitive Impairment in Older Adults With Heart Failure

NCT01821638 | Completed

• 1 other identifier: 2012-1064
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive impairment, commonly reported as difficulty with memory and executive function, is a widely recognized clinical challenge for older persons with heart failure (HF). Little is known about the relationship between brain MRI and cognitive impairment in older persons with HF. A limited number of studies have investigated brain MRI in adults with HF and produced conflicting results. Previous findings are limited by use of lower resolution scanners (1.5 Tesla), lack of MRI techniques (i.e. combining structural sequences with perfusion sequences) and recruitment of mixed age samples. Based on these limitations, the purpose of this research plan is to explore the relationship between brain MRI and cognitive impairment in older persons with HF using high resolution structural and perfusion scans. To accomplish this goal, investigators will compare 40 adults with HF who are age \> 65 years old with 40 healthy, gender, age, and education matched controls. Investigators will obtain neuropsychological measures of multiple domains, as well as MRI measurements of the temporal lobe and prefrontal cortex at baseline and 12-months.

Conditions

Heart Failure

Keywords

Heart failure; Cognition; Brain; Older adults

Outcome Measures

Primary Outcomes (1)

• Mean neuropsychological test scores and brain changes

  Compare mean values of the following outcomes between older adults with heart failure and older adults without heart failure at baseline * neuropsychological test scores * brain medial temporal lobe volume * brain frontal cortex volume * brain medial temporal lobe perfusion * brain frontal cortex perfusion Compare mean value changes in the following outcomes between baseline and one year in patients with heart failure: * neuropsychological test scores * brain medial temporal lobe volume * brain frontal cortex volume * brain medial temporal lobe perfusion * brain frontal cortex perfusion

  One year

Study Arms (1)

Older adults with heart failure

Older adults with heart failure

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults with heart failure

You may qualify if:

• years old or older
• English speaking and writing;
• Stable guideline based medication regimen for at least four weeks prior to enrollment
• New York Heart Association classification I-IV

You may not qualify if:

• Mini-Mental Status Exam score equal to or less than 24;
• Current diagnosis of neurological illnesses or movement disorders (e.g. Alzheimer's dementia, Parkinson's disease, Epilepsy);
• History of substance abuse/treatment;
• Untreated depression
• History of stroke;
• Hepatic insufficiency;
• Severe renal failure;
• Untreated anemia;
• Left ventricular assist device;
• History of the following within three months of study enrollment: acute myocardial infarction, unstable angina, coronary artery bypass surgery, percutaneous transluminal angioplasty, or biventricular pacemaker insertion;
• History of implantable device (or other MRI contraindications).
• Prisoners
• Pregnancy

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Lisa C Bratzke, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: April 1, 2013
• Study Start: April 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)