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Brain Alterations and Cognitive Impairment in Older Adults With Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01821638
First received: March 20, 2013
Last updated: June 21, 2016
Last verified: June 2016
  Purpose
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.

Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Alterations and Cognitive Impairment in Older Adults With Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Mean neuropsychological test scores and brain changes [ Time Frame: One year ] [ Designated as safety issue: No ]

    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


Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Older adults with heart failure
Older adults with heart failure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Older adults with heart failure
Criteria

Inclusion Criteria:

  • 65 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821638

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
Investigators
Principal Investigator: Lisa C Bratzke, PhD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01821638     History of Changes
Other Study ID Numbers: 2012-1064 
Study First Received: March 20, 2013
Last Updated: June 21, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Wisconsin, Madison:
Heart failure
Cognition
Brain
Older adults

Additional relevant MeSH terms:
Heart Failure
Cognition Disorders
Heart Diseases
Cardiovascular Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 26, 2016