Brain and Cognition Effects of Cardio Resynchronization Therapy in Heart Failure
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 17-010930
Sponsor Protocol Number: 17-010930
About this study
The purpose of this research study is to understand the effects of changes in the capability of the heart on brain function so that we can better predict who will most benefit from cardio-resynchronization therapy (CRT) and how it may enhance brain health.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Men and women
- Age: 40-80 yrs
- English speaking
- Physically mobile (enough to get an MRI).
Exclusion Criteria
- Prior significant neurological disorder (e.g., dementia, seizure disorder, moderate or severe traumatic brain injury)
- We will exclude participants from analysis and further enrollment (follow-up visits) who reveal dementia based on NINDS-AIREN criteria
- Major psychiatric disturbance (e.g., schizophrenia, chronic intractable depression, substance abuse)
- Evidence of major ischemic or hemorrhagic stroke
- Other unstable medical conditions (e.g. cancer; basal cell skin and limited prostate cancer are acceptable)
- MRI contraindications (e.g., pregnancy, claustrophobia, metal implants, circumference > 60 inches, weight > 425 lbs)
- Physical impairment precluding motor response or lying still for 1 hr.
- Use of medications known to influence cognitive functions (e.g., benzodiazepines, barbiturates, antipsychotics)
- Cardiac pacemaker dependence
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Erik Middlebrooks, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available