Exploring Brain Changes in Patients with Heart Failure with Reduced Ejection Fraction During Vulnerable Period.
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0007355
- Lead Sponsor
- Koera University Guro Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
1. Patient with left ventricular ejection fraction of 40% or less on echocardiogram within 3 months.
2. Patient with sinus rhythm without atrial fibrillation.
3. Patient who have experienced worsening heart failure within 4 weeks or have been newly diagnosed with heart failure.
1) Symptoms above NYHA II
2) NT-proBNP 800 = pg/mL
4. Patient who can take a brain MRI without assistance.
1. Patient who has been diagnosed with atrial fibrillation or is being treated.
2. Patient who had a stroke or cerebral hemorrhage within 3 months of participation in the study.
3. Patient who has a myocardial infarction or needs surgery or vascular intervention for coronary artery disease at the time of participation in the study.
4. Patient who are taking more than one anti-platelet drug at the time of participation in the study. (COX-1 inhibitor such as aspirin, triflusal, ADP receptor antagonists such as clopidogrel, ticlopidine, prasugrel, ticagrelor. PDE-3 inhibitor such as cilostazol, dipyridamole. serotonin receptor antagonists such as sarpogrelate.)
5. Patient who are taking anticoagulation drug or need anticoagulation (e.g. mechanical valves, moderate to severe mitral stenosis, pulmonary thromboembolism or deep vein thrombosis.)
6. Patient with terminal heart failure expected to die within 6 months
7. Patient who is a bed-ridden state or cannot take a brain MRI without help.
8. Patient who have already been diagnosed with dementia and are taking drugs such as donepezil, galantamine and rivastigmine.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cortical thickness;the number of cortical microinfarcts;number of lacunes;white matter hyperintensity severity;the number of microbleeds
- Secondary Outcome Measures
Name Time Method Mini-Mental State Examination, MMSE;Seoul Verbal learning Test;Digit Span Test;Stroop-CR;Phonemic Controlled Oral Word Association Test;Trail Making Test-B, TMT-B;Digit Symbol Coding, DSC;Korea version of Boston Naming Test, K-BNT;Semantic Controlled Oral Word Association Test;Rey–Osterrieth Complex Figure Copy Test