Status:
RECRUITING
TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure
Lead Sponsor:
John Paul II Hospital, Krakow
Conditions:
Heart Failure
Cognitive Impairment
Eligibility:
All Genders
18+ years
Brief Summary
TRACE-IMPAIR is a prospective, clinical study of consecutive patients that evaluates the relationship between heart failure (HF) and cognitive impairment in relation to carotid and cerebral flow. The ...
Detailed Description
Circumstantial evidence suggests that cognitive dysfunction may occur in HF patients as often undiagnosed comorbidity. Cognitive dysfunction may aggravate HF symptoms and influence prognosis. Cognitiv...
Eligibility Criteria
Inclusion
- Clinically stable patients (NYHA I-III symptoms) with HF (for at least 6 months) either of ischemic or inflammatory etiology as well as genetic cardiomyopathies
- Signed informed consent form
- Consent to imaging studies: echocardiography, carotid and transcranial Doppler sonography and neuropsychological tests (MMSE and MoCA).
Exclusion
- Co-existing, severe, irreversible disease (e.g. advanced cancer)
- Previously diagnosed dementia (including severe dementia - MMSE and MoCA score \<10)
- Psychiatric condition which may influence cognitive function
- Acute, decompensated HF
- Reversible cause of HF - tachyarrhytmic, peripartum or toxic cardiomyopathy, acute myocarditis, acute myocardial infarction
- Aortic stenosis
- Cerebral stroke in the preceding 3 months
- Lack of transcranial Doppler acoustic window
- Echocardiographic projections precluding adequate measurements
- Anemia with Hemoglobin \< 8 g/dl
- Alcohol or psychoactive agents abuse
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05250349
Start Date
September 1 2021
End Date
September 1 2027
Last Update
February 22 2022
Active Locations (1)
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1
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
Krakow, MP, Poland, 31-202