TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohn Paul II Hospital, Krakow
About this trial
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 carotid and cerebral flow will be assessed using Doppler ultrasonography, and cognitive function will be estimated during routine neuropsychological tests.
It is an observational, three(natural)-group, single-center study. It is also an Academic Registry - the scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University, and John Paul II Hospital.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Echocardiography
- Doppler sonography
- Neuropsychological tests
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov