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
This trial does not accept healthy volunteersQualifiers
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 population
All-comers registry of patients with HF with mildly reduced (41-49% - HFmrEF) and reduced left ventricle ejection fraction (≤40% - HFrEF)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Echocardiography
Diagnostic testTransthoracic echocardiography with standard measurements
Doppler sonography
Diagnostic testTranscarotid and transcranial Doppler sonography
Neuropsychological tests
Diagnostic testMini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Isolated HF Group3 interventions
Group B: HF + CS group3 interventions
Group C: Control group3 interventions
Trial outcomes
Primary outcomes
1
Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction (MMSE)
Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction according to Mini Mental State Examination (MMSE score ≥10)
Time frame
At six months from HF diagnosisSecondary outcomes
1
Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction (MoCA)
Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score ≥10)
Time frame
At six months from HF diagnosis2
Proportion of patients with mild cognitive dysfunction (MMSE)
Proportion of patients with mild cognitive dysfunction according to Mini Mental State Examination (MMSE score 20 - 25)
Time frame
At six months from HF diagnosis3
Proportion of patients with mild cognitive dysfunction (MoCA)
Proportion of patients with mild cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score 18 - 25)
Time frame
At six months from HF diagnosis4
Proportion of patients with moderate cognitive dysfunction (MMSE)
Proportion of patients with moderate cognitive dysfunction according to Mini Mental State Examination (MMSE score 10 - 19)4. Proportion of patients with moderate cognitive dysfunction according to Mini Mental State Examination (MMSE score 10 - 19)
Time frame
At six months from HF diagnosisSponsors and contacts
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Source ClinicalTrials.gov