An observational study in Heart Failure, Cognitive Impairment and Carotid Stenosis, sponsored by John Paul II Hospital, Krakow. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-22.
Sponsored by John Paul II Hospital, Krakow · Observational
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.
Circumstantial evidence suggests that cognitive dysfunction may occur in HF patients as often undiagnosed comorbidity. Cognitive dysfunction may aggravate HF symptoms and influence prognosis. Cognitive dysfunction may be a reason for inadequate self-care and poor symptom control (e.g., weight gain monitoring). In addition, it may affect medication compliance, leading to hospital readmissions and increased mortality. Brain tissue hypoxia, microemboli, silent strokes, and co-existing anemia have been implicated in contributing to cognitive dysfunction in HF. However, the role of cerebral flow impairment in these patients remains unclear. This uncertainty is mainly because previous studies included small patient groups, diverse imaging techniques, and neuropsychological tests. Furthermore, these studies were primarily conducted in the elderly, a potentially important confounder due to the effect of age on cognitive dysfunction. Particularly little data is available for younger patients (\< 60 years).
This study aims to investigate the association of HF, carotid and cerebral flow, and cognitive impairment. Consecutive patients with HF with mildly reduced (HFmrEF) and reduced ejection fraction (HFrEF) will be included in the study. Echocardiography with routine measurements such as ejection fraction and stroke volume will be performed in each patient. The carotid and cerebral flow will be assessed on Doppler ultrasonography. Each patient will undergo cognitive function assessment using Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). The results in the index group (isolated HF) will be compared with those in a group of patients with HF and flow-limiting carotid stenosis (CS) against a control group (no HF, no CS).
All-comers registry of patients with HF with mildly reduced (41-49% - HFmrEF) and reduced left ventricle ejection fraction (≤40% - HFrEF)
Exclusion Criteria:
Patients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) and clinical symptoms (NYHA I-III).
Diagnostic Test: Echocardiography · Diagnostic Test: Doppler sonography · Diagnostic Test: Neuropsychological tests
Patients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) with NYHA I-III symptoms, who were diagnosed with flow limiting Carotid Stenosis on carotid Doppler ultrasound.
Diagnostic Test: Echocardiography · Diagnostic Test: Doppler sonography · Diagnostic Test: Neuropsychological tests
A cohort of patients without Heart Failure or other significant cardiac pathology and without Carotid Stenosis (a paired propensity match will be performed).
Diagnostic Test: Echocardiography · Diagnostic Test: Doppler sonography · Diagnostic Test: Neuropsychological tests
Transthoracic echocardiography with standard measurements
Transcarotid and transcranial Doppler sonography
Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)
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 diagnosis
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 diagnosis
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 diagnosis
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 diagnosis
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 diagnosis
Proportion of patients with moderate cognitive dysfunction (MoCA)
Proportion of patients with moderate cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score 10 - 17)
Time frame: At six months from HF diagnosis
Proportion of patients with moderate reduced cerebral flow velocity
Proportion of patients with reduced cerebral flow velocity (mean cerebral flow velocity \<50 cm/s) in the middle cerebral artery among those with at least moderate (i.e. mild or moderate) cognitive dysfunction according to MMSE (MMSE score ≥10)
Time frame: At six months from HF diagnosis
Proportion of patients with significantly reduced cerebral flow velocity
Proportion of patients with reduced cerebral flow velocity (mean cerebral flow velocity \<50 cm/s) in the middle cerebral artery among those with at least moderate (i.e. mild or moderate) cognitive dysfunction according to MoCA tests (MoCA score≥10)
Time frame: At six months from HF diagnosis
Plan to share: Undecided
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John Paul II Hospital, Krakow