Clinical trial NCT05250349: TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure
Official title: TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Patients With Heart Failure and Presence/Absence of Atherosclerotic Carotid Artery Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Cognitive Impairment
Carotid Stenosis
Keywords: Carotid Stenosis
Heart Failure
Carotid Doppler
Transcranial Doppler
Cerebral Flow
Cognitive Impairment
Stroke Volume
Lead sponsor: John Paul II Hospital, Krakow
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers registry of patients with HF with mildly reduced (41-49% - HFmrEF) and reduced left ventricle ejection fraction (≤40% - HFrEF)

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 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.

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. 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).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction (MMSE)
timeFrame: At six months from HF diagnosis
Secondary outcomes:
measure: Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction (MoCA)
timeFrame: At six months from HF diagnosis
measure: Proportion of patients with mild cognitive dysfunction (MMSE)
timeFrame: At six months from HF diagnosis
measure: Proportion of patients with mild cognitive dysfunction (MoCA)
timeFrame: At six months from HF diagnosis
measure: Proportion of patients with moderate cognitive dysfunction (MMSE)
timeFrame: At six months from HF diagnosis
measure: Proportion of patients with moderate cognitive dysfunction (MoCA)
timeFrame: At six months from HF diagnosis
measure: Proportion of patients with moderate reduced cerebral flow velocity
timeFrame: At six months from HF diagnosis
measure: Proportion of patients with significantly reduced cerebral flow velocity
timeFrame: At six months from HF diagnosis
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Department of Cardiac and Vascular Diseases, The John Paul II Hospital
state: MP
Study officials:
affiliation: John Paul II Hospital
name: Piotr Musialek, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References: