TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure (TRACE-IMPAIR)

John Paul II Hospital, Krakow

Status: Enrolling

Conditions: Cognitive Impairment; Carotid Stenosis; Heart Failure

Treatments: Diagnostic Test: Doppler sonography; Diagnostic Test: Neuropsychological tests; Diagnostic Test: Echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT05250349

TRACE-IMPAIR

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

Isolated HF Group

Description:

Patients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) and clinical symptoms (NYHA I-III).

Treatment:

Diagnostic Test: Doppler sonography

Diagnostic Test: Neuropsychological tests

Diagnostic Test: Echocardiography

HF + CS group

Description:

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.

Treatment:

Diagnostic Test: Doppler sonography

Diagnostic Test: Neuropsychological tests

Diagnostic Test: Echocardiography

Control group

Description:

A cohort of patients without Heart Failure or other significant cardiac pathology and without Carotid Stenosis (a paired propensity match will be performed).

Treatment:

Diagnostic Test: Doppler sonography

Diagnostic Test: Neuropsychological tests

Diagnostic Test: Echocardiography