TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure

Heart Failure Clinical Trial

— TRACE-IMPAIR  

Official title:

TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Patients With Heart Failure and Presence/Absence of Atherosclerotic Carotid Artery Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250349
• Other study ID #: TRACE-IMPAIR
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2027

Study information

• Verified date: February 2022
• Source: John Paul II Hospital, Krakow
• Contact: Piotr Musialek, MD, DPhil
• Phone: +48126142287
• Email: pmusialek[@]szpitaljp2.krakow.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Stenosis
• Cognitive Dysfunction
• Cognitive Impairment
• Constriction, Pathologic
• Heart Failure

Intervention

Diagnostic Test:
• Echocardiography
Transthoracic echocardiography with standard measurements
• Doppler sonography
Transcarotid and transcranial Doppler sonography
• Neuropsychological tests
Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)

Locations

Country	Name	City	State
Poland	Department of Cardiac and Vascular Diseases, The John Paul II Hospital	Kraków	MP

Sponsors (1)

Lead Sponsor	Collaborator
John Paul II Hospital, Krakow

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At six months from HF diagnosis
Secondary	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)	At six months from HF diagnosis
Secondary	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)	At six months from HF diagnosis
Secondary	Proportion of patients with mild cognitive dysfunction (MoCA)	Proportion of patients with mild cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score 18 - 25)	At six months from HF diagnosis
Secondary	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)	At six months from HF diagnosis
Secondary	Proportion of patients with moderate cognitive dysfunction (MoCA)	Proportion of patients with moderate cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score 10 - 17)	At six months from HF diagnosis
Secondary	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)	At six months from HF diagnosis
Secondary	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)	At six months from HF diagnosis