Evaluating the link between heart failure and cognitive impairment using Doppler imaging
TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Patients With Heart Failure and Presence/Absence of Atherosclerotic Carotid Artery Stenosis
This study is trying to see if heart failure affects thinking and memory in younger patients by looking at blood flow in the brain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | John Paul II Hospital, Krakow Academic / other |
| Locations | 1 site (Krakow, MP) |
| Trial ID | NCT05250349 on ClinicalTrials.gov |
What this trial studies
TRACE-IMPAIR is a prospective observational study that investigates the relationship between heart failure (HF) and cognitive impairment by assessing carotid and cerebral blood flow using Doppler ultrasonography. The study includes clinically stable patients with HF and employs neuropsychological tests to evaluate cognitive function. By focusing on both mildly reduced and reduced ejection fraction patients, the study aims to clarify the role of cerebral flow impairment in cognitive dysfunction, particularly in younger patients under 60 years old. This single-center study is conducted at the John Paul II Hospital in Krakow.
Who should consider this trial
Good fit: Ideal candidates are clinically stable heart failure patients with mildly reduced or reduced ejection fraction.
Not a fit: Patients with severe irreversible diseases, previously diagnosed dementia, or acute decompensated heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of cognitive dysfunction in heart failure patients, potentially leading to improved management strategies.
How similar studies have performed: While previous studies have explored similar themes, they often involved small patient groups and varied methodologies, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Krakow, MP
- Department of Cardiac and Vascular Diseases, The John Paul II Hospital — Krakow, Mp, Poland (Recruiting)
Study contacts
- Principal investigator: Piotr Musialek, MD, DPhil — John Paul II Hospital
- Study coordinator: Piotr Musialek, MD, DPhil
- Email: pmusialek@szpitaljp2.krakow.pl
- Phone: +48126142287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.