Evaluating the link between heart failure and cognitive impairment using Doppler imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.