Clinical trial NCT05746923: Lesser Poland Cracovian Heart Failure Registry
Official title: Lesser Poland Cracovian Heart Failure Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Heart Failure Acute
Keywords: heart failure
acute heart failure
decompensation
revascularization
long-term prognosis
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of hospitalized patients with acute heart failure who are over 18 years of age, both women and men. Patients will be initially categorized into one of three groups based on the current European Society of Cardiology (ESC) heart failure guidelines based on left ventricular ejection fraction (LVEF) values: patients with reduced (LVEF ≤40%), mildly reduced (LVEF 41-49%) and preserved (LVEF ≥50%) ejection fraction.

Brief summary: The goal of Lesser Poland Cracovian Heart Failure Registry (LECRA-HF) is to expand the knowledge about acute heart failure (AHF) and its long-term prognosis.

The main questions are:

* assessment of long-term prognosis of AHF and its determinants
* determination of the optimal AHF treatment methods
* assessment of indications for invasive coronary arteries diagnostics and revascularization and their long-term effects
* analysis of the particular HF subtypes (HFimpEF, HFpEF, HFsnEF, HFrEF, HFmrEF)

Detailed description: LECRA-HF is a registry of patients with acute heart failure (AHF) hospitalized in the Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow, Jagiellonian University Medical College. So far, a small population of patients has been included in similar registries conducted in the Polish population. This did not allow to draw reliable conclusions about this diverse group of patients.

As part of the LECRA-HF registry, a comprehensive analysis of the clinical characteristics of patients is planned, taking into account their medical history, anthropometric measurements, results of electrocardiographic, imaging and laboratory tests, as well as the treatment used during the index hospitalization and after discharge. Their long-term prognosis will also be analyzed. LECRA-HF is a continuous registry, updated annually until 2026.

The data collected in the LECRA-HF will be used to distinguish and describe relatively new subtypes of HF (HFimpEF, HFsnEF) as well as to properly characterize that difficult and very diverse population with a serious long-term prognosis.

Eligibility criteria: Inclusion Criteria:

* hospitalization due to acute heart failure
* \> 18 years of age

Exclusion Criteria:

* inability to give informed consent to participate in the registry

Primary outcomes:
measure: All-cause mortality
timeFrame: 2 years
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 2 years
measure: HF rehospitalizations
timeFrame: 2 years
Other outcomes:
measure: LVEF increase >10% in the follow-up echocardiography
timeFrame: 2 years
Locations:
city: Kraków
country: Poland
facility: Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow, Jagiellonian University Medical College
Study officials:
affiliation: Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow
name: Jadwiga Nessler, Prof.
role: STUDY_CHAIR
affiliation: Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow
name: Konrad Stępień, MD
role: PRINCIPAL_INVESTIGATOR
References: