Lesser Poland Cracovian Heart Failure Registry

Heart Failure Clinical Trial

— LECRA-HF  

Official title:

Lesser Poland Cracovian Heart Failure Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746923
• Other study ID #: 1072.6120.349.2022
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Jagiellonian University
• Contact: Konrad Stepien, MD
• Phone: 12 614 22 18
• Email: konrad.stepien[@]uj.edu.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hospitalization due to acute heart failure

• > 18 years of age

Exclusion Criteria:

• inability to give informed consent to participate in the registry

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Acute

Locations

Country	Name	City	State
Poland	Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow, Jagiellonian University Medical College	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LVEF increase >10% in the follow-up echocardiography	In accordance with HFimpEF definition	2 years
Primary	All-cause mortality	Mortality due to all causes	2 years
Secondary	Cardiovascular mortality	Mortality due to CV causes	2 years
Secondary	HF rehospitalizations	Rehospitalizations related to HF decompensation	2 years