NCT05746923

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Feb 2023Dec 2026

Study Start

First participant enrolled

February 15, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

February 17, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

heart failureacute heart failuredecompensationrevascularizationlong-term prognosis

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Mortality due to all causes

    2 years

Secondary Outcomes (2)

  • Cardiovascular mortality

    2 years

  • HF rehospitalizations

    2 years

Other Outcomes (1)

  • LVEF increase >10% in the follow-up echocardiography

    2 years

Study Arms (1)

LECRA-HF patients

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.

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • inability to give informed consent to participate in the registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow, Jagiellonian University Medical College

Krakow, 31-202, Poland

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jadwiga Nessler, Prof.

    Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow

    STUDY CHAIR
  • Konrad Stępień, MD

    Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 28, 2023

Study Start

February 15, 2023

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations