Heart FailureLECRA-HFNCT05746923
Lesser Poland Cracovian Heart Failure Registry
An observational study of Heart Failure and Heart Failure Acute, run by Jagiellonian University at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure Acute
- How many people
- 2,500 participants
- Where
- 1 sitePoland
- Study dates
- 15 Feb 2023to 31 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- hospitalization due to acute heart failure
- > 18 years of age
Who cannot join
- inability to give informed consent to participate in the registry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow, Jagiellonian University Medical College
Krakow, 31-202
Konrad Stępień, MD, 12 614 22 18 ext. +48, konrad.stepien@uj.edu.pl
Karol Nowak, MD, 12 614 22 18 ext. +48, karol.nowak@student.uj.edu.pl
About this study
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)
Read the 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.
- Conditions
- Heart Failure, Heart Failure Acute
- Keywords
- heart failure, acute heart failure, decompensation, revascularization, long-term prognosis
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Mortality due to all causes
Measured: 2 years
Secondary outcomes (2)
Cardiovascular mortality
Mortality due to CV causes
Measured: 2 years
HF rehospitalizations
Rehospitalizations related to HF decompensation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start15 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konrad Stępień, Jagiellonian University
- Investigators
- Jadwiga Nessler, Prof., Study chair, Department of Coronary Disease and Heart Failure, John Paul II Hospital in KrakowKonrad Stępień, MD, Principal investigator, Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746923
- Sponsor's protocol ID
- 1072.6120.349.2022
- Acronym
- LECRA-HF
- Status last verified
- Mar 2024
- First submitted
- 17 Feb 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesser Poland Cracovian Heart Failure Registry
- ClinicalTrials.gov ID
- NCT05746923
- Acronym / sponsor ID
- LECRA-HF / 1072.6120.349.2022
- Conditions
- Heart Failure, Heart Failure Acute
- Keywords
- heart failure, acute heart failure, decompensation, revascularization, long-term prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- hospitalization due to acute heart failure
- > 18 years of age
Key exclusion criteria (1 listed)
- inability to give informed consent to participate in the registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: 2 years
Mortality due to all causes
2 secondary outcomes
Cardiovascular mortality
Time frame: 2 years
HF rehospitalizations
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jadwiga Nessler, Prof. study chair
Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow
Konrad Stępień, MD principal investigator
Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Failure Acute, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Konrad Stępień, MD (12 614 22 18 ext. +48, konrad.stepien@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.