Heart FailureHF-POLNCT06030661
The HF-POL Study - Multicenter Study of Polish Patients With HF and LVEF >40%
An observational study of Heart Failure, run by Medical University of Lodz at 1 site in Poland.
Trial summary
HF-POL is the first Polish multicenter observational prospective registry of patients with heart failure and ejection fraction more than 40% designed by Heart Failure Association of the Polish Cardiac Society. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 1,497 participants
- Where
- 1 sitePoland
- Study dates
- 7 Jan 2022to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Polish population with Heart Failure and EF >40%.
Who may be able to join
- age >18 years
- documented EF >40%
- symptomatic chronic Heart Failure or acute Heart Failure (worsening of chronic Heart Failure or Heart Failure de novo) requiring hospitalization and intravenous agents
Who cannot join
- age <18 years
- dyspnea due to other causes than Heart Failure.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Noninvasive Cardiology, Medical University of Lodz
Lodz, 90-549
About this study
Official title: The HF-POL Study - Multicenter Study of Polish Patients With Heart Failure and Left Ventricular Ejection Fraction >40%
HF-POL is the first Polish multicenter observational prospective registry of patients with heart failure and ejection fraction more than 40% designed by Heart Failure Association of the Polish Cardiac Society. The purpose of this study was to provide first characteristics of Polish population patients with heart failure and EF>40% and to provide a better understanding of medical practice, based on observational data, including diagnosis, treatment, and prognosis over 3-year follow-up.
Read the detailed description
HF-POL is the first Polish multicenter observational prospective registry of patients with heart failure and ejection fraction more than 40%. HF-POL study is conducted by the Heart Failure Association of the Polish Cardiac Society in cooperation with the Committee for Clinical Initiatives of the Executive Board as part of the Scientific Platform initiative. The leading center of the study is the Military Medical Academy Memorial Teaching Hospital of the Medical University of Lodz, Poland. The Primary Investigator is Malgorzata Lelonek; the Steering Committee includes Malgorzata Lelonek, Mariusz Gasior, and Marcin Grabowski. The study was approved by the Bioethics Committee at the Medical University of Lodz (No. RNN/240/21/KE; October 21, 2021).
The purpose of this study was to provide first characteristics of Polish population patients with heart failure and EF>40% and to provide a better understanding of medical practice, based on observational data, including diagnosis, treatment, and prognosis over 3-year follow-up. Patients have been recruited at each participating center since that center's activation on the eCRF.biz platform (a clinical data management system, https://rejestr.gbbsoft.pl/hf-pol). We collected data included demographics, medical history, concomitant medications, selected laboratory, electrocardiographic and echocardiographic results as well ascomorbidities. Patients are diagnosed and treated according to the current clinical practice guidelines and the standard of care at participating centers.
All consecutive patients meeting the inclusion and exclusion criteria are being enrolled.
Heart Failure should be recognized according to the 2021 ESC guidelines. The study allows recruitment based on results from medical records, especially for outpatients with a history of Heart Failure. The study population includes patients with Heart Failure and LVEF >40%. In total, a minimum of 1000 patients from 14 Polish centers will be enrolled.
Patients will stay in 3-year follow-up.
- Conditions
- Heart Failure
- Keywords
- heart failure with preserved ejection fraction, heart failure with mildly reduced ejection fraction
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Death andr/or the first heart failure hospitalisation
Occurrence of all-cause mortality and/or the first heart failure hospitalisation
Measured: From randomisation to end-of-study ( 3 years)
Secondary outcomes (2)
All heart failure hospitalisations
Number of heart failure hospitalisations
Measured: From randomisation to end-of-study (3 years)
All cause hospitalisations
Number of all cause hospitalisation
Measured: From randomisation to end-of-study ( 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start7 Jan 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (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
- 1,497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Silesia, University of Opole, Medical University of Warsaw, Wroclaw Medical University, Military Institute od Medicine National Research Institute, Jagiellonian University, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland, Medical University of Bialystok, Świętokrzyskie Cardiology Center of Kielce, Regional Specialist Hospital in Rybnik
- Responsible party
- Sponsor
- Investigators
- Malgorzata Lelonek, Prof.MD, PhD, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030661
- Sponsor's protocol ID
- RNN/240/21/KE
- Acronym
- HF-POL
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HF-POL Study - Multicenter Study of Polish Patients With Heart Failure and Left Ventricular Ejection Fraction >40%
- ClinicalTrials.gov ID
- NCT06030661
- Acronym / sponsor ID
- HF-POL / RNN/240/21/KE
- Conditions
- Heart Failure
- Keywords
- heart failure with preserved ejection fraction, heart failure with mildly reduced ejection fraction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,497 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- Medical University of Silesia, University of Opole, Medical University of Warsaw, Wroclaw Medical University, Military Institute od Medicine National Research Institute, Jagiellonian University, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland, Medical University of Bialystok, Świętokrzyskie Cardiology Center of Kielce, Regional Specialist Hospital in Rybnik
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 11 Sep 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.
HF-POL is the first Polish multicenter observational prospective registry of patients with heart failure and ejection fraction more than 40% designed by Heart Failure Association of the Polish Cardiac Society. The purpose of this study was to provide first characteristics of Polish population patients with heart failure and EF>40% and to provide a better understanding of medical practice, based on observational data, including diagnosis, treatment, and prognosis over 3-year follow-up.
Detailed description
HF-POL is the first Polish multicenter observational prospective registry of patients with heart failure and ejection fraction more than 40%. HF-POL study is conducted by the Heart Failure Association of the Polish Cardiac Society in cooperation with the Committee for Clinical Initiatives of the Executive Board as part of the Scientific Platform initiative. The leading center of the study is the Military Medical Academy Memorial Teaching Hospital of the Medical University of Lodz, Poland. The Primary Investigator is Malgorzata Lelonek; the Steering Committee includes Malgorzata Lelonek, Mariusz Gasior, and Marcin Grabowski. The study was approved by the Bioethics Committee at the Medical University of Lodz (No. RNN/240/21/KE; October 21, 2021).
The purpose of this study was to provide first characteristics of Polish population patients with heart failure and EF>40% and to provide a better understanding of medical practice, based on observational data, including diagnosis, treatment, and prognosis over 3-year follow-up. Patients have been recruited at each participating center since that center's activation on the eCRF.biz platform (a clinical data management system, https://rejestr.gbbsoft.pl/hf-pol). We collected data included demographics, medical history, concomitant medications, selected laboratory, electrocardiographic and echocardiographic results as well ascomorbidities. Patients are diagnosed and treated according to the current clinical practice guidelines and the standard of care at participating centers.
All consecutive patients meeting the inclusion and exclusion criteria are being enrolled.
Heart Failure should be recognized according to the 2021 ESC guidelines. The study allows recruitment based on results from medical records, especially for outpatients with a history of Heart Failure. The study population includes patients with Heart Failure and LVEF >40%. In total, a minimum of 1000 patients from 14 Polish centers will be enrolled.
Patients will stay in 3-year follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Polish population with Heart Failure and EF >40%.
Key inclusion criteria (3 listed)
- age >18 years
- documented EF >40%
- symptomatic chronic Heart Failure or acute Heart Failure (worsening of chronic Heart Failure or Heart Failure de novo) requiring hospitalization and intravenous agents
Key exclusion criteria (2 listed)
- age <18 years
- dyspnea due to other causes than Heart Failure.
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
Death andr/or the first heart failure hospitalisation
Time frame: From randomisation to end-of-study ( 3 years)
Occurrence of all-cause mortality and/or the first heart failure hospitalisation
2 secondary outcomes
All heart failure hospitalisations
Time frame: From randomisation to end-of-study (3 years)
All cause hospitalisations
Time frame: From randomisation to end-of-study ( 3 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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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. This study is not recruiting at the moment.
Malgorzata Lelonek, Prof.MD, PhD principal investigator
Medical University of Lodz
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, run by Medical University of Lodz 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death andr/or the first heart failure hospitalisation (time frame: From randomisation to end-of-study ( 3 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 11 Sep 2023.