The HF-POL Study - Multicenter Study of Polish Patients With HF and LVEF >40%
Study Details
Study Description
Brief 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. 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.
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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
Outcome Measures
Primary Outcome Measures
- Death andr/or the first heart failure hospitalisation [From randomisation to end-of-study ( 3 years)]
Occurrence of all-cause mortality and/or the first heart failure hospitalisation
Secondary Outcome Measures
- All heart failure hospitalisations [From randomisation to end-of-study (3 years)]
Number of heart failure hospitalisations
- All cause hospitalisations [From randomisation to end-of-study ( 3 years)]
Number of all cause hospitalisation
Eligibility Criteria
Criteria
Inclusion Criteria:
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age >18 years
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documented EF >40%
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symptomatic chronic Heart Failure or acute Heart Failure (worsening of chronic Heart Failure or Heart Failure de novo) requiring hospitalization and intravenous agents
Exclusion Criteria:
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age <18 years
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dyspnea due to other causes than Heart Failure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | Department of Noninvasive Cardiology, Medical University of Lodz | Łódź | Poland | 90-549 |
Sponsors and Collaborators
- Medical University of Lodz
- 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
Investigators
- Principal Investigator: Malgorzata Lelonek, Prof.MD, PhD, Medical University of Lodz
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RNN/240/21/KE