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The HF-POL Study - Multicenter Study of Polish Patients With HF and LVEF >40%

The HF-POL Study - Multicenter Study of Polish Patients With Heart Failure and Left Ventricular Ejection Fraction >40%

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06030661
Acronym
HF-POL
Enrollment
1497
Registered
2023-09-11
Start date
2022-01-07
Completion date
2025-09-01
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure with preserved ejection fraction, heart failure with mildly reduced ejection fraction

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.

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.

Interventions

None listed

Sponsors

Medical University of Silesia
CollaboratorOTHER
University of Opole
CollaboratorOTHER
Medical University of Warsaw
CollaboratorOTHER
Wroclaw Medical University
CollaboratorOTHER
Military Institute od Medicine National Research Institute
CollaboratorOTHER
Jagiellonian University
CollaboratorOTHER
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
CollaboratorOTHER
Medical University of Bialystok
CollaboratorOTHER
Świętokrzyskie Cardiology Center of Kielce
CollaboratorUNKNOWN
Regional Specialist Hospital in Rybnik
CollaboratorUNKNOWN
Medical University of Lodz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* 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

Exclusion criteria

* age \<18 years * dyspnea due to other causes than Heart Failure.

Design outcomes

Primary

MeasureTime frameDescription
Death andr/or the first heart failure hospitalisationFrom randomisation to end-of-study ( 3 years)Occurrence of all-cause mortality and/or the first heart failure hospitalisation

Secondary

MeasureTime frameDescription
All heart failure hospitalisationsFrom randomisation to end-of-study (3 years)Number of heart failure hospitalisations
All cause hospitalisationsFrom randomisation to end-of-study ( 3 years)Number of all cause hospitalisation

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026