Clinical trial NCT06030661: The HF-POL Study - Multicenter Study of Polish Patients With HF and LVEF >40%
Official title: The HF-POL Study - Multicenter Study of Polish Patients With Heart Failure and Left Ventricular Ejection Fraction >40%
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure
Keywords: heart failure with preserved ejection fraction
heart failure with mildly reduced ejection fraction
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
Collaborators: name: Medical University of Silesia
name: University of Opole
name: Medical University of Warsaw
name: Wroclaw Medical University
name: Military Institute od Medicine National Research Institute
name: Jagiellonian University
name: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
name: Medical University of Bialystok
name: Świętokrzyskie Cardiology Center of Kielce
name: Regional Specialist Hospital in Rybnik
First posted: 2023-09-11
Enrollment: 1497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Polish population with Heart Failure and EF \>40%.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Death andr/or the first heart failure hospitalisation
timeFrame: From randomisation to end-of-study ( 3 years)
Secondary outcomes:
measure: All heart failure hospitalisations
timeFrame: From randomisation to end-of-study (3 years)
measure: All cause hospitalisations
timeFrame: From randomisation to end-of-study ( 3 years)
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Department of Noninvasive Cardiology, Medical University of Lodz
Study officials:
affiliation: Medical University of Lodz
name: Malgorzata Lelonek, Prof.MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: