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

Heart Failure Clinical Trial

— HF-POL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06030661
• Other study ID #: RNN/240/21/KE
• Status: Active, not recruiting
• Start date: January 7, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2023
• Source: Medical University of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1497
• Est. completion date: September 1, 2025
• Est. primary completion date: August 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Poland	Department of Noninvasive Cardiology, Medical University of Lodz	Lódz

Sponsors (11)

Lead Sponsor

Collaborator

Medical University of Lodz

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

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death andr/or the first heart failure hospitalisation	Occurrence of all-cause mortality and/or the first heart failure hospitalisation	From randomisation to end-of-study ( 3 years)
Secondary	All heart failure hospitalisations	Number of heart failure hospitalisations	From randomisation to end-of-study (3 years)
Secondary	All cause hospitalisations	Number of all cause hospitalisation	From randomisation to end-of-study ( 3 years)