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

NCT ID: NCT06030661

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1497 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2025-09-01

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Silesia

OTHER

Sponsor Role: collaborator

University of Opole

OTHER

Sponsor Role: collaborator

Medical University of Warsaw

OTHER

Sponsor Role: collaborator

Wroclaw Medical University

OTHER

Sponsor Role: collaborator

Military Institute od Medicine National Research Institute

OTHER

Sponsor Role: collaborator

Jagiellonian University

OTHER

Sponsor Role: collaborator

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

OTHER

Sponsor Role: collaborator

Medical University of Bialystok

OTHER

Sponsor Role: collaborator

Świętokrzyskie Cardiology Center of Kielce

UNKNOWN

Sponsor Role: collaborator

Regional Specialist Hospital in Rybnik

UNKNOWN

Sponsor Role: collaborator

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malgorzata Lelonek, Prof.MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lodz

Locations

Department of Noninvasive Cardiology, Medical University of Lodz

Lodz, , Poland

Countries

Poland

Other Identifiers

RNN/240/21/KE

Identifier Type: -

Identifier Source: org_study_id