NCT06030661

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,497

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

3.6 years

First QC Date

August 30, 2023

Last Update Submit

September 7, 2023

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • All heart failure hospitalisations

    From randomisation to end-of-study (3 years)

  • All cause hospitalisations

    From randomisation to end-of-study ( 3 years)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Polish population with Heart Failure and EF \>40%.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Noninvasive Cardiology, Medical University of Lodz

Lodz, 90-549, Poland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Malgorzata Lelonek, Prof.MD, PhD

    Medical University of Lodz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 11, 2023

Study Start

January 7, 2022

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

PL(1)