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Status unknownNCT06030661HF-POLUpdated Sep 11, 2023

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

An observational study in Heart Failure, sponsored by Medical University of Lodz. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-11.

Sponsored by Medical University of Lodz · Observational

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,497
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • heart failure with preserved ejection fraction
  • heart failure with mildly reduced ejection fraction
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In context

Heart Failure

5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's enrollment of 1,497 is above the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Medical University of Lodz is the lead sponsor of 104 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Polish population with Heart Failure and EF >40%.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,497 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Death andr/or the first heart failure hospitalisation

    Occurrence of all-cause mortality and/or the first heart failure hospitalisation

    Time frame: From randomisation to end-of-study ( 3 years)

Secondary outcomes

  1. All heart failure hospitalisations

    Number of heart failure hospitalisations

    Time frame: From randomisation to end-of-study (3 years)

  2. All cause hospitalisations

    Number of all cause hospitalisation

    Time frame: From randomisation to end-of-study ( 3 years)

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Study locations

1 site
  • Department of Noninvasive Cardiology, Medical University of Lodz
    Lodz, 90-549, Poland
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2022 (actual). Primary completion is estimated for Aug 2025, 42 months after the start.

Of 665 non-industry observational studies under Heart Failure, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 89. This study's planned 42 months is close to that.

Counting every sponsor, half of 825 studies reached it within 40 months; a quarter within 21 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2023
First posted
Sep 11, 2023
StartActual
Jan 7, 2022
Primary completionEst.
Aug 1, 2025
CompletionEst.
Sep 1, 2025
Last update
Sep 11, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06030661
Collaborators
Medical University of Silesia, University of Opole, Medical University of Warsaw, Wroclaw Medical University, Military Institute od Medicine National Research Institute, Jagiellonian University, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland, Medical University of Bialystok, Świętokrzyskie Cardiology Center of Kielce, Regional Specialist Hospital in Rybnik
Responsible party
Sponsor
First posted
Sep 11, 2023
Start date
Jan 7, 2022
Primary completion
Aug 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Sep 11, 2023

Study contacts

Malgorzata Lelonek, Prof.MD, PhD
principal investigator · Medical University of Lodz

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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