Chronic Thromboembolic Pulmonary HypertensionBNP-PLNCT03959748
DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL
An observational study of Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by Polish Cardiology Association at 1 site in Poland.
Trial summary
The BNP-PL is a multicenter, observational study in which patients are prospectively followed in order to investigate clinical course and management of pulmonary hypertension in Poland. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension
- How many people
- 3,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2018to 28 Feb 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension treated in Polish centres of pulmonary hypertension accredited by the National Health Fund
Who may be able to join
- Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed after 1st March 2018 (incident cases) who:
- are aged > 3 months at the time of enrollment
- fulfill the following hemodinamic criteria: mean pulmonary arterial pressure (mPAP) of 25 mm Hg or more, mean pulmonary arterial wedge pressure (PAWP) or left ventricular end-diastolic pressure (PVEDP) of 15 mm Hg or less, pulmonary vascular resistance (PVR) of 3 Woods.
- Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed before 1st March 2018 (prevalent cases) who:
- are aged > 3 months at the time of enrollment
- fulfill the following hemodinamic criteria: mean pulmonary arterial pressure (mPAP) of 25 mm Hg or more, mean pulmonary arterial wedge pressure (PAWP) or left ventricular end-diastolic pressure (PVEDP) of 15 mm Hg or less, pulmonary vascular resistance (PVR) of 3 Woods
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, 31-202
Grzegorz Kopeć, +48 126143399, grzegorzkrakow1@gmail.com
About this study
The BNP-PL is a multicenter, observational study in which patients are prospectively followed in order to investigate clinical course and management of pulmonary hypertension in Poland.
All patients diagnosed with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension confirmed in right heart catheterization, will be eligible to participate in the study.
Read the detailed description
The BNP-PL Registry is an initiative of the Polish Cardiac Society Task Force for Pulmonary Vascular Diseases This study is conducted by the Polish Cardiac Society. All centers of pulmonary hypertension in Poland which are accredited by the National Health Fund have been invited to join the study. The data is administrated by the Jagiellonian University Medical College on the basis of an agreement between the Polish Cardiac Society, Jagiellonian University Medical College and pulmonary hypertension centres.
The goal is to describe current practice and outcomes in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
The data collection will have no impact on the way the patient is diagnosed and treated.
Collection of data on patients with pulmonary hypertension is carried out via the electronic platform.
No personal data is entered into the project database.
- Keywords
- Pulmonary Hypertension,, CTEPH, Pulmonary Arterial Hypertension, Registry, Data Base, Polish patients
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PAH adults | Patients with pulmonary arterial hypertension who are at least 18 years old at study entry | |
| PAH children | Patients with pulmonary arterial hypertension who are at least 3 months old and are less than 18 years old at study entry | |
| CTEPH | Patients with chronic thromboembolic pulmonary hypertension who are at least 18 years old at study entry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The number of patients who die during the follow-up period
Measured: Since enrollment until at least 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Mar 2018
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Polish Cardiology Association
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University
- Responsible party
- Sponsor
- Investigators
- Grzegorz Kopeć, MD, Phd, Principal investigator, Krakowski Szpital Specjalistyczny im. Jana Pawła II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959748
- Sponsor's protocol ID
- 1/BNP-PL/2018
- Acronym
- BNP-PL
- Status last verified
- May 2019
- First submitted
- 26 Mar 2019
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waligora M, Kurzyna M, Mularek-Kubzdela T, Skoczylas I, Chrzanowski L, Blaszczak P, Jaguszewski M, Kusmierczyk B, Ptaszynska K, Grzesk G, Mizia-Stec K, Malinowska E, Peregud-Pogorzelska M, Lewicka E, Tomaszewski M, Jachec W, Florczyk M, Mroczek E, Gasior Z, Pawlak A, Betkier-Lipinska K, Pruszczyk P, Widejko K, Zablocka W, Kopec G. Effects of beta-Blockers on the Outcomes in Patients With Pulmonary Arterial Hypertension Stratified by the Presence of Comorbid Conditions: A Multicenter Prospective Cohort Study: The Database of Pulmonary Hypertension in the Polish Population (BNP-PL). Chest. 2025 Apr;167(4):1171-1181. doi: 10.1016/j.chest.2024.10.051. Epub 2024 Nov 9.
PubMed 39528108Kopec G, Dzikowska-Diduch O, Mroczek E, Mularek-Kubzdela T, Chrzanowski L, Skoczylas I, Tomaszewski M, Peregud-Pogorzelska M, Karasek D, Lewicka E, Jachec W, Gasior Z, Blaszczak P, Ptaszynska-Kopczynska K, Mizia-Stec K, Biederman A, Zielinski D, Przybylski R, Kedzierski P, Waligora M, Roik M, Grabka M, Orlowska J, Araszkiewicz A, Banaszkiewicz M, Slawek-Szmyt S, Darocha S, Magon W, Dabrowska-Kugacka A, Stepniewski J, Jonas K, Kaminski K, Kasprzak JD, Podolec P, Pruszczyk P, Torbicki A, Kurzyna M. Characteristics and outcomes of patients with chronic thromboembolic pulmonary hypertension in the era of modern therapeutic approaches: data from the Polish multicenter registry (BNP-PL). Ther Adv Chronic Dis. 2021 Mar 25;12:20406223211002961. doi: 10.1177/20406223211002961. eCollection 2021.
PubMed 33854746
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL
- ClinicalTrials.gov ID
- NCT03959748
- Acronym / sponsor ID
- BNP-PL / 1/BNP-PL/2018
- Keywords
- Pulmonary Hypertension,, CTEPH, Pulmonary Arterial Hypertension, Registry, Data Base, Polish patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Polish Cardiology AssociationUniversity, hospital or other
- Collaborators
- Jagiellonian University
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The BNP-PL is a multicenter, observational study in which patients are prospectively followed in order to investigate clinical course and management of pulmonary hypertension in Poland.
All patients diagnosed with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension confirmed in right heart catheterization, will be eligible to participate in the study.
Detailed description
The BNP-PL Registry is an initiative of the Polish Cardiac Society Task Force for Pulmonary Vascular Diseases This study is conducted by the Polish Cardiac Society. All centers of pulmonary hypertension in Poland which are accredited by the National Health Fund have been invited to join the study. The data is administrated by the Jagiellonian University Medical College on the basis of an agreement between the Polish Cardiac Society, Jagiellonian University Medical College and pulmonary hypertension centres.
The goal is to describe current practice and outcomes in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
The data collection will have no impact on the way the patient is diagnosed and treated.
Collection of data on patients with pulmonary hypertension is carried out via the electronic platform.
No personal data is entered into the project database.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PAH adults | – | –Patients with pulmonary arterial hypertension who are at least 18 years old at study entry |
| PAH children | – | –Patients with pulmonary arterial hypertension who are at least 3 months old and are less than 18 years old at study entry |
| CTEPH | – | –Patients with chronic thromboembolic pulmonary hypertension who are at least 18 years old at study entry |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension treated in Polish centres of pulmonary hypertension accredited by the National Health Fund
Key inclusion criteria (6 listed)
- Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed after 1st March 2018 (incident cases) who:
- are aged > 3 months at the time of enrollment
- fulfill the following hemodinamic criteria: mean pulmonary arterial pressure (mPAP) of 25 mm Hg or more, mean pulmonary arterial wedge pressure (PAWP) or left ventricular end-diastolic pressure (PVEDP) of 15 mm Hg or less, pulmonary vascular resistance (PVR) of 3 Woods.
- Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed before 1st March 2018 (prevalent cases) who:
- are aged > 3 months at the time of enrollment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Since enrollment until at least 5 years.
The number of patients who die during the follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Derived from this study: PubMed 39528108Waligora M, Kurzyna M, Mularek-Kubzdela T, Skoczylas I, Chrzanowski L, Blaszczak P, Jaguszewski M, Kusmierczyk B, Ptaszynska K, Grzesk G, Mizia-Stec K, Malinowska E, Peregud-Pogorzelska M, Lewicka E, Tomaszewski M, Jachec W, Florczyk M, Mroczek E, Gasior Z, Pawlak A, Betkier-Lipinska K, Pruszczyk P, Widejko K, Zablocka W, Kopec G. Effects of beta-Blockers on the Outcomes in Patients With Pulmonary Arterial Hypertension Stratified by the Presence of Comorbid Conditions: A Multicenter Prospective Cohort Study: The Database of Pulmonary Hypertension in the Polish Population (BNP-PL). Chest. 2025 Apr;167(4):1171-1181. doi: 10.1016/j.chest.2024.10.051. Epub 2024 Nov 9.
- Derived from this study: PubMed 33854746Kopec G, Dzikowska-Diduch O, Mroczek E, Mularek-Kubzdela T, Chrzanowski L, Skoczylas I, Tomaszewski M, Peregud-Pogorzelska M, Karasek D, Lewicka E, Jachec W, Gasior Z, Blaszczak P, Ptaszynska-Kopczynska K, Mizia-Stec K, Biederman A, Zielinski D, Przybylski R, Kedzierski P, Waligora M, Roik M, Grabka M, Orlowska J, Araszkiewicz A, Banaszkiewicz M, Slawek-Szmyt S, Darocha S, Magon W, Dabrowska-Kugacka A, Stepniewski J, Jonas K, Kaminski K, Kasprzak JD, Podolec P, Pruszczyk P, Torbicki A, Kurzyna M. Characteristics and outcomes of patients with chronic thromboembolic pulmonary hypertension in the era of modern therapeutic approaches: data from the Polish multicenter registry (BNP-PL). Ther Adv Chronic Dis. 2021 Mar 25;12:20406223211002961. doi: 10.1177/20406223211002961. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grzegorz Kopeć, MD, Phd principal investigator
Krakowski Szpital Specjalistyczny im. Jana Pawła II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by Polish Cardiology Association at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grzegorz Kopeć (+48 12 614 33 99, grzegorzkrakow1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Since enrollment until at least 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959748, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.