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DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL (BNP-PL)
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.
| Condition or disease |
|---|
| Chronic Thromboembolic Pulmonary Hypertension Pulmonary Arterial Hypertension |
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 Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 3000 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL |
| Actual Study Start Date : | March 1, 2018 |
| Estimated Primary Completion Date : | February 28, 2023 |
| Estimated Study Completion Date : | February 28, 2028 |
| Group/Cohort |
|---|
|
PAH adults
Patients with pulmonary arterial hypertension who are at least 18 years old at study entry
|
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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
|
- Mortality [ Time Frame: Since enrollment until at least 5 years. ]The number of patients who die during the follow-up period
| Ages Eligible for Study: | 3 Months and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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
| Contact: Grzegorz Kopeć | +48 12 614 33 99 | grzegorzkrakow1@gmail.com | |
| Contact: Magdalena Studnicka | +48 602460707 | mstudnicka@medicalartgroup.pl |
| Poland | |
| Krakowski Szpital Specjalistyczny im. Jana Pawła II | Recruiting |
| Kraków, Poland, 31-202 | |
| Contact: Grzegorz Kopeć +48 126143399 grzegorzkrakow1@gmail.com | |
| Principal Investigator: | Grzegorz Kopeć, MD, Phd | Krakowski Szpital Specjalistyczny im. Jana Pawła II |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | March 26, 2019 | ||||||||
| First Posted Date | May 22, 2019 | ||||||||
| Last Update Posted Date | May 22, 2019 | ||||||||
| Actual Study Start Date | March 1, 2018 | ||||||||
| Estimated Primary Completion Date | February 28, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Mortality [ Time Frame: Since enrollment until at least 5 years. ] The number of patients who die during the follow-up period
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL | ||||||||
| Official Title | DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL | ||||||||
| Brief 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. 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. |
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| 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 Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | 5 Years | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| 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 | ||||||||
| Condition |
|
||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
|
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| Publications * | Kopeć G, Dzikowska-Diduch O, Mroczek E, Mularek-Kubzdela T, Chrzanowski Ł, Skoczylas I, Tomaszewski M, Peregud-Pogorzelska M, Karasek D, Lewicka E, Jacheć W, Gąsior Z, Błaszczak P, Ptaszyńska-Kopczyńska K, Mizia-Stec K, Biederman A, Zieliński D, Przybylski R, Kędzierski P, Waligóra M, Roik M, Grabka M, Orłowska J, Araszkiewicz A, Banaszkiewicz M, Sławek-Szmyt S, Darocha S, Magoń W, Dąbrowska-Kugacka A, Stępniewski J, Jonas K, Kamiński 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. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
3000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | February 28, 2028 | ||||||||
| Estimated Primary Completion Date | February 28, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria: Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed after 1st March 2018 (incident cases) who:
Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed before 1st March 2018 (prevalent cases) who:
|
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| Sex/Gender |
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| Ages | 3 Months and older (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Poland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03959748 | ||||||||
| Other Study ID Numbers | 1/BNP-PL/2018 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Polish Cardiology Association | ||||||||
| Study Sponsor | Polish Cardiology Association | ||||||||
| Collaborators | Jagiellonian University | ||||||||
| Investigators |
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| PRS Account | Polish Cardiology Association | ||||||||
| Verification Date | May 2019 | ||||||||
