Clinical trial NCT03959748: DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL
Official title: DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Arterial Hypertension
Keywords: Pulmonary Hypertension,
CTEPH
Pulmonary Arterial Hypertension
Registry
Data Base
Polish patients
Lead sponsor: Polish Cardiology Association
Sponsor class: OTHER
Collaborators: name: Jagiellonian University
First posted: 2019-05-22
Enrollment: 3000
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: Since enrollment until at least 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II
Study officials:
affiliation: Krakowski Szpital Specjalistyczny im. Jana Pawła II
name: Grzegorz Kopeć, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kopec 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.