NCT03959748

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress82%
Mar 2018Feb 2028

Study Start

First participant enrolled

March 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Expected
Last Updated

May 22, 2019

Status Verified

May 1, 2019

Enrollment Period

5 years

First QC Date

March 26, 2019

Last Update Submit

May 20, 2019

Conditions

Keywords

Pulmonary Hypertension,CTEPHPulmonary Arterial HypertensionRegistryData BasePolish patients

Outcome Measures

Primary Outcomes (1)

  • Mortality

    The number of patients who die during the follow-up period

    Since enrollment until at least 5 years.

Study Arms (3)

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

Eligibility Criteria

Age3 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, 31-202, Poland

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Grzegorz Kopeć, MD, Phd

    Krakowski Szpital Specjalistyczny im. Jana Pawła II

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2019

First Posted

May 22, 2019

Study Start

March 1, 2018

Primary Completion

February 28, 2023

Study Completion (Estimated)

February 28, 2028

Last Updated

May 22, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations