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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension

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
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Grzegorz Kopeć; Phone Number: +48 12 614 33 99; Email: grzegorzkrakow1@gmail.com
• Study Contact Backup: Name: Magdalena Studnicka; Phone Number: +48 602460707; Email: mstudnicka@medicalartgroup.pl

Study Locations

• Poland
  • Kraków, Poland, 31-202
    • Recruiting
    • Krakowski Szpital Specjalistyczny im. Jana Pawła II
    • Contact: Grzegorz Kopeć; Phone Number: +48 126143399; Email: grzegorzkrakow1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	The number of patients who die during the follow-up period	Since enrollment until at least 5 years.

Collaborators and Investigators

• Sponsor: Polish Cardiology Association
• Collaborators: Jagiellonian University
• Investigators: Principal Investigator: Grzegorz Kopeć, MD, Phd, Krakowski Szpital Specjalistyczny im. Jana Pawła II

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2028

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Registry; Pulmonary Arterial Hypertension; CTEPH; Pulmonary Hypertension,; Data Base; Polish patients
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 1/BNP-PL/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No