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DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL

P

Polish Cardiology Association

Status

Enrolling

Conditions

Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Arterial Hypertension

Study type

Observational

Funder types

Other

Identifiers

NCT03959748
1/BNP-PL/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,000 estimated patients

Sex

All

Ages

3+ months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

3,000 participants in 3 patient groups

PAH adults
Description:
Patients with pulmonary arterial hypertension who are at least 18 years old at study entry
PAH children
Description:
Patients with pulmonary arterial hypertension who are at least 3 months old and are less than 18 years old at study entry
CTEPH
Description:
Patients with chronic thromboembolic pulmonary hypertension who are at least 18 years old at study entry

Trial contacts and locations

1

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Central trial contact

Grzegorz Kopeć; Magdalena Studnicka

Data sourced from clinicaltrials.gov

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