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NCT03959748 Clinical Trial

DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL

Pulmonary Arterial Hypertension Clinical Trial

— BNP-PL  

Official title:
DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03959748
Other study ID # 1/BNP-PL/2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date February 28, 2028

Study information
Verified date May 2019
Source Polish Cardiology Association
Contact Grzegorz Kopec
Phone +48 12 614 33 99
Email grzegorzkrakow1@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date February 28, 2028
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Months and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Poland Krakowski Szpital Specjalistyczny im. Jana Pawla II Kraków

Sponsors (2)
Lead Sponsor Collaborator
Polish Cardiology Association Jagiellonian University

Country where clinical trial is conducted

Poland, 

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