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DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL (BNP-PL)

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ClinicalTrials.gov Identifier: NCT03959748
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
Jagiellonian University
Information provided by (Responsible Party):
Polish Cardiology Association

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.


Condition or disease
Chronic Thromboembolic Pulmonary Hypertension Pulmonary Arterial 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2028


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



Primary Outcome Measures :
  1. Mortality [ Time Frame: Since enrollment until at least 5 years. ]
    The number of patients who die during the follow-up period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959748


Contacts
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Contact: Grzegorz Kopeć +48 12 614 33 99 grzegorzkrakow1@gmail.com
Contact: Magdalena Studnicka +48 602460707 mstudnicka@medicalartgroup.pl

Locations
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Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II Recruiting
Kraków, Poland, 31-202
Contact: Grzegorz Kopeć    +48 126143399    grzegorzkrakow1@gmail.com   
Sponsors and Collaborators
Polish Cardiology Association
Jagiellonian University
Investigators
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Principal Investigator: Grzegorz Kopeć, MD, Phd Krakowski Szpital Specjalistyczny im. Jana Pawła II

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Responsible Party: Polish Cardiology Association
ClinicalTrials.gov Identifier: NCT03959748     History of Changes
Other Study ID Numbers: 1/BNP-PL/2018
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Polish Cardiology Association:
Pulmonary Hypertension,
CTEPH
Pulmonary Arterial Hypertension
Registry
Data Base
Polish patients

Additional relevant MeSH terms:
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Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases