Database for Clinical and Anamnestic Data in Pulmonary Hypertension

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25 mmHg measured in the right heart catheterization.

There are different forms of PH defined in the classification of Dana Point 2008.

PH is diagnosed with right heart catheterization but there are other non invasive methods which can be used for screening like the echocardiography, stress echocardiography and cardio pulmonary exercise testing. In the diagnosis process and in the follow up of PH patients biomarkers like NTproBNP are helpful. There are no specific biomarkers for the disease which can make the diagnosis process easier and predict prognosis.

The systematic data collection in a data base provides better information about patients in daily routine and clinical studies as well as in the design of new studies.

Condition or disease
Pulmonary Hypertension

Detailed Description:

In this study the investigators want to collect clinical data of PH patients and controls in a database as well as blood samples in a biobank. The combination of anamnestic and clinical data and biomarkers should provide a better characterization of our patients and should improve the analysis of the disease development of different PH forms and therapeutic aspects.

After given informed consent patients' data are entered in a database at different time points. The database includes parameter of several invasive and non-invasive investigations like right heart catheterization (RHC), echocardiography, ECG, pulmonary function tests, cardiorespiratory exercise testing, 6-minute walk test, computed tomography, MRI, polysomnography, blood gas analysis and laboratory data as well as demographic data of the patients.

The blood samples are taken during routine punctuation and are stored in our biobank.

Study Design

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Study Type :	Observational
Estimated Enrollment :	900 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Database for Clinical and Anamnestic Data in Pulmonary Hypertension
Study Start Date :	July 2010
Estimated Primary Completion Date :	July 2024
Estimated Study Completion Date :	July 2024

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Patients of our outpatient clinic; Patients who have an investigation in our outpatient clinic for pulmonary hypertension like a echocardiography, a right heart catheterization or a cardio pulmonary exercise testing

Outcome Measures

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Primary Outcome Measures :

1. Collecting data in a PH patient database [ Time Frame: After one year: first analysis of retrospectively collected data. Ongoing data collection: new data of patients who are already in the database, new patients (3-4 years) ]
   Retrospective and prospective data input and constant update

Biospecimen Retention:   Samples With DNA

Blood samples are collected and stored anonymously in our biobank if patients give their informed consent containing the option of DNA analysis.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients who come to our outpatient clinic with pulmonary haypertension, symptoms that may be caused by pulmonary hypertension and patients at risk for pulmonary hypertension

Criteria

Inclusion Criteria:

• patients with pulmonary hypertension
• patients at risk for getting pulmonary hypertension
• patients who have symptoms which my be due to pulmonary hypertension when we have their written informed consent.

Exclusion Criteria:

• patients without written informed consent

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Horst Olschewski, MD	+43-316-385-12183	horst.olschewski@medunigraz.at
Contact: Maria Tscherner, MD	+43-316-385-12183	m.tscherner@medunigraz.at

Locations

Austria
Medical University of Graz	Recruiting
Graz, Austria, 8010
Contact: Horst Olschewski, MD +43-316-385-12183 horst.olschewski@medunigraz.at
Contact: Maria Tscherner, MD +43-316-385-12183 m.tscherner@medunigraz.at
Principal Investigator: Horst Olschewski, MD

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator:	Horst Olschewski, MD	Medical University of Graz

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kovacs G, Avian A, Foris V, Tscherner M, Kqiku X, Douschan P, Bachmaier G, Olschewski A, Matucci-Cerinic M, Olschewski H. Use of ECG and Other Simple Non-Invasive Tools to Assess Pulmonary Hypertension. PLoS One. 2016 Dec 28;11(12):e0168706. doi: 10.1371/journal.pone.0168706. eCollection 2016.

Responsible Party:	Medical University of Graz
ClinicalTrials.gov Identifier:	NCT01607502 History of Changes
Other Study ID Numbers:	23-408 ex 10/11
First Posted:	May 30, 2012
Last Update Posted:	August 9, 2017
Last Verified:	August 2017

Keywords provided by Medical University of Graz:

Pulmonary hypertension; database; biomarker

Additional relevant MeSH terms:

Hypertension; Hypertension, Pulmonary; Vascular Diseases	Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases