Database for Clinical and Anamnestic Data in Pulmonary Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Medical University of Graz
Information provided by (Responsible Party):
Medical University of Graz Identifier:
First received: April 13, 2012
Last updated: September 7, 2015
Last verified: September 2015

April 13, 2012
September 7, 2015
July 2010
July 2017   (final data collection date for primary outcome measure)
Collecting data in a PH patient database [ Time Frame: After one year: first analysis of retrospectivly collected data. Ongoing data collectioncontion: new data of patients who are allready in the database, new patients (3-4 years) ] [ Designated as safety issue: No ]
Retrospective and prospective datainput and constant update
Same as current
Complete list of historical versions of study NCT01607502 on Archive Site
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Database for Clinical and Anamnestic Data in Pulmonary Hypertension
Database for Clinical and Anamnestic Data in Pulmonary Hypertension

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.

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 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.

Observational Model: Cohort
Time Perspective: Prospective
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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.
Non-Probability Sample
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
Pulmonary Hypertension
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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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2017
July 2017   (final data collection date for primary outcome measure)

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
18 Years and older
Contact: Horst Olschewski, MD +43-316-385-12183
Contact: Maria Tscherner, MD +43-316-385-12183
23-408 ex 10/11
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Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Horst Olschewski, MD Medical University of Graz
Medical University of Graz
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP