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Database for Clinical and Anamnestic Data in Pulmonary Hypertension
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Purpose
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 |
|---|
| Pulmonary Hypertension |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Database for Clinical and Anamnestic Data in Pulmonary Hypertension |
- 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
| Estimated Enrollment: | 900 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | July 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01607502
| Contact: Horst Olschewski, MD | +43-316-385-12183 | horst.olschewski@medunigraz.at | |
| Contact: Maria Tscherner, MD | +43-316-385-12183 | m.tscherner@medunigraz.at |
| 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 | |
| Principal Investigator: | Horst Olschewski, MD | Medical University of Graz |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical University of Graz |
| ClinicalTrials.gov Identifier: | NCT01607502 History of Changes |
| Other Study ID Numbers: |
23-408 ex 10/11 |
| Study First Received: | April 13, 2012 |
| Last Updated: | November 29, 2016 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017