Database for Clinical and Anamnestic Data in Pulmonary Hypertension
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01607502|
Recruitment Status : Recruiting
First Posted : May 30, 2012
Last Update Posted : August 9, 2017
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|
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 Type :||Observational|
|Estimated Enrollment :||900 participants|
|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|
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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607502
|Contact: Horst Olschewski, MDemail@example.com|
|Contact: Maria Tscherner, MDfirstname.lastname@example.org|
|Medical University of Graz||Recruiting|
|Graz, Austria, 8010|
|Contact: Horst Olschewski, MD +43-316-385-12183 email@example.com|
|Contact: Maria Tscherner, MD +43-316-385-12183 firstname.lastname@example.org|
|Principal Investigator: Horst Olschewski, MD|
|Principal Investigator:||Horst Olschewski, MD||Medical University of Graz|