Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Database for Clinical and Anamnestic Data in Pulmonary Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01607502
First received: April 13, 2012
Last updated: April 3, 2014
Last verified: April 2014

April 13, 2012
April 3, 2014
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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
900
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
Both
18 Years and older
No
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
 
NCT01607502
23-408 ex 10/11
No
Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Horst Olschewski, MD Medical University of Graz
Medical University of Graz
April 2014

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