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

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.

Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Database for Clinical and Anamnestic Data in Pulmonary Hypertension

Resource links provided by NLM:

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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

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.

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)
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 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01607502

Contact: Horst Olschewski, MD +43-316-385-12183
Contact: Maria Tscherner, MD +43-316-385-12183

Medical University of Graz Recruiting
Graz, Austria, 8010
Contact: Horst Olschewski, MD    +43-316-385-12183   
Contact: Maria Tscherner, MD    +43-316-385-12183   
Principal Investigator: Horst Olschewski, MD         
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Horst Olschewski, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz Identifier: NCT01607502     History of Changes
Other Study ID Numbers: 23-408 ex 10/11
Study First Received: April 13, 2012
Last Updated: September 7, 2015
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:
Pulmonary hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases processed this record on November 25, 2015