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Database for Clinical and Anamnestic Data in Pulmonary Hypertension

This study is currently recruiting participants.
Verified August 2017 by Medical University of Graz
Sponsor:
ClinicalTrials.gov Identifier:
NCT01607502
First Posted: May 30, 2012
Last Update Posted: August 9, 2017
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.
Information provided by (Responsible Party):
Medical University of Graz
  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

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 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
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 2024
Estimated Primary Completion Date: July 2024 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607502


Contacts
Contact: Horst Olschewski, MD +43-316-385-12183 horst.olschewski@medunigraz.at
Contact: Maria Tscherner, MD +43-316-385-12183 m.tscherner@medunigraz.at

Locations
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         
Sponsors and Collaborators
Medical University of Graz
Investigators
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
First Submitted: April 13, 2012
First Posted: May 30, 2012
Last Update Posted: August 9, 2017
Last Verified: August 2017

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