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Database for Clinical and Anamnestic Data in Pulmonary Hypertension

This study is currently recruiting participants.
Verified April 2013 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 9, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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 2016
Estimated Primary Completion Date: July 2013 (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 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
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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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: April 9, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

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 May 16, 2013