Database for Clinical and Anamnestic Data in Pulmonary Hypertension

NCT ID: NCT01607502

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2027-07-31

Brief Summary

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.

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.

Conditions

Pulmonary Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Horst Olschewski, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University of Graz

Graz, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Horst Olschewski, MD

Role: CONTACT

horst.olschewski@medunigraz.at

+43-316-385-12183

Maria Tscherner, MD

Role: CONTACT

m.tscherner@medunigraz.at

+43-316-385-12183

Facility Contacts

Horst Olschewski, MD

Role: primary

horst.olschewski@medunigraz.at

+43-316-385-12183

Maria Tscherner, MD

Role: backup

m.tscherner@medunigraz.at

+43-316-385-12183

References

Kovacs G, Avian A, Foris V, Tscherner M, Kqiku X, Douschan P, Bachmaier G, Olschewski A, Matucci-Cerinic M, Olschewski H. Use of ECG and Other Simple Non-Invasive Tools to Assess Pulmonary Hypertension. PLoS One. 2016 Dec 28;11(12):e0168706. doi: 10.1371/journal.pone.0168706. eCollection 2016.

Reference Type: DERIVED

PMID: 28030578 (View on PubMed)

Other Identifiers

23-408 ex 10/11

Identifier Type: -

Identifier Source: org_study_id