Database for Clinical and Anamnestic Data in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Database for Clinical and Anamnestic Data in Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01607502
• Other study ID #: 23-408 ex 10/11
• Status: Recruiting
• Start date: July 2010
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Medical University of Graz
• Contact: Horst Olschewski, MD
• Phone: +43-316-385-12183
• Email: horst.olschewski[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collecting data in a PH patient database	Retrospective and prospective data input and constant update	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)