Database for Clinical and Anamnestic Data in Pulmonary Hypertension

Recruiting

• Conditions: Pulmonary Hypertension

• Registration Number: NCT01607502
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collecting data in a PH patient database	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

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria