Database for Clinical and Anamnestic Data in Pulmonary Hypertension

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension

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 Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Horst Olschewski, MD; Phone Number: +43-316-385-12183; Email: horst.olschewski@medunigraz.at
• Study Contact Backup: Name: Maria Tscherner, MD; Phone Number: +43-316-385-12183; Email: m.tscherner@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8010
    • Recruiting
    • Medical University of Graz
    • Contact: Horst Olschewski, MD; Phone Number: +43-316-385-12183; Email: horst.olschewski@medunigraz.at
    • Principal Investigator: Horst Olschewski, MD
    • Contact: Maria Tscherner, MD; Phone Number: +43-316-385-12183; Email: m.tscherner@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Medical University of Graz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: April 13, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (Estimate): May 30, 2012

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: biomarker; Pulmonary hypertension; database
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 23-408 ex 10/11