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Database for Clinical and Anamnestic Data in Pulmonary Hypertension

M

Medical University of Graz

Status

Enrolling

Conditions

Pulmonary Hypertension

Study type

Observational

Funder types

Other

Identifiers

NCT01607502
23-408 ex 10/11

Details and patient eligibility

About

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.

Full 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.

Enrollment

900 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

900 participants in 1 patient group

Patients of our outpatient clinic
Description:
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

Trial contacts and locations

1

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Central trial contact

Horst Olschewski, MD; Maria Tscherner, MD

Data sourced from clinicaltrials.gov

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