Database for Clinical and Anamnestic Data in Pulmonary Hypertension
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| First Received Date ICMJE | April 13, 2012 | ||||||||
| Last Updated Date | April 9, 2013 | ||||||||
| Start Date ICMJE | July 2010 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Collecting data in a PH patient database [ Time Frame: After one year: first analysis of retrospectivly collected data. Ongoing data collectioncontion: new data of patients who are allready in the database, new patients (3-4 years) ] [ Designated as safety issue: No ] Retrospective and prospective datainput and constant update |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01607502 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Database for Clinical and Anamnestic Data in Pulmonary Hypertension | ||||||||
| Official Title ICMJE | Database for Clinical and Anamnestic Data in Pulmonary Hypertension | ||||||||
| 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. |
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| 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 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Blood samples are collected and stored anonymously in our biobank if patients give their informed consent containing the option of DNA analysis. |
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| 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 |
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| Condition ICMJE | Pulmonary Hypertension | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | 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 |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 900 | ||||||||
| Estimated Completion Date | July 2016 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01607502 | ||||||||
| Other Study ID Numbers ICMJE | 23-408 ex 10/11 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Medical University of Graz | ||||||||
| Study Sponsor ICMJE | Medical University of Graz | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Graz | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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