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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Actelion | INDUSTRY |
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The objectives of the current study are to identify and evaluate new prognostic non-invasive and serological markers in patients with pulmonary hypertension. The focus will be on L-arginine metabolism and to clarify its influence on endothelial function.
The objectives of the current study are to identify and evaluate new prognostic non-invasive and serological markers in patients with pulmonary hypertension. The focus will be on L-arginine metabolism and to clarify its influence on endothelial function. The investigators also want to evaluate differences in plasma concentrations of L-arginine/NO metabolites and non-invasively assessed endothelial function based on specific PH-therapy.
Furthermore, the investigators aim to transfer the results gained from the investigators study population to in-vitro systems in order to carefully characterize the involved signal transduction pathways. Thereby the investigators hope to identify potentially new therapeutic targets in PH or patient subgroups preferably benefitting from established therapeutic options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy-naive | Active Comparator | This group consists of patients with a newly diagnosed PH (Class I or IV). First blood sampling takes place before initiation of PH therapy (0 months), the following measurements will be performed after 3, 6, 9 and 12 months under specific therapy. Initiation of standard therapy is performed directly after baseline visit / study inclusion. No special study medication will be used. Intervention: a) Device: EndoPAT measurement and b) Biological/Vaccine: Blood Test |
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| Under therapy | Active Comparator | This group consists of patients under ERA monotherapy at timepoint of inclusion. Observation period is one year to detect intraindividual changes in endothelial dysfunction measured by L-arginine/NO-metabolites after 0, 3, 6, 9 and 12 months under investigation. Specific PAH therapy has been started prior to the study for medical reasons and will be continued throughout. Intervention: a) Device: EndoPAT measurement and b) Biological/Vaccine: Blood |
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| Healthy controls | Active Comparator | This group consists of healthy individuals. Sex and age matching is intended. Intervention: a) Device: EndoPAT measurement and b) Biological/Vaccine: Blood |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoPAT measurement | Device | EndoPAT (Itamar Medical Ltd, Ceasarea, Isreal) quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard blood pressure cuff). When the cuff is released, the surge of blood flow causes an endothelium-dependent Flow Mediated Dilatation (FMD). The dilatation, manifested as Reactive Hyperemia, is captured by EndoPAT as an increase in the PAT Signal amplitude. A post-occlusion to pre-occlusion ratio is calculated by the EndoPAT software, providing the EndoPAT index. EndoPAT is FDA-cleared and CE-marked. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of endothelial function regarding disease class and severity |
0 months = Time of Inclusion | 0, 3, 6, 9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of endothelial function with changes in pulmonary hemodynamics | L-arginine metabolite concentrations and PAT-Ratio correlated with PAPm, RAP, PVR (assessed by right heart catheterization within 12 months prior to inclusion) and echocardiographical parameters RVSP, TAPSE and TEI. | 0,3,6,9 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans FE Klose, MD | Department of Respiratory Medicine, University Medical Center Hamburg-Eppendorf | Study Director |
| Jan K Hennigs, MD | Department of Respiratory Medicine, University Medical Center Hamburg - Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Respiratory Medicine, University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
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| Label | URL |
|---|---|
| Link to Publication of Study Results | View source |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Blood Test | Biological | It is hypothesized that L-arginine/NO-metabolites are altered in pulmonary hypertension depending on disease severity. Moreover, polymorphisms in L-arginine/NO-metabolism modifying factors may influence disease severity. Analysis will be performed following established/published protocols after isolation from whole blood. |
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| Correlation of endothelial function with established prognostic factors |
L-arginine metabolite concentrations and PAT-Ratio correlated with plasma concentration of proBNP as well as capillary pCO2, 6-minute walk distance and NYHA/WHO functional class. |
| 0,3,6,9 and 12 months |
| Correlation of endothelial function with possible prognostic factors | L-arginine metabolite concentrations and PAT-Ratio correlated with plasma concentration of various enzymes as well as lung function. | 0,3,6,9 and 12 months |
| Correlation of L-arginine metabolites with pulmonary vascular signaling | In vitro evaluation of human pulmonary vasculature cells signaling and proliferation by altered L-arginine metabolite levels. | 0 months |
| Correlation of polymorphisms in L-arginine metabolism genes with disease severity | 0 months |
| Correlation of endothelial function with possible novel diagnostic or prognostic factors (e.g., inflammatory markers, intermediary metabolites) | 0 months |
| D002318 |
| Cardiovascular Diseases |