Pulmonary Arterial Hypertension Clinical Trial
Official title:
Serological and Non-invasive Evaluation of Endothelial Function in Patients With Pulmonary Arterial Hypertension
Verified date | August 2022 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | July 2016 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - proven PH (by right heart catheterization, PAP >25 mmHg, within last 12 months) - age >18 years - Dana Point classification I or IV (all subgroups) - declaration of consent Exclusion Criteria: - Pulmonary Hypertension not proven by right heart catheterization - Eisenmenger's syndrome/reaction - PH other than Dana Point I and IV - alcohol or drug abuse - non-compliance due to any cause (e.g. severe psychiatric disorder) |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Respiratory Medicine, University Medical Center Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf | Actelion, Pfizer |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences of endothelial function regarding disease class and severity | Quantification of L-arginine metabolites in whole blood
PAT-Ratio as non-invasively assessed endothelial function by EndoPAT2000-Device (Itamar Medical Ltd., Caesarea, Israel) 0 months = Time of Inclusion |
0, 3, 6, 9 and 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Correlation of polymorphisms in L-arginine metabolism genes with disease severity | 0 months | ||
Secondary | Correlation of endothelial function with possible novel diagnostic or prognostic factors (e.g., inflammatory markers, intermediary metabolites) | 0 months |
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