Serological and Non-invasive Evaluation of Endothelial Function in Patients With Pulmonary Arterial Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Differences of endothelial function regarding disease class and severity
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Therapy-naive
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
Intervention: EndoPAT measurement (Device)
Therapy-naive
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
Intervention: Blood Test (Biological)
Under therapy
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
Intervention: EndoPAT measurement (Device)
Under therapy
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
Intervention: Blood Test (Biological)
Healthy controls
This group consists of healthy individuals. Sex and age matching is intended. Intervention: a) Device: EndoPAT measurement and b) Biological/Vaccine: Blood
Intervention: EndoPAT measurement (Device)
Healthy controls
This group consists of healthy individuals. Sex and age matching is intended. Intervention: a) Device: EndoPAT measurement and b) Biological/Vaccine: Blood
Intervention: Blood Test (Biological)
Outcomes
Primary Outcomes
Differences of endothelial function regarding disease class and severity
Time Frame: 0, 3, 6, 9 and 12 months
1. Quantification of L-arginine metabolites in whole blood 2. PAT-Ratio as non-invasively assessed endothelial function by EndoPAT2000-Device (Itamar Medical Ltd., Caesarea, Israel) 0 months = Time of Inclusion
Secondary Outcomes
- Correlation of L-arginine metabolites with pulmonary vascular signaling(0 months)
- Correlation of endothelial function with changes in pulmonary hemodynamics(0,3,6,9 and 12 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)
- Correlation of endothelial function with established prognostic factors(0,3,6,9 and 12 months)
- Correlation of endothelial function with possible prognostic factors(0,3,6,9 and 12 months)