Endothelial Function in Patients With Pulmonary Arterial Hypertension

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Hypertension, Pulmonary; Genetics; Pulmonary Arterial Hypertension; Pathophysiology

Treatments: Device: EndoPAT measurement; Biological: Blood Test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01317134

PNEU-PV3334/2009/UKE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Therapy-naive

Active Comparator group

Description:

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

Treatment:

Device: EndoPAT measurement

Biological: Blood Test

Under therapy

Active Comparator group

Description:

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

Treatment:

Device: EndoPAT measurement

Biological: Blood Test

Healthy controls

Active Comparator group

Description:

This group consists of healthy individuals. Sex and age matching is intended. Intervention: a) Device: EndoPAT measurement and b) Biological/Vaccine: Blood

Treatment:

Device: EndoPAT measurement

Biological: Blood Test