Clinical trial NCT01317134: Endothelial Function in Patients With Pulmonary Arterial Hypertension
Official title: Serological and Non-invasive Evaluation of Endothelial Function in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Pathophysiology
Genetics
Keywords: Pulmonary Arterial Hypertension
Prognostic factors
Signal transduction
Genetics
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Actelion
First posted: 2011-03-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Differences of endothelial function regarding disease class and severity
timeFrame: 0, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Correlation of endothelial function with changes in pulmonary hemodynamics
timeFrame: 0,3,6,9 and 12 months
measure: Correlation of endothelial function with established prognostic factors
timeFrame: 0,3,6,9 and 12 months
measure: Correlation of endothelial function with possible prognostic factors
timeFrame: 0,3,6,9 and 12 months
measure: Correlation of L-arginine metabolites with pulmonary vascular signaling
timeFrame: 0 months
measure: Correlation of polymorphisms in L-arginine metabolism genes with disease severity
timeFrame: 0 months
measure: Correlation of endothelial function with possible novel diagnostic or prognostic factors (e.g., inflammatory markers, intermediary metabolites)
timeFrame: 0 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Respiratory Medicine, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Department of Respiratory Medicine, University Medical Center Hamburg-Eppendorf
name: Hans FE Klose, MD
role: STUDY_DIRECTOR
affiliation: Department of Respiratory Medicine, University Medical Center Hamburg - Eppendorf
name: Jan K Hennigs, MD
role: PRINCIPAL_INVESTIGATOR
References: