Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01317134
Other study ID # PNEU-PV3334/2009/UKE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2010
Est. completion date July 2016

Study information

Verified date August 2022
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
EndoPAT measurement
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.
Biological:
Blood Test
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.

Locations

Country Name City State
Germany Department of Respiratory Medicine, University Medical Center Hamburg-Eppendorf Hamburg

Sponsors (3)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf Actelion, Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT04076241 - Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension N/A
Completed NCT05521113 - Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Recruiting NCT04972656 - Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension N/A
Completed NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Active, not recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Completed NCT01959815 - Novel Screening Strategies for Scleroderma PAH
Recruiting NCT04266197 - Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study Phase 2
Active, not recruiting NCT06092424 - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA) N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Terminated NCT02060487 - Effects of Oral Sildenafil on Mortality in Adults With PAH Phase 4
Terminated NCT02253394 - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study Phase 4
Withdrawn NCT02958358 - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Withdrawn NCT01723371 - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children Phase 1/Phase 2
Not yet recruiting NCT01649739 - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost Phase 4
Unknown status NCT01712997 - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients Phase 3
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
Completed NCT00963027 - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT00963001 - Effect of Food on the Pharmacokinetics of Oral Treprostinil Phase 1