Endothelial Function in Patients With Pulmonary Arterial Hypertension

NCT01317134

Last updated date
Study Location
Department of Respiratory Medicine, University Medical Center Hamburg-Eppendorf
Hamburg, , 20246, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Hypertension, Pulmonary Arterial Hypertension, Pathophysiology, Genetics
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Pulmonary Hypertension, Pulmonary Arterial Hypertension, Pathophysiology, GeneticsEndothelial Function in Patients With Pulmonary Arterial Hypertension
NCT01317134
  1. Hamburg,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Endothelial Function in Patients With Pulmonary Arterial Hypertension
Official Title  ICMJE Serological and Non-invasive Evaluation of Endothelial Function in Patients With Pulmonary Arterial Hypertension
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Hypertension, Pulmonary
  • Pulmonary Arterial Hypertension
  • Pathophysiology
  • Genetics
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: 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

    Interventions:
    • Device: EndoPAT measurement
    • Biological: Blood Test
  • Active Comparator: 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

    Interventions:
    • Device: EndoPAT measurement
    • Biological: Blood Test
  • Active Comparator: Healthy controls
    This group consists of healthy individuals. Sex and age matching is intended. Intervention: a) Device: EndoPAT measurement and b) Biological/Vaccine: Blood
    Interventions:
    • Device: EndoPAT measurement
    • Biological: Blood Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: March 15, 2011)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01317134
Other Study ID Numbers  ICMJE PNEU-PV3334/2009/UKE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE
  • Pfizer
  • Actelion
Investigators  ICMJE
Study Director:Hans FE Klose, MDDepartment of Respiratory Medicine, University Medical Center Hamburg-Eppendorf
Principal Investigator:Jan K Hennigs, MDDepartment of Respiratory Medicine, University Medical Center Hamburg - Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP