Impact of Polymorphism on Pulmonary Pressure in Subjects With Pulmonary Hypertension of Different Cause

Sponsor
University of Leipzig (Other)
Overall Status
Completed
CT.gov ID
NCT00893178
Collaborator
Heart Center Leipzig - University Hospital (Other)
350
1
167
2.1

Study Details

Study Description

Brief Summary

Pulmonary Hypertension (PH) is a disease that is characterized by vasoconstriction of small vessels of the lung. Many cases do have proliferation of endothelial cells within these vessels. A possible influence of polymorphisms of genes relevant for inflammatory and endothelial processes is suspected.

Especially patients with chronic heart failure can develope PH. The reasons therefore are lacking.

The researchers investigate different polymorphism and the influence of these on pulmonary artery pressure (measured invasively) in patients with congestive heart failure (CHF) and patients with primary pulmonary hypertension.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study consists of 3 arms-patients with CHF and PH, patients with CHF without PH and patients without CHF and PH.

    The PH measurement is due to routine catheterization, thereafter we measure different vasoactive polymorphism.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    350 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Impact of Different Genetic Polymorphism on the Pulmonary Pressure in Patients With Pulmonary Hypertension of Different Cause With Special Focus on Patients With Chronic Heart Failure
    Actual Study Start Date :
    Dec 1, 2007
    Actual Primary Completion Date :
    Nov 1, 2021
    Actual Study Completion Date :
    Nov 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    CHF with elevated PAP

    CHF patients (LVEF > 35%) with elevated mean pulmonary pressure( > 20 mmHg ) measured by pa catheter

    CHF patient without elevated PAP

    CHF patients (LVEF > 35%) with normal mean pulmonary pressure

    Normal EF with elevated PAP

    Patients with normal LVEF < 60% with elevated mean pulmonary pressure

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of the Expression of Glu 298ASP Polymorphism with pulmonary pressure [Dec. 2010]

    Secondary Outcome Measures

    1. Rate of G308A TNF alpha polymorphism within the different groups [Dec. 2010]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • CHF with or without pulmonary hypertension or

    • patients with normal LVEF and pulmonary hypertension

    • right heart catheterization due to routine

    • informed consent

    Exclusion Criteria:
    • no right heart catheterization

    • no informed consent

    • elevated pulmonary pressure due to valve diseases or congenital heart disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heart Center Leipzig- University Leipzig Leipzig Germany 04289

    Sponsors and Collaborators

    • University of Leipzig
    • Heart Center Leipzig - University Hospital

    Investigators

    • Principal Investigator: Sven Möbius-Winkler, M.D, University Leipzig-Heart Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sven Möbius-Winkler, PI, University of Leipzig
    ClinicalTrials.gov Identifier:
    NCT00893178
    Other Study ID Numbers:
    • SMW 03
    First Posted:
    May 5, 2009
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Sven Möbius-Winkler, PI, University of Leipzig
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2021