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Non-invasive Assessment of Pulmonary Artery Pressure

Sponsor
Medical University of Graz (Other)
Overall Status
Completed
CT.gov ID
NCT02223559
Collaborator
National Bank of Austria (Other), Ludwig Boltzmann Institute for Lung Vascular Research (Other)
90
Enrollment
1
Location
34
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The assessment of pulmonary artery pressure (PAP) and parameters describing right ventricular function stand in the focus of the diagnosis and clinical management of pulmonary hypertension (PH). Right heart catheterization (RHC) is the gold standard method to measure PAP and to provide hemodynamic information on right ventricular function. However, due to its invasive nature, RHC is not optimal for screening and for close monitoring of the disease. Therefore, the development of non-invasive methods providing reliable PAP measurements and right ventricular functional parameters would be of major benefit.

Today, the most often used comprehensive non-invasive method for these purposes is echocardiography. However, the method has limitations; in many cases PAP is significantly under- or overestimated - especially in subjects with co-existing pulmonary diseases. Regarding right ventricular function, although novel echocardiography parameters appear to be promising, they have not yet been evaluated in all forms of PH.

Another emerging non-invasive method is cardiac magnetic resonance imaging (MRI). MRI is considered to be as gold standard for the non-invasive assessment of right ventricular function. In addition, our group showed that with a special approach ("vortex method"), MRI enables the determination of PAP with physiologic accuracy, but the method has not yet been validated systematically in different forms of PH.

All patients undergoing right heart catheterization in our clinic are candidates for the study. Excluded will be patients not eligible for MRI or declining to take part in the study. MRI and Echocardiography will be performed within two weeks of the RHC.

Hypothesis:

  1. MRI is superior to echocardiography to non-invasively determine mean PAP in a broad collective of patients with PH of diverse ethology.

  2. MRI derived right ventricular functional parameters correlate better to invasive measurements and to established prognostic parameters than echocardiography derived right ventricular functional parameters.

  3. Novel right ventricular tissue Doppler parameters add substantially to "classical" echocardiography parameters to describe right ventricular function.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Non-invasive Assessment of Pulmonary Artery Pressure and Right Ventricular Function in Patients With Pulmonary Hypertension
    Study Start Date :
    Aug 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2017
    Actual Study Completion Date :
    Jun 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    right heart catheterization patients

    Outcome Measures

    Primary Outcome Measures

    1. mean pulmonary artery pressure [at baseline]

    Secondary Outcome Measures

    1. right ventricular function parameters [at baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: patients undergoing right heart catheterization due to clinical reasons

    Exclusion Criteria: patients not eligible for MRI, patients not agreeing with investigation

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Graz Graz Austria 8036

    Sponsors and Collaborators

    • Medical University of Graz
    • National Bank of Austria
    • Ludwig Boltzmann Institute for Lung Vascular Research

    Investigators

    • Principal Investigator: Horst Olschewski, Prof., Medical University of Graz

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT02223559
    Other Study ID Numbers:
    • 25-593 ex 12/13
    First Posted:
    Aug 22, 2014
    Last Update Posted:
    Aug 9, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:
    Hypertension, Pulmonary
    Hypertension

    Study Results

    No Results Posted as of Aug 9, 2017