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Comparability of Hemodynamic Parameters Measured by Non-invasive Echocardiography and by Right Heart Catheterization

Sponsor
Heart and Diabetes Center North-Rhine Westfalia (Other)
Overall Status
Completed
CT.gov ID
NCT03231774
Collaborator
(none)
100
Enrollment
1
Location
12.3
Actual Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to compare transthoracic Echocardiography TTE to the gold standard Right Heart Catheterization in Terms of accuracy to measure hemodynamic parameters.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Chronic heart failure is a progressive disease in Western population. Echocardiography and right heart catheterization are important tools in the diagnosis and progress monitoring of heart failure.

    Gold standard in diagnosis of hemodynamic parameters in patients with heart failure is right heart catheterization. However, this diagnostic device represents an invasive method that is additionally associated with high risks such as infections, vessel and nerve injuries. Echocardiography is probably in a position to determine hemodynamic parameters as reliably as right heart catheterization without additional health risk due to its non-invasive character. All procedures performed are part of clinical Routine. Patients do not undergo any study-specific procedure at all.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparability of Hemodynamic Parameters Measured by Non-invasive Echocardiography and by Right Heart Catheterization
    Actual Study Start Date :
    Jul 21, 2017
    Actual Primary Completion Date :
    Dec 31, 2017
    Actual Study Completion Date :
    Jul 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of systolic, diastolic and mean CVP [During a single right heart catheterization procedure]

      CVP measured in mmHg

    Secondary Outcome Measures

    1. Measurement of systolic, diastolic and mean PAP [During a single right heart catheterization procedure]

      PAP measured in mmHg

    2. Measurement of systolic, diastolic and mean RVP [During a single right heart catheterization procedure]

      RVP measured in mmHg

    3. Measurement of systolic, diastolic and mean PAWP [During a single right heart catheterization procedure]

      PAWP measured in mmHg

    4. Measurement of Cardiac Index CI [During a single right heart catheterization procedure]

      CI measured in l/M/m²

    5. Measurement of Cardiac Output CO [During a single right heart catheterization procedure]

      CO measured in l/min

    6. Transthoracic Echocardiography [During a single TTE examination]

      Collected data will be analyzed for comparability

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Chronic heart failure NYHA I - IV
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herz- und Diabeteszentrum NRW Bad Oeynhausen NRW Germany 32545

    Sponsors and Collaborators

    • Heart and Diabetes Center North-Rhine Westfalia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heart and Diabetes Center North-Rhine Westfalia
    ClinicalTrials.gov Identifier:
    NCT03231774
    Other Study ID Numbers:
    • HDZ-KA_011_HF
    First Posted:
    Jul 27, 2017
    Last Update Posted:
    Oct 9, 2020
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Heart and Diabetes Center North-Rhine Westfalia
    Echocardiography
    Right heart catheterization
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Oct 9, 2020