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Completed

NCT Number: NCT03231774

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic heart failure NYHA I - IV

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Measurement of systolic, diastolic and mean CVP

    Time frame: During a single right heart catheterization procedure

    CVP measured in mmHg

Secondary outcomes

  1. Measurement of systolic, diastolic and mean PAP

    Time frame: During a single right heart catheterization procedure

    PAP measured in mmHg

  2. Measurement of systolic, diastolic and mean RVP

    Time frame: During a single right heart catheterization procedure

    RVP measured in mmHg

  3. Measurement of systolic, diastolic and mean PAWP

    Time frame: During a single right heart catheterization procedure

    PAWP measured in mmHg

  4. Measurement of Cardiac Index CI

    Time frame: During a single right heart catheterization procedure

    CI measured in l/M/m²

  5. Measurement of Cardiac Output CO

    Time frame: During a single right heart catheterization procedure

    CO measured in l/min

  6. Transthoracic Echocardiography

    Time frame: During a single TTE examination

    Collected data will be analyzed for comparability

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 27, 2017
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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