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NCT Number: NCT06859047

The Echodynamic Approach

The aim of this prospective observational study is to assess the accuracy of non-invasive hemodynamic parameter estimation via trans-thoracic echocardiography (TTE) compared to the invasive gold standard of right heart catheterization (RHC). This study will include patients who undergo both TTE and RHC on the same day, under the same hemodynamic conditions. The primary research question is: how does the echodynamic evaluation perform compared to right heart catheterization?

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Key information

Conditions

Echocardiography, Transthoracic Right-heart Hemodynamics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Generale regionale "F.Miulli", Bari, Italy

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About this study

The non-invasive echocardiographic assessment will be used to esimate via mathematic formulas all the direct and indirect paramethers obtained from the right side catheterization. Each value obtained from the model using echocardiographic paramethers will be compared to the invasive finding.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical need for an invasive hemodynamic assessment and an echocardiographic evaluation on the same day

Exclusion criteria

  • Incomplete hemodynamic assessment for any reason

Treatment and study plan

Primary outcomes

  1. Cardiac output

    Time frame: Baseline

    The primary outcome will be to compare the estimated value using echocardiographic parameters with the same invasive measurement by right heart catheterization recorded on the same day to avoid different cardiac load conditions. Right heart catheterization will be from either femural or jugular vein approach. The measure's unit will be L/min and L/min/m^2 for the indexed value.

  2. Pulmonary artery pressure

    Time frame: Baseline

    The primary outcome will be to compare the estimated values using echocardiographic parameters with the same invasive measurement by right heart catheterization recorded on the same day to avoid different cardiac load conditions. Right heart catheterization will be from either femural or jugular vein approach. The measure's unit will be in mmHg, and it will be expressed as systolic, mean and diastolic pulmonary pressure.

  3. Pulmonary vascular resistance

    Time frame: Baseline

    The primary outcome will be to compare the estimated values using echocardiographic parameters with the same invasive measurement by right heart catheterization recorded on the same day to avoid different cardiac load conditions. Right heart catheterization will be from either femural or jugular vein approach. The measure's unit will be in Woods Units

  4. Right atrial pressure

    Time frame: Baseline

    The primary outcome will be to compare the estimated values using echocardiographic parameters with the same invasive measurement by right heart catheterization recorded on the same day to avoid different cardiac load conditions. Right heart catheterization will be from either femural or jugular vein approach. The measure's unit will be in mmHg.

Study contacts

Contact information is provided by the study sponsor or research team.

Carlo Garspardone, Medical Doctor

CONTACT

[email protected]

+393389920314

Sponsors and collaborators

Lead sponsor

IRCCS Ospedale San Raffaele

Other

Registry information

Official study title

Comprehensive Hemodynamic Assessment Via Echocardiography: the Echodynamic Approach Compared to Right Heart Catheterization

Acronym: TECH

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Mar 18, 2025

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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