The Echodynamic Approach

NCT ID: NCT06859047

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Echocardiography, Transthoracic Right-heart Hemodynamics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Ospedale San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Carlo Gaspardone

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedale Generale regionale "F.Miulli"

Bari, , Italy

Site Status RECRUITING

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

IRCCS Policlinico San Matteo Pavia

Pavia, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Carlo Garspardone, Medical Doctor

Role: CONTACT

+393389920314

Facility Contacts

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Fabrizio Fortunato

Role: primary

+393489269237

Carlo Gaspardone

Role: primary

+393389920314

Alessandro Fasolino

Role: primary

+393385754572

Other Identifiers

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TECH-HSR-2025

Identifier Type: -

Identifier Source: org_study_id

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