The Echodynamic Approach

Recruiting

• Conditions: Echocardiography, Transthoracic; Right-heart Hemodynamics

• Registration Number: NCT06859047
• Lead Sponsor: IRCCS Ospedale San Raffaele

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2025-02-22
• Study First Submitted QC: 2025-02-27
• Status Verified: 2025-03
• Study First Posted: 2025-03-05
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac output	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.
Pulmonary artery pressure	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.
Pulmonary vascular resistance	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
Right atrial pressure	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.

Trial Locations

Locations (3)

Ospedale Generale regionale "F.Miulli"; 🇮🇹 Bari, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy

IRCCS Policlinico San Matteo Pavia; 🇮🇹 Pavia, Italy