The Echodynamic Approach

NCT06859047 | Recruiting

• 1 other identifier: TECH-HSR-2025
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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?

Conditions

Echocardiography, Transthoracic; Right-heart Hemodynamics

Keywords

hemodynamics; right heart catheterization; echocardiography; echodynamics

Outcome Measures

Primary Outcomes (4)

• Cardiac output

  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.

  Baseline

• Pulmonary artery pressure

  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.

  Baseline

• Pulmonary vascular resistance

  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

  Baseline

• Right atrial pressure

  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.

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients from multiple centers who received, within a short time frame (the same day), an invasive assessment of hemodynamic parameters through right heart catheterization and a non-invasive assessment through echocardiography.

You may qualify if:

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

You may not qualify if:

• Incomplete hemodynamic assessment for any reason

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Study Sites (3)

Ospedale Generale regionale "F.Miulli"

Bari, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

IRCCS Policlinico San Matteo Pavia

Pavia, Italy

RECRUITING

Central Study Contacts

Carlo Garspardone, Medical Doctor

CONTACT

+393389920314; gaspardone.carlo@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: March 5, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

IT (3)