Echocardiography, TransthoracicTECHNCT06859047
The Echodynamic Approach
An observational study of Echocardiography, Transthoracic and Right-heart Hemodynamics, run by IRCCS Ospedale San Raffaele at 3 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, Transthoracic, Right-heart Hemodynamics
- How many people
- 200 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Jan 2023to 31 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical need for an invasive hemodynamic assessment and an echocardiographic evaluation on the same day
Who cannot join
- Incomplete hemodynamic assessment for any reason
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
Ospedale Generale regionale "F.Miulli"
Bari
Fabrizio Fortunato, +393489269237, fabrizio.fortunato1@gmail.com
- Recruiting
IRCCS Ospedale San Raffaele
Milan
Carlo Gaspardone, +393389920314, gaspardone.carlo@hsr.it
- Recruiting
IRCCS Policlinico San Matteo Pavia
Pavia
Alessandro Fasolino, +393385754572, alessandro.fasolino01@universitadipavia.it
About this study
Official title: Comprehensive Hemodynamic Assessment Via Echocardiography: the Echodynamic Approach Compared to Right Heart Catheterization
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?
Read the 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.
- Keywords
- hemodynamics, right heart catheterization, echocardiography, echodynamics
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Echocardiography, TransthoracicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Gaspardone, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859047
- Sponsor's protocol ID
- TECH-HSR-2025
- Acronym
- TECH
- Status last verified
- Mar 2025
- First submitted
- 22 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Hemodynamic Assessment Via Echocardiography: the Echodynamic Approach Compared to Right Heart Catheterization
- ClinicalTrials.gov ID
- NCT06859047
- Acronym / sponsor ID
- TECH / TECH-HSR-2025
- Keywords
- hemodynamics, right heart catheterization, echocardiography, echodynamics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Clinical need for an invasive hemodynamic assessment and an echocardiographic evaluation on the same day
Key exclusion criteria (1 listed)
- Incomplete hemodynamic assessment for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography, Transthoracic and Right-heart Hemodynamics, run by IRCCS Ospedale San Raffaele at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlo Garspardone, Medical Doctor (+393389920314, gaspardone.carlo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.