Assessing non-invasive heart function measurements using echocardiography
Comprehensive Hemodynamic Assessment Via Echocardiography: the Echodynamic Approach Compared to Right Heart Catheterization
This study is testing if a non-invasive heart test using ultrasound can give accurate results compared to a more invasive procedure for patients who need both tests done on the same day.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Locations | 3 sites (Bari and 2 other locations) |
| Trial ID | NCT06859047 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the accuracy of non-invasive hemodynamic parameter estimation through transthoracic echocardiography (TTE) in comparison to the invasive gold standard of right heart catheterization (RHC). Patients who require both TTE and RHC on the same day will be included, allowing for a direct comparison of results under identical hemodynamic conditions. The study will utilize mathematical formulas to derive echocardiographic parameters and assess their correlation with the invasive findings from RHC.
Who should consider this trial
Good fit: Ideal candidates are patients who clinically require both echocardiographic and invasive hemodynamic assessments on the same day.
Not a fit: Patients who do not need an invasive hemodynamic assessment or have incomplete hemodynamic evaluations will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer, non-invasive alternative for assessing heart function in patients.
How similar studies have performed: Other studies have shown promise in using non-invasive methods for hemodynamic assessment, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bari and 2 other locations
- Ospedale Generale regionale "F.Miulli" — Bari, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milan, Italy (Recruiting)
- IRCCS Policlinico San Matteo Pavia — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Carlo Garspardone, Medical Doctor
- Email: gaspardone.carlo@hsr.it
- Phone: +393389920314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.