Phase 2
N=25
Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD
Tetralogy of Fallot · Pulmonary Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT05186415 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Size Compared to MRI Derived Values. — 187.1; 175.4; 205.0; 86.0 ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] (Drug)
- Age
- Pediatric, Adult, Older Adult · 11+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Size Compared to MRI Derived Values. |
187.1; 175.4; 205.0; 86.0; 84.8; 100.0 | — |
| PRIMARY Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Function Compared to MRI Derived Values. |
52; 52.6; 51.9 | — |
| PRIMARY Inter-rater Reliability of 3D Echocardiography Based Measurements of Right Ventricular Size and Function With and Without Contrast |
— | — |
| SECONDARY Comparing Echocardiographic and MRI Derived Right Ventricular Strain Measurement. |
23.1; 21.3; 18.1 | — |
Summary
We propose the novel integration of two echocardiographic technologies - three-dimensional echocardiography using semi-automated right ventricular analysis coupled with the administration of ultrasound enhancing agents - to improve the inter-rater reliability and accuracy of various measures of right ventricular size and function, compared with cardiac MRI.
Eligibility Criteria
Inclusion Criteria
- All patients aged 11 or greater with repaired congenital heart disease and residual pulmonary insufficiency who are referred to Nemours A.I. DuPont Hospital for Children for clinically indicated cardiac MRI will be eligible for inclusion.
- Informed written consent of parent or legal guardian.
- Informed written assent of subject, if appropriate.
Exclusion Criteria
- Any patients in which Lumason is contraindicated (i.e. prior anaphylactoid reaction) will be ineligible for the clinical ultrasound and ineligible for the study.
- History of allergic reaction to Lumason, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
- Pregnant women will be excluded from the study as well since Lumason has not been studied in pregnancy.
Data sourced from ClinicalTrials.gov (NCT05186415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.