Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD

Completed · Phase 1/Phase 2

Conditions studied: Tetralogy of Fallot, Pulmonary Insufficiency

In brief

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.

Key facts

Study ID

NCT05186415

Run by

Nemours Children's Clinic

People needed

25

Starts

2022-08-23

Expected to finish

2024-06-25

Last updated by the study team

2026-04-27

Who can join

Age: 11 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Nemours Childrens Hospital — Wilmington, Delaware, United States

Full record on ClinicalTrials.gov

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