Trial Outcomes & Findings for Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD (NCT NCT05186415)

Last Updated: 2025-11-28

Results Overview

Echocardiography derived measurements of right ventricular end-diastolic volume, end-systolic volume, with and without contrast, and MRI derived values in patients with repaired congenital heart disease

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

All images were obtained on the same day of the study. MRI analysis performed by clinical reading attending. Echo analysis performed offline after completing of imaging.

Results posted on

2025-11-28

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic Arm The echocardiography team will perform baseline echocardiographic views of the right ventricle without contrast. The patient will receive the weight-based dose of Lumason of 0.03 mL/kg per injection, not to exceed 2.4 mL per injection per the FDA and manufacturer recommendations. Dosages and timing of administration as well as patient size and transducer type will be recorded for each patient. The total cumulative dose of Lumason from the clinical study and the research study will not exceed the maximum recommended dose by the manufacturer, 4.8 mL. A single injection will not exceed the maximal FDA-recommended dose of 2.4 mL per single injection. These echocardiographic views of the right ventricle with ultrasound enhancing agent will be compared to the measurements made without the use of ultrasound enhancing agents, and the measurements made in MRI. Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension \[LUMASON\]: The patient will receive the weight-based dose of Lumason of 0.03 mL/kg per injection, not to exceed 2.4 mL per injection per the FDA and manufacturer recommendations.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic Arm n=25 Participants Contrast enhanced 3D echo (Lumason)
Age, Categorical <=18 years	11 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants
Sex: Female, Male Female	11 Participants n=30 Participants
Sex: Female, Male Male	14 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	2 Participants n=30 Participants
Race (NIH/OMB) White	22 Participants n=30 Participants
Race (NIH/OMB) More than one race	1 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants
Region of Enrollment United States	25 participants n=30 Participants
Diagnosis Tetralogy of Fallot	9 Participants n=30 Participants
Diagnosis Pulmonary atresia with intact ventricular septum	4 Participants n=30 Participants
Diagnosis Pulmonary stenosis	7 Participants n=30 Participants
Diagnosis Truncus arteriosus	2 Participants n=30 Participants
Diagnosis Other	3 Participants n=30 Participants

PRIMARY outcome

Timeframe: All images were obtained on the same day of the study. MRI analysis performed by clinical reading attending. Echo analysis performed offline after completing of imaging.

Population: Two patients were unable to be analyzed for either the contrast or non-contrast group due to imaging quality and lack of complete 3D echo dataset

Outcome measures

Outcome measures
Measure	Non-contrast 3D Echo n=21 Participants Images from non-contrast 3D echo analyzed for RV volume	Contrast Echo n=17 Participants Contrast enhanced 3D echo (Lumason)	Cardiac MRI n=24 Participants Measurements from clinically obtained cardiac MRI
Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Size Compared to MRI Derived Values. RV End-Diastolic Volume (ml)	187.1 ml Standard Deviation 55.3	175.4 ml Standard Deviation 53.3	205.0 ml Standard Deviation 51.6
Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Size Compared to MRI Derived Values. RV End-Systolic Volume (ml)	86.0 ml Standard Deviation 32.1	84.8 ml Standard Deviation 27.5	100.0 ml Standard Deviation 32.2

PRIMARY outcome

Timeframe: All images were obtained on the same day of the study. MRI analysis performed by clinical reading attending. Echo analysis performed offline after completing of imaging.

Population: Two patients were unable to be analyzed for either the contrast or non-contrast group due to imaging quality and lack of complete 3D echo dataset

Echocardiography derived measurements of right ventricular ejection fraction, with and without contrast, and MRI derived values in patients with repaired congenital heart disease

Outcome measures

Outcome measures
Measure	Non-contrast 3D Echo n=21 Participants Images from non-contrast 3D echo analyzed for RV volume	Contrast Echo n=17 Participants Contrast enhanced 3D echo (Lumason)	Cardiac MRI n=24 Participants Measurements from clinically obtained cardiac MRI
Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Function Compared to MRI Derived Values.	52 percentage Standard Deviation 13.8	52.6 percentage Standard Deviation 5.9	51.9 percentage Standard Deviation 6.5

PRIMARY outcome

Timeframe: All echocardiographic images obtained on the day of the study participation. Analysis done offline.

The agreement of echocardiography derived measurements of right ventricular end-diastolic volume, end-systolic volume, and ejection fraction, with and without contrast, will be compared between the two readers using the intraclass correlation coefficient.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Echocardiography and MRI images obtained on the day of study participation. Analysis done after image acquisition complete

Population: Images with sufficient quality were analyzed to obtain Global longitudinal strain values (expressed as a percentage)

3D echocardiography measurement of right ventricular strain will be compared with MRI derived RV strain in patients with repaired congenital heart disease using an intraclass correlation coefficient.

Outcome measures

Outcome measures
Measure	Non-contrast 3D Echo n=16 Participants Images from non-contrast 3D echo analyzed for RV volume	Contrast Echo n=10 Participants Contrast enhanced 3D echo (Lumason)	Cardiac MRI n=24 Participants Measurements from clinically obtained cardiac MRI
Comparing Echocardiographic and MRI Derived Right Ventricular Strain Measurement.	23.1 percentage strain Standard Deviation 4.8	21.3 percentage strain Standard Deviation 5.0	18.1 percentage strain Standard Deviation 4.7

Adverse Events

Diagnostic Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diagnostic Arm n=25 participants at risk Contrast enhanced 3D echo (Lumason) Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension \[LUMASON\]: The patient will receive the weight-based dose of Lumason of 0.03 mL/kg per injection, not to exceed 2.4 mL per injection per the FDA and manufacturer recommendations.
Musculoskeletal and connective tissue disorders chest pain	4.0% 1/25 • Number of events 1 • 30 minutes

Additional Information

Shannon Nees, MD

Nemours Children's Hospital, Delaware

Phone: 302-651-6600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place