This is a Phase 3, prospective, open-label, multicenter study to assess the efficacy of NH002-enhanced echocardiography in subjects with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the left ventricular endocardial border delineation compared with unenhanced echocardiography. The study also aims to investigate the safety and tolerability of NH002.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.
Keelung Chang Gung Memorial Hospital & Lovers Lake Branch
Keelung, Taiwan
China Medical University Hospital
Taichung, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
Cathay General Hospital
Taipei, Taiwan
Left Ventricular Endocardial Border Delineation (LVEBD)
The first primary efficacy endpoint will be the change from baseline in total LVEBD scores (UEUS vs CEUS) defined using a 16-segment model derived from the standard 17-segment model, as assessed through blinded central reading. The LV endocardium of the standard apical 4-, 2-, and 3-chamber views is divided into 6 segments, with 2 basal, mid-, and apical segments in each view, of which 2 segments are shared in the standard apical 4- and 3-chamber views (i.e., a total of 16 segments in the 3 views). The 17th segment at the apex will not be scored since it does not connect to any part of the LV endocardial border. For each segment, LVEBD is graded as follows: 0 = inadequate border (border not visible); 1 = sufficient (border barely visible); 2 = good (border clearly visible). A total delineation score (0 to 32) is obtained by adding the scores from a total of the 16 segments in the 3 views.
Time frame: Image data obtained pre-injection and within 10 minutes post-injection
Left Ventricular Opacification (LVO)
The co-primary endpoint will be the proportion of subjects with adequate LVO defined by an LVO grade of +2 (moderate) or +3 (complete), as assessed through blinded central reading.
Time frame: Image data obtained pre-injection and within 10 minutes post-injection
The number and percentage of subjects with suboptimal echocardiography converted into optimal echocardiography
Objective evaluation of the number and percentage of subjects with suboptimal echocardiography (based on the definition of inadequate LVEBD; i.e., at least two segments \[combined chamber view\] with an LVEBD score of 0) converted into optimal echocardiography following administration of study drug will be summarized for each reader.
Time frame: Image data obtained pre-injection and within 10 minutes post-injection
Standard 12-lead ECG QT interval
Standard 12-lead ECG QT interval assessed prior to injection and at 10 and 30 minutes after the end of injection; and at 24 hours after the end of injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Taipei Veterans General Hospital
Taipei, Taiwan
National Taiwan University Hospital Hsin-Chu Branch
Zhubei, Taiwan
Time frame: From pre-injection to 24 hours post injection
Blood Pressure (BP)
Changes in BP assessed prior to injection and at 5, 10, and 30 minutes the end of after injection; and at 24 hours after the end of injection
Time frame: From pre-injection to 24 hours post injection
Heart Rate (HR)
Changes in HR assessed prior to injection and at 5, 10, and 30 minutes the end of after injection; and at 24 hours after the end of injection
Time frame: From pre-injection to 24 hours post injection
SpO2
SpO2 assessed by pulse oximetry prior to injection and at 5, 10, and 30 minutes after the end of injection; and at 24 hours after the end of injection
Time frame: From pre-injection to 24 hours post injection