This is a phase III, prospective, multicenter, open-label, crossover study of the safety and efficacy of NH002-enhanced echocardiography in adult subjects with suboptimal images on non-contrast 2D transthoracic echocardiography with harmonic imaging within 30 days ahead of NH002 administration. The efficacy for two different modes of administration (i.e., IV bolus injection and infusion) will be evaluated independently.
18 years of age or older
Ability to understand and the willingness to provide written informed consent
Having or suspected of having cardiac disease
Undergone a transthoracic echo within 30 days prior to NH002 dose administration, resulting in suboptimal LVEBD, as defined by 2 or more segments of 6 segments of the ventricular border that cannot be visualized reliably in any of the standard apical 4-, 2-, and 3-chamber views during the resting non-contrast ultrasound examination
ongoing or recent acute coronary syndrome within 6 months
uncontrolled serious ventricular arrhythmias
decompensated or inadequately controlled congestive heart failure (New York Heart Association Class IV)
atrial fibrillation or current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
Crossover
NH002 (Perflutren Lipid Microspheres) Injectable Suspension
DrugNH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.
Left Ventricular Endocardial Border Delineation (LVEBD)
The first primary efficacy endpoint will be the change from baseline (prior to each dose of NH002 administration) 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.
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.
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 \[in any chamber view\] with an LVEBD score of 0) converted into optimal echocardiography following administration of study drug will be summarized for each reader.
Standard 12-lead ECGs
Standard 12-lead ECGs assessed prior to injection and at 10 and 30 minutes after the initiation of IV bolus injection and infusion; and at 24 hours after the end of the second dose of NH002
Blood Pressure (BP)
Change in BP assessed prior to injection and at 5, 10 and 30 minutes after the initiation of IV bolus injection and infusion; and at 24 hours after the end of the second dose of NH002
Heart Rate (HR)
Change in HR assessed prior to injection and at 5, 10 and 30 minutes after the initiation of IV bolus injection and infusion; and at 24 hours after the end of the second dose of NH002
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Trust Bio-sonics, Inc.
Lead sponsor
Syneos Health
Collaborator
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