A Prospective, Multicenter, Phase III Clinical Evaluation of the Safety and Efficacy of NH002 as a Contrast Agent Administrated Via Intravenous Bolus Injection and Infusion for Subjects Undergoing Cardiac Echocardiography

NCT07740421 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: NH002-LV-03
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiac Diseases

Keywords

Echo; Echocardiogram; Cardiac ultrasound; Suboptimal; Contrast agent; Enhancing agent; LVO; LVEBD

Outcome Measures

Primary Outcomes (2)

• 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.

  Image data obtained pre-injection and within 15 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.

  Image data obtained pre-injection and within 15 minutes post-injection

Secondary Outcomes (7)

• The number and percentage of subjects with suboptimal echocardiography converted into optimal echocardiography

  Image data obtained pre-injection and within 15 minutes post-injection

• Standard 12-lead ECGs

  From pre-injection (before the first dose) to 24 hours (after the end of second dose)

• Blood Pressure (BP)

  From pre-injection (before the first dose) to 24 hours (after the end of second dose)

• Heart Rate (HR)

  From pre-injection (before the first dose) to 24 hours (after the end of second dose)

• SpO2

  From pre-injection (before the first dose) to 24 hours (after the end of second dose)

Study Arms (2)

Sequence 1

EXPERIMENTAL

Subjects who are enrolled in the study will undergo two-time resting unenhanced ultrasound examination (shortly before each dose of NH002 administration) and two-time NH002 contrast-enhanced examination on the same day at Day 1 (with the first administration via bolus injection and the second via infusion), with the standard apical 4-, 2-, and 3-chamber views obtained with B-mode and contrast-specific imaging, respectively.

Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension

Sequence 2

EXPERIMENTAL

Subjects who are enrolled in the study will undergo two-time resting unenhanced ultrasound examination (shortly before each dose of NH002 administration) and two-time NH002 contrast-enhanced examination on the same day at Day 1 (with the first administration via infusion and the second via bolus injection), with the standard apical 4-, 2-, and 3-chamber views obtained with B-mode and contrast-specific imaging, respectively.

Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension

Interventions

NH002 (Perflutren Lipid Microspheres) Injectable Suspension DRUG

NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any evidence of other severe or unstable cardiopulmonary and/or systemic hemodynamic conditions deemed unsuitable for the study by the investigator(s) prior to NH002 dose administration, including, but not limited to:
• 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
• uncontrolled hypertension (i.e., resting systolic blood pressure \>200 mmHg, diastolic blood pressure \>110 mmHg, or arterial hypotension \[defined as systolic blood pressure ≤ 90 mmHg\])
• acute aortic dissection
• Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, Definity, or other echocardiographic contrast agents
• Known or suspected hypersensitivity to PEG, prior reactions to common PEG-containing products such as colonoscopy bowel preparations, and certain laxatives (e.g., Miralax)
• Received an investigational compound within 30 days before enrolling in the study
• Received any contrast agent either intravascularly or orally within 48 hours prior to NH002 dose administration
• Pregnant or lactating female. Exclude the possibility of pregnancy:
• testing on-site at the institution (serum or urine β-human chorionic gonadotropin) within 7 days prior to the start of NH002 dose administration, and
• history of using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to NH002 dose administration and willing to continue using the same method for the duration of the study, or
• surgical history (e.g., tubal ligation or hysterectomy), or

Sponsors & Collaborators

• Trust Bio-sonics, Inc.: lead
• Syneos Health: collaborator

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share