Safety and Efficacy Evaluation of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography

Phase 3

Recruiting

• Conditions: Cardiac Diseases
• Interventions: Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension

• Registration Number: NCT06815627
• Lead Sponsor: Trust Bio-sonics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-02-07
• Study Start: 2025-03-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. 18 years of age or older
2. Ability to understand and the willingness to provide written informed consent
3. Having or suspected of having cardiac disease
4. 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

Exclusion Criteria

Subjects will be excluded from the study if one or more of the following exclusion criteria are applicable:

1. 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:

   1. ongoing or recent acute coronary syndrome within 6 months.
   2. uncontrolled serious ventricular arrhythmias.
   3. decompensated or inadequately controlled congestive heart failure (New York Heart Association Class IV).
   4. atrial fibrillation or current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise.
   5. uncontrolled hypertension (i.e., resting systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg or arterial hypotension [defined as systolic blood pressure ≤ 90 mmHg]).
   6. acute aortic dissection.

2. Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, Definity®, or other echocardiographic contrast agents

3. Known or suspected hypersensitivity to polyethylene glycol, prior reactions to common polyethylene glycol-containing products such as colonoscopy bowel preparations, and certain laxatives (e.g., Miralax)

4. Received an investigational compound within 30 days before enrolling in the study

5. Received any contrast agent either intravascularly or orally within 48 hours prior to NH002 dose administration

6. Pregnant or lactating female. Exclude the possibility of pregnancy:

   1. testing on-site at the institution (serum or urine β-human chorionic gonadotropin) within 24 hours prior to the start of NH002 dose administration, and
   2. 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
   3. surgical history (e.g., tubal ligation or hysterectomy), or
   4. postmenopausal with a minimum of 1 year without menses.

7. Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NH002	NH002 (Perflutren Lipid Microspheres) Injectable Suspension	Subjects will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination (following intravenous (IV) doses of NH002: 2.5 µl/kg) on the same day.

Primary Outcome Measures

Name	Time	Method
Left Ventricular Endocardial Border Delineation (LVEBD)	Image data obtained pre-injection and within 10 minutes post-injection	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.
Left Ventricular Opacification (LVO)	Image data obtained pre-injection and within 10 minutes post-injection	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.

Secondary Outcome Measures

Name	Time	Method
The number and percentage of subjects with suboptimal echocardiography converted into optimal echocardiography	Image data obtained pre-injection and within 10 minutes post-injection	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.
Standard 12-lead ECG QT interval	From pre-injection to 24 hours post injection	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
Blood Pressure (BP)	From pre-injection to 24 hours post injection	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
Heart Rate (HR)	From pre-injection to 24 hours post injection	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
SpO2	From pre-injection to 24 hours post injection	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

Trial Locations

Locations (6)

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

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital Hsin-Chu Branch; 🇨🇳 Zhubei, Taiwan