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

August 19, 2025 updated by: Trust Bio-sonics, Inc.

A Prospective, Multicenter, Phase III Clinical Evaluation of the Safety and Efficacy of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Keelung, Taiwan, 204201
        • Recruiting
        • Keelung Chang Gung Memorial Hospital & Lovers Lake Branch
        • Contact:
      • Taichung, Taiwan, 404327
        • Recruiting
        • China Medical University Hospital
        • Contact:
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taipei, Taiwan, 104217
        • Recruiting
        • Mackay Memorial Hospital
        • Contact:
      • Taipei, Taiwan, 106438
        • Recruiting
        • Cathay General Hospital
        • Contact:
      • Zhubei, Taiwan, 302058
        • Recruiting
        • National Taiwan University Hospital Hsin-Chu Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NH002
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.
Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension
NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Ventricular Endocardial Border Delineation (LVEBD)
Time Frame: 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.
Image data obtained pre-injection and within 10 minutes post-injection
Left Ventricular Opacification (LVO)
Time Frame: 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.
Image data obtained pre-injection and within 10 minutes post-injection

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trust Bio-sonics, Inc.

Collaborators

CMIC ASIA-PACIFIC, PTE. LTD., TAIWAN BRANCH

Investigators

  • Principal Investigator: Wen-Chung Yu, Taipei Veterans General Hospital, Taiwan
  • Principal Investigator: Chung-Lieh Hung, Mackay Memorial Hospital
  • Principal Investigator: Chih-Hui Chin, Cathay General Hospital
  • Principal Investigator: Hsin-Yueh Liang, China Medical University Hospital
  • Principal Investigator: Ning-I Yang, Chang Gung Memorial Hospital
  • Principal Investigator: Chien-Boon Jong, National Taiwan University Hospital Hsin-Chu Branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NH002-LV-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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