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

Last updated: August 19, 2025
Sponsor: Trust Bio-sonics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

NH002 (Perflutren Lipid Microspheres) Injectable Suspension

Clinical Study ID

NCT06815627
NH002-LV-02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theventricular 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

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 hemodynamicconditions deemed unsuitable for the study by the investigator(s) prior to NH002dose administration, including, but not limited to:

  2. ongoing or recent acute coronary syndrome within 6 months.

  3. uncontrolled serious ventricular arrhythmias.

  4. decompensated or inadequately controlled congestive heart failure (New YorkHeart Association Class IV).

  5. atrial fibrillation or current uncontrolled cardiac arrhythmias causingsymptoms or hemodynamic compromise.

  6. uncontrolled hypertension (i.e., resting systolic blood pressure >200 mmHg ordiastolic blood pressure >110 mmHg or arterial hypotension [defined as systolicblood pressure ≤ 90 mmHg]).

  7. acute aortic dissection.

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

  9. Known or suspected hypersensitivity to polyethylene glycol, prior reactions tocommon polyethylene glycol-containing products such as colonoscopy bowelpreparations, and certain laxatives (e.g., Miralax)

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

  11. Received any contrast agent either intravascularly or orally within 48 hours priorto NH002 dose administration

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

  13. testing on-site at the institution (serum or urine β-human chorionicgonadotropin) within 24 hours prior to the start of NH002 dose administration,and

  14. history of using an adequate and medically approved method of contraception toavoid pregnancy for at least 1 month prior to NH002 dose administration andwilling to continue using the same method for the duration of the study, or

  15. surgical history (e.g., tubal ligation or hysterectomy), or

  16. postmenopausal with a minimum of 1 year without menses.

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

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: NH002 (Perflutren Lipid Microspheres) Injectable Suspension
Phase: 3
Study Start date:
March 18, 2025
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Keelung Chang Gung Memorial Hospital & Lovers Lake Branch

    Keelung, 204201
    Taiwan

    Site Not Available

  • Keelung Chang Gung Memorial Hospital & Lovers Lake Branch

    Keelung 1678228, 204201
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    Taichung, 404327
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung 1668399, 404327
    Taiwan

    Active - Recruiting

  • Cathay General Hospital

    Taipei, 106438
    Taiwan

    Site Not Available

  • MacKay Memorial Hospital

    Taipei, 104217
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Cathay General Hospital

    Taipei 1668341, 106438
    Taiwan

    Active - Recruiting

  • MacKay Memorial Hospital

    Taipei 1668341, 104217
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei 1668341, 11217
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital Hsin-Chu Branch

    Zhubei, 302058
    Taiwan

    Site Not Available

  • National Taiwan University Hospital Hsin-Chu Branch

    Zhubei 1677112, 302058
    Taiwan

    Active - Recruiting

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