Evaluating NH002 as a contrast agent for cardiac echocardiography

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

This study is testing a new contrast agent called NH002 to see if it can improve heart ultrasound images for patients who didn't get clear results from standard tests.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Trust Bio-sonics, Inc. (Industry-sponsored)
• Locations: 6 sites (Keelung and 5 other locations)
• Trial ID: NCT06815627 on ClinicalTrials.gov

What this trial studies

This Phase 3, prospective, open-label, multicenter study aims to assess the efficacy of NH002, a contrast agent, in enhancing echocardiograms for patients with suboptimal imaging results. The study focuses on improving the visualization of the left ventricular chamber and endocardial borders compared to standard echocardiography without contrast. Additionally, it will evaluate the safety and tolerability of NH002 in these patients. Participants will receive NH002 after undergoing a transthoracic echo that did not provide clear imaging.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with suspected cardiac disease who have had a recent transthoracic echocardiogram showing suboptimal results.

Not a fit: Patients with severe or unstable cardiopulmonary conditions or recent acute coronary syndrome may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the accuracy of cardiac assessments in patients with suboptimal echocardiograms.

How similar studies have performed: Other studies have explored the use of contrast agents in echocardiography, showing promising results, but this specific approach with NH002 is relatively novel.

Eligibility criteria

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

Where this trial is running

Keelung and 5 other locations

• Keelung Chang Gung Memorial Hospital & Lovers Lake Branch — Keelung, Taiwan (Recruiting)
• China Medical University Hospital — Taichung, Taiwan (Recruiting)
• MacKay Memorial Hospital — Taipei, Taiwan (Recruiting)
• Cathay General Hospital — Taipei, Taiwan (Recruiting)
• Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
• National Taiwan University Hospital Hsin-Chu Branch — Zhubei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Wen-Chung Yu — Taipei Veterans General Hospital, Taiwan
• Study coordinator: Shih-Tsung Kang, Ph.D

Conditions Cardiac Diseases; Echo; Echocardiogram; Cardiac ultrasound; suboptimal; contrast agent; enhancing agent; LVO