Safety and Efficacy Evaluation of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography
NCT ID: NCT06815627
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2025-03-18
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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CMIC ASIA-PACIFIC, PTE. LTD., TAIWAN BRANCH
UNKNOWN
Trust Bio-sonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Wen-Chung Yu
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Chung-Lieh Hung
Role: PRINCIPAL_INVESTIGATOR
Mackay Memorial Hospital
Chih-Hui Chin
Role: PRINCIPAL_INVESTIGATOR
Cathay General Hospital
Hsin-Yueh Liang
Role: PRINCIPAL_INVESTIGATOR
China Medical University Hospital
Ning-I Yang
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Chien-Boon Jong
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital Hsin-Chu Branch
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NH002-LV-02
Identifier Type: -
Identifier Source: org_study_id
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