A Prospective, Multicenter, Phase III Clinical Evaluation of the Safety and Efficacy of NH002 as a Contrast Agent Administrated Via Intravenous Bolus Injection and Infusion for Subjects Undergoing Cardiac Echocardiography

Обзор

This is a phase III, prospective, multicenter, open-label, crossover study of the safety and efficacy of NH002-enhanced echocardiography in adult subjects with suboptimal images on non-contrast 2D transthoracic echocardiography with harmonic imaging within 30 days ahead of NH002 administration. The efficacy for two different modes of administration (i.e., IV bolus injection and infusion) will be evaluated independently.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Left Ventricular Endocardial Border Delineation (LVEBD) [Срок оценки: Image data obtained pre-injection and within 15 minutes post-injection]
• Left Ventricular Opacification (LVO) [Срок оценки: Image data obtained pre-injection and within 15 minutes post-injection]

Вторичные конечные точки (7)

• The number and percentage of subjects with suboptimal echocardiography converted into optimal echocardiography [Срок оценки: Image data obtained pre-injection and within 15 minutes post-injection]
• Standard 12-lead ECGs [Срок оценки: From pre-injection (before the first dose) to 24 hours (after the end of second dose)]
• Blood Pressure (BP) [Срок оценки: From pre-injection (before the first dose) to 24 hours (after the end of second dose)]
• Heart Rate (HR) [Срок оценки: From pre-injection (before the first dose) to 24 hours (after the end of second dose)]
• SpO2 [Срок оценки: From pre-injection (before the first dose) to 24 hours (after the end of second dose)]
• Physical Examination (PE) [Срок оценки: From pre-injection (before the first dose) to 24 hours (after the end of second dose)]
• Adverse Events (AEs) [Срок оценки: From pre-injection (before the first dose) to 24 hours (after the end of second dose)]

Критерии участия

Критерии включения

• 18 years of age or older
• Ability to understand and the willingness to provide written informed consent
• Having or suspected of having cardiac disease
• 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

Критерии исключения

• 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:

• ongoing or recent acute coronary syndrome within 6 months
• uncontrolled serious ventricular arrhythmias
• decompensated or inadequately controlled congestive heart failure (New York Heart Association Class IV)
• atrial fibrillation or current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
• uncontrolled hypertension (i.e., resting systolic blood pressure >200 mmHg, diastolic blood pressure >110 mmHg, or arterial hypotension \[defined as systolic blood pressure ≤ 90 mmHg\])
• acute aortic dissection
• Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, Definity, or other echocardiographic contrast agents
• Known or suspected hypersensitivity to PEG, prior reactions to common PEG-containing products such as colonoscopy bowel preparations, and certain laxatives (e.g., Miralax)
• Received an investigational compound within 30 days before enrolling in the study
• Received any contrast agent either intravascularly or orally within 48 hours prior to NH002 dose administration
• Pregnant or lactating female. Exclude the possibility of pregnancy:

• testing on-site at the institution (serum or urine β-human chorionic gonadotropin) within 7 days prior to the start of NH002 dose administration, and
• 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
• surgical history (e.g., tubal ligation or hysterectomy), or
• postmenopausal with a minimum of 1 year without menses.
• Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance with protocol treatment/research

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07740421 · NH002-LV-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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