A Prospective, Multicenter, Phase III Clinical Evaluation of the Safety and Efficacy of NH002 as a Contrast Agent Administrated Via Intravenous... | NCT07740421

NCT07740421

Overview

NCT ID: NCT07740421
Lead Sponsor: Trust Bio-sonics, Inc.INDUSTRY
Official Title: 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
Brief Summary: 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.
Conditions: Cardiac Diseases
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Jul 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Phase 3
Enrollment: 150Estimated
Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Similar Studies

Participant Group/Arms

Sequence 1Experimental

Subjects who are enrolled in the study will undergo two-time resting unenhanced ultrasound examination (shortly before each dose of NH002 administration) and two-time NH002 contrast-enhanced examination on the same day at Day 1 (with the first administration via bolus injection and the second via infusion), with the standard apical 4-, 2-, and 3-chamber views obtained with B-mode and contrast-specific imaging, respectively.

Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension

Sequence 2Experimental

Subjects who are enrolled in the study will undergo two-time resting unenhanced ultrasound examination (shortly before each dose of NH002 administration) and two-time NH002 contrast-enhanced examination on the same day at Day 1 (with the first administration via infusion and the second via bolus injection), with the standard apical 4-, 2-, and 3-chamber views obtained with B-mode and contrast-specific imaging, respectively.

Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension