Cardiac DiseasesPhase 3NCT07740421
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
A Phase 3 study testing NH002 (Perflutren Lipid Microspheres) Injectable Suspension in people with Cardiac Diseases, run by Trust Bio-sonics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Diseases
- What is being tested?
- NH002 (Perflutren Lipid Microspheres) Injectable Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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])
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- 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
About this study
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
- Being tested
- NH002 (Perflutren Lipid Microspheres) Injectable Suspension
- Keywords
- Echo, Echocardiogram, Cardiac ultrasound, Suboptimal, Contrast agent, Enhancing agent, LVO, LVEBD
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NH002 (Perflutren Lipid Microspheres) Injectable SuspensionDrug
NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | 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. Receives: Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension |
| Sequence 2 | Experimental | 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. Receives: Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Endocardial Border Delineation (LVEBD)
The first primary efficacy endpoint will be the change from baseline (prior to each dose of NH002 administration) in total LVEBD scores (UEUS vs CEUS) defined using a 16-segment model derived from the standard 17-segment model, as assessed through blinded central reading. The LV endocardium of the standard apical 4-, 2-, and 3-chamber views is divided into 6 segments, with 2 basal, mid-, and apical segments in each view, of which 2 segments are shared in the standard apical 4- and 3-chamber views (i.e., a total of 16 segments in the 3 views). The 17th segment at the apex will not be scored since it does not connect to any part of the LV endocardial border. For each segment, LVEBD is graded as follows: 0 = inadequate border (border not visible); 1 = sufficient (border barely visible); 2 = good (border clearly visible). A total delineation score (0 to 32) is obtained by adding the scores from a total of the 16 segments in the 3 views.
Measured: Image data obtained pre-injection and within 15 minutes post-injection
Left Ventricular Opacification (LVO)
The co-primary endpoint will be the proportion of subjects with adequate LVO defined by an LVO grade of +2 (moderate) or +3 (complete), as assessed through blinded central reading.
Measured: Image data obtained pre-injection and within 15 minutes post-injection
Secondary outcomes (7)
The number and percentage of subjects with suboptimal echocardiography converted into optimal echocardiography
Objective evaluation of the number and percentage of subjects with suboptimal echocardiography (based on the definition of inadequate LVEBD, i.e., at least two segments [in any chamber view] with an LVEBD score of 0) converted into optimal echocardiography following administration of study drug will be summarized for each reader.
Measured: Image data obtained pre-injection and within 15 minutes post-injection
Standard 12-lead ECGs
Standard 12-lead ECGs assessed prior to injection and at 10 and 30 minutes after the initiation of IV bolus injection and infusion; and at 24 hours after the end of the second dose of NH002
Measured: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
Blood Pressure (BP)
Change in BP assessed prior to injection and at 5, 10 and 30 minutes after the initiation of IV bolus injection and infusion; and at 24 hours after the end of the second dose of NH002
Measured: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
Heart Rate (HR)
Change in HR assessed prior to injection and at 5, 10 and 30 minutes after the initiation of IV bolus injection and infusion; and at 24 hours after the end of the second dose of NH002
Measured: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
SpO2
SpO2 assessed by pulse oximetry prior to injection and at 5, 10 and 30 minutes after the initiation of IV bolus injection and infusion; and at 24 hours after the end of the second dose of NH002
Measured: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
Physical Examination (PE)
PE assessed prior to injection and at 30 minutes after the initiation of IV bolus injection and infusion; and at 24 hours after the end of the second dose of NH002
Measured: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
Adverse Events (AEs)
AEs assessed prior to injection and at 5, 10, 15 and 30 minutes after the initiation of IV bolus injection and infusion; and at 24 hours after the end of the second dose of NH002
Measured: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trust Bio-sonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740421
- Sponsor's protocol ID
- NH002-LV-03
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07740421
- Acronym / sponsor ID
- NH002-LV-03
- Conditions
- Cardiac Diseases
- Keywords
- Echo, Echocardiogram, Cardiac ultrasound, Suboptimal, Contrast agent, Enhancing agent, LVO, LVEBD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Trust Bio-sonics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: NH002 (Perflutren Lipid Microspheres) Injectable SuspensionSubjects 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. |
| Sequence 2 | Experimental | Drug: NH002 (Perflutren Lipid Microspheres) Injectable SuspensionSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NH002 (Perflutren Lipid Microspheres) Injectable SuspensionNH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use. | Drug | Sequence 1, Sequence 2 |
Primary outcome
Left Ventricular Endocardial Border Delineation (LVEBD)
Time frame: Image data obtained pre-injection and within 15 minutes post-injection
The first primary efficacy endpoint will be the change from baseline (prior to each dose of NH002 administration) in total LVEBD scores (UEUS vs CEUS) defined using a 16-segment model derived from the standard 17-segment model, as assessed through blinded central reading. The LV endocardium of the standard apical 4-, 2-, and 3-chamber views is divided into 6 segments, with 2 basal, mid-, and apical segments in each view, of which 2 segments are shared in the standard apical 4- and 3-chamber views (i.e., a total of 16 segments in the 3 views). The 17th segment at the apex will not be scored since it does not connect to any part of the LV endocardial border. For each segment, LVEBD is graded as follows: 0 = inadequate border (border not visible); 1 = sufficient (border barely visible); 2 = good (border clearly visible). A total delineation score (0 to 32) is obtained by adding the scores from a total of the 16 segments in the 3 views.
Left Ventricular Opacification (LVO)
Time frame: Image data obtained pre-injection and within 15 minutes post-injection
The co-primary endpoint will be the proportion of subjects with adequate LVO defined by an LVO grade of +2 (moderate) or +3 (complete), as assessed through blinded central reading.
7 secondary outcomes
The number and percentage of subjects with suboptimal echocardiography converted into optimal echocardiography
Time frame: Image data obtained pre-injection and within 15 minutes post-injection
Standard 12-lead ECGs
Time frame: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
Blood Pressure (BP)
Time frame: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
Heart Rate (HR)
Time frame: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
SpO2
Time frame: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
Physical Examination (PE)
Time frame: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
Adverse Events (AEs)
Time frame: From pre-injection (before the first dose) to 24 hours (after the end of second dose)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NH002 (Perflutren Lipid Microspheres) Injectable Suspension in people with Cardiac Diseases, run by Trust Bio-sonics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Endocardial Border Delineation (LVEBD) (time frame: Image data obtained pre-injection and within 15 minutes post-injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.