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Cardiac DiseasesPhase 3NCT06815627

Safety and Efficacy Evaluation of NH002 as a Contrast Agent in 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. at 6 sites in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase 3, prospective, open-label, multicenter study to assess the efficacy of NH002-enhanced echocardiography in subjects with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the left ventricular endocardial border delineation compared with unenhanced echocardiography. 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
6 sitesTaiwan
Study dates
18 Mar 2025to Feb 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

  • Subjects will be excluded from the study if one or more of the following exclusion criteria are applicable:
  • 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.
Show all 18Show fewer
  • 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]).
  • 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 polyethylene glycol, prior reactions to common polyethylene glycol-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 24 hours 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 to protocol treatment/research

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Taiwan6 sites

  • Keelung Chang Gung Memorial Hospital & Lovers Lake Branch

    Keelung, 204201

  • China Medical University Hospital

    Taichung, 404327

  • MacKay Memorial Hospital

    Taipei, 104217

  • Cathay General Hospital

    Taipei, 106438

  • Taipei Veterans General Hospital

    Taipei, 11217

  • National Taiwan University Hospital Hsin-Chu Branch

    Zhubei, 302058

Other trials in Taiwan

About this study

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

This is a Phase 3, prospective, open-label, multicenter study to assess the efficacy of NH002-enhanced echocardiography in subjects with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the left ventricular endocardial border delineation compared with unenhanced echocardiography. The study also aims to investigate the safety and tolerability of NH002.

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 groups in NCT06815627
Study groupRoleWhat they receive
NH002ExperimentalSubjects 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.
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.

  1. Left Ventricular Endocardial Border Delineation (LVEBD)

    The first primary efficacy endpoint will be the change from baseline 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 10 minutes post-injection

  2. 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 10 minutes post-injection

Secondary outcomes (5)

  1. 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 [combined 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 10 minutes post-injection

  2. Standard 12-lead ECG QT interval

    Standard 12-lead ECG QT interval assessed prior to injection and at 10 and 30 minutes after the end of injection; and at 24 hours after the end of injection

    Measured: From pre-injection to 24 hours post injection

  3. Blood Pressure (BP)

    Changes in BP assessed prior to injection and at 5, 10, and 30 minutes the end of after injection; and at 24 hours after the end of injection

    Measured: From pre-injection to 24 hours post injection

  4. Heart Rate (HR)

    Changes in HR assessed prior to injection and at 5, 10, and 30 minutes the end of after injection; and at 24 hours after the end of injection

    Measured: From pre-injection to 24 hours post injection

  5. SpO2

    SpO2 assessed by pulse oximetry prior to injection and at 5, 10, and 30 minutes after the end of injection; and at 24 hours after the end of injection

    Measured: From pre-injection to 24 hours post injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2025
  2. Study start18 Mar 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06815627
Sponsor's protocol ID
NH002-LV-02
Status last verified
Jul 2026
First submitted
21 Jan 2025
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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. at 6 sites in Taiwan.

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 18 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 10 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?

On the ClinicalTrials.gov record for NCT06815627.

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 9 Jul 2026.

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