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Cardiac DiseasePhase 1/2NCT04185246

A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography

A Phase 1/2 study testing NH002 (Perflutren Lipid Microspheres) Injectable Suspension and Echocardiogram in people with Cardiac Disease, run by Trust Bio-sonics, Inc. at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

NH002 (Perflutren Lipid Microspheres) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular (LV) chamber and to improve the delineation of the LV endocardial border. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiac Disease
What is being tested?
NH002 (Perflutren Lipid Microspheres) Injectable Suspension and Echocardiogram
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesTaiwan
Study dates
4 Nov 2019to 1 Jul 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female subjects 20 years of age or older
  • Ability to understand and the willingness to provide written informed consent
  • Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease
  • Negative pregnancy test within 24 hours of the procedure if subject is a woman of childbearing potential

Who cannot join

  • Known right-to-left, bidirectional, or transient right-to-left cardiac shunt(s)
  • Chronic obstructive pulmonary disease
  • Ejection fraction at screening or baseline <40%
  • Uncontrolled serious ventricular arrhythmias or at high risk for arrhythmias due to prolongation of the QT interval (QT corrected by Fridericia's formula >450 msec in males and >470 msec in females)
  • Clinically significant abnormality in renal and liver function tests (alanine aminotransferase/aspartate aminotransferase >2 × upper limit of normal [ULN]; serum creatinine > 1.5 × ULN)
  • Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, or other echocardiographic contrast agent
Show all 12Show fewer
  • Received an investigational compound within 30 days before enrolling in the study
  • Received any contrast agent either intravascularly or orally within 48 hours before NH002 administration
  • Pregnant or lactating female (conception during the study should be avoided)
  • Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research
  • Clinically unstable cardiopulmonary conditions considered not suitable for participation in the trial, in the judgment of the investigator
  • Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg)

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Taipei Mackay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Multicenter, Open-Label, Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography

NH002 (Perflutren Lipid Microspheres) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular (LV) chamber and to improve the delineation of the LV endocardial border. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of NH002.

Conditions
Cardiac Disease
Being tested
NH002 (Perflutren Lipid Microspheres) Injectable Suspension, Echocardiogram
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.

  • EchocardiogramDiagnostic test

    Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day.

Study groups in NCT04185246
Study groupRoleWhat they receive
Single armExperimentalSubjects will be enrolled with sequential allocation to 1 of 3 cohorts with the following intravenous (IV) doses of NH002: 2.5 µl/kg, 5.0 µl/kg, or 10.0 µl/kg. Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day
Receives: Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension; Diagnostic Test: Echocardiogram

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12-lead ECGs

    Standard 12-lead ECGs will be assessed from pre-injection to 60 minutes post-injection for changes in QT/ corrected QT(QTc) interval (in ms) and ECG morphology; each standard 12-lead ECG assessment will be scored as either normal or abnormal

    Measured: From pre-injection to 60 minutes post injection

  2. Body Temperature

    Monitor for any changes in body temperature (in Celsius degree)

    Measured: From pre-injection to 120 minutes post injection

  3. Heart Rate

    Monitor for any changes in heart rate (in beats/min)

    Measured: From pre-injection to 120 minutes post injection

  4. Respiratory Rate

    Monitor for any changes in respiratory rate (in breaths/min)

    Measured: From pre-injection to 120 minutes post injection

  5. Blood Pressure

    Monitor for any changes in blood pressure (in mmHg)

    Measured: From pre-injection to 120 minutes post injection

  6. Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)

    Monitor for any changes in TT and aPTT

    Measured: From pre-injection to 240 minutes post-injection

  7. Cardiac Troponin I

    Monitor for any changes in Cardiac troponin I

    Measured: pre-injection and 240 minutes post-injection

  8. Oxygen Saturation by Pulse Oximetry (SpO2)

    Monitor for any changes in SpO2

    Measured: From pre-injection to 120 minutes post-injection

  9. Rate of Any Potential Adverse Allergic Reaction

    Monitor for any potential adverse allergic reaction

    Measured: From pre-injection to 240 minutes post-injection

  10. Cardiac Troponin T

    Monitor for any changes in Cardiac troponin T

    Measured: pre-injection and 240 minutes post-injection

Secondary outcomes (3)

  1. Left Ventricular Opacification (LVO)

    The percentage of subjects with moderate or complete left ventricular opacification (LVO), defined by an LVO grade of 2 (moderate) or 3 (complete), as assessed by the blinded central reader(s).

    The percentage of subjects with complete LVO, defined by an LVO grade of 3 (complete), as assessed by the blinded central reader(s)

    Measured: Image data obtained pre-injection and within 10 minutes post-injection

  2. Left Ventricular Endocardial Border Delineation (LVEBD)

    The change from baseline on the left ventricular endocardial border delineation (LVEBD) score, defined using a standard 12-segment model, as assessed by the blinded central reader(s). The left ventricular (LV) endocardium of the 4- or 2- chamber apical views are divided into 6 segments, with 2 basal, mid- and apical segments in each view. 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 (0-24) is obtained by adding the scores from the 6 individual segments in each of the 2 views.

    The changes from baseline on LVEBD score of subjects with suboptimal LVEBD at baseline, as defined by 2 or more contiguous segments of 6 segments that cannot be visualized reliably in either the apical 4 and/or the 2-chamber view, as assessed by the blinded central reader(s)

    Measured: Image data obtained pre-injection and within 10 minutes post-injection

  3. Duration of Clinically Useful Contrast

    A duration of clinically useful contrast calculated by measuring the time between the disappearance of shadowing effect (useful effect starts) and the time when moderate or full LV enhancement and contrast enhancement are no longer adequate (useful effect ends), as assessed by the blinded central reader(s)

    Measured: Image data obtained pre-injection and within 10 minutes 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 posted4 Dec 2019
  2. Study start4 Nov 2019
  3. Primary completion1 Jul 2020
  4. Study completion1 Jul 2020

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 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04185246
Sponsor's protocol ID
NH002-LV
Status last verified
Nov 2025
First submitted
6 Nov 2019
Last updated
18 Nov 2025
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 1/2 study testing NH002 (Perflutren Lipid Microspheres) Injectable Suspension and Echocardiogram in people with Cardiac Disease, run by Trust Bio-sonics, Inc. at 2 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 12 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: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

12-lead ECGs (time frame: From pre-injection to 60 minutes post injection). The study lists 10 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 NCT04185246.

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 18 Nov 2025.

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