Heart ultrasound gets a boost: new contrast agent aims for sharper images

NCT ID NCT06815627

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether NH002, a contrast agent made of tiny gas-filled microspheres, can improve the quality of heart ultrasound images in people with heart disease. Participants receive NH002 through an IV before a standard echocardiogram. The study compares the clarity of heart chamber borders and overall image quality with and without the contrast agent. The goal is to see if NH002 helps doctors get clearer, more reliable images of the heart.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NH002 (Perflutren Lipid Microspheres) Injectable Suspension
What this could lead to
If successful, NH002 could make heart ultrasounds more accurate, helping doctors see heart structure and function better without more invasive tests.
What could go wrong
This is a Phase 3 trial with 150 participants, so results may not apply to everyone. The contrast agent may cause side effects like allergic reactions or temporary discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 years of age or older 2. Ability to understand and the willingness to provide written informed consent 3. Having or suspected of having cardiac disease 4. 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: Subjects will be excluded from the study if one or more of the following exclusion criteria are applicable: 1. 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: 1. ongoing or recent acute coronary syndrome within 6 months. 2. uncontrolled serious ventricular arrhythmias. 3. decompensated or inadequately controlled congestive heart failure (New York Heart Association Class IV). 4. atrial fibrillation or current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise. 5. uncontrolled hypertension (i.e., resting systolic blood pressure \>200 mmHg or diastolic blood pressure \>110 mmHg or arterial hypotension \[defined as systolic blood pressure ≤ 90 mmHg\]). 6. acute aortic dissection. 2. Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, Definity®, or other echocardiographic contrast agents 3. 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) 4. Received an investigational compound within 30 days before enrolling in the study 5. Received any contrast agent either intravascularly or orally within 48 hours prior to NH002 dose administration 6. Pregnant or lactating female. Exclude the possibility of pregnancy: 1. 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 2. 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 3. surgical history (e.g., tubal ligation or hysterectomy), or 4. postmenopausal with a minimum of 1 year without menses. 7. Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cathay General Hospital

    Taipei, 106438, Taiwan

  • China Medical University Hospital

    Taichung, 404327, Taiwan

  • Keelung Chang Gung Memorial Hospital & Lovers Lake Branch

    Keelung, 204201, Taiwan

  • MacKay Memorial Hospital

    Taipei, 104217, Taiwan

  • National Taiwan University Hospital Hsin-Chu Branch

    Zhubei, 302058, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

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