Heart ultrasound gets a boost: new contrast agent aims for sharper images
NCT ID NCT06815627
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Cathay General Hospital
Taipei, 106438, Taiwan
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China Medical University Hospital
Taichung, 404327, Taiwan
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Keelung Chang Gung Memorial Hospital & Lovers Lake Branch
Keelung, 204201, Taiwan
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MacKay Memorial Hospital
Taipei, 104217, Taiwan
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National Taiwan University Hospital Hsin-Chu Branch
Zhubei, 302058, Taiwan
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Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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