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Can tiny bubbles make heart scans crystal clear?

NCT ID NCT07740421

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether an experimental contrast agent called NH002 can improve the quality of heart ultrasound images in adults with suspected or known heart disease. The agent is given as an injection or infusion and contains tiny microbubbles that help outline the heart's inner chambers. Researchers will compare images taken with and without the contrast to see if it makes the heart's borders easier to see, which could help doctors diagnose heart conditions more accurately.

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), an injectable microbubble contrast agent
What this could lead to
If successful, NH002 could become a standard contrast agent to improve heart ultrasound clarity, helping doctors see heart chambers better without more invasive tests.
What could go wrong
This is a phase III trial, but results may not confirm benefit or safety in all patients. Contrast agents carry risks like allergic reactions or rare serious side effects.

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.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 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: 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, 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 PEG, prior reactions to common PEG-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 7 days 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 with 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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.