Can tiny bubbles make heart scans crystal clear?
NCT ID NCT07740421
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 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: 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cardiac diseases are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
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.
-
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.
- Can community hospitals in zambia master severe disease care?
- Massive heart biobank aims to unlock genetic secrets of cardiovascular disease
- Heart ultrasound gets a boost: new contrast agent aims for sharper images
- New heart MRI could slash scan time and hassle
- Can a simple exercise test tell ME/CFS apart from heart disease?
- No more fasting before heart catheterization? trial challenges standard practice