New heart ultrasound dye passes early safety tests
NCT ID NCT04185246
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new contrast agent called NH002 in 36 adults with heart disease. The agent is used during heart ultrasound to make the heart's chambers and borders clearer. The main goal was to check safety by monitoring vital signs, heart activity, and allergic reactions after three different doses.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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36 people
The number who actually took part.
- Started
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Nov 2019
- Finished
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Jul 2020
- 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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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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. Male or female subjects 20 years of age or older 2. Ability to understand and the willingness to provide written informed consent 3. Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease 4. Negative pregnancy test within 24 hours of the procedure if subject is a woman of childbearing potential Exclusion Criteria: 1. Known right-to-left, bidirectional, or transient right-to-left cardiac shunt(s) 2. Chronic obstructive pulmonary disease 3. Ejection fraction at screening or baseline \<40% 4. 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) 5. Clinically significant abnormality in renal and liver function tests (alanine aminotransferase/aspartate aminotransferase \>2 × upper limit of normal \[ULN\]; serum creatinine \> 1.5 × ULN) 6. Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, or other echocardiographic contrast agent 7. Received an investigational compound within 30 days before enrolling in the study 8. Received any contrast agent either intravascularly or orally within 48 hours before NH002 administration 9. Pregnant or lactating female (conception during the study should be avoided) 10. Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research 11. Clinically unstable cardiopulmonary conditions considered not suitable for participation in the trial, in the judgment of the investigator 12. 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)
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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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Taipei Mackay Memorial Hospital
Taipei, 10449, Taiwan
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Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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Other studies related to the condition(s) this trial covers.
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