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New heart ultrasound dye passes early safety tests

NCT ID NCT04185246

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

36 people

The number who actually took part.

Started

Nov 2019

Finished

Jul 2020

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

20 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. 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

  • Taipei Mackay Memorial Hospital

    Taipei, 10449, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

More trials for these conditions

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