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A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography

A Multicenter, Open-Label, Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography

NCT04185246•Trust Bio-sonics, Inc.

View on ClinicalTrials.gov

Summary

NH002 (Perflutren Lipid Microspheres) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular (LV) chamber and to improve the delineation of the LV endocardial border. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of NH002.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+2 more criteria

Locations (2)

Taipei Mackay Memorial Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Key Dates

Start Date

November 4, 2019

Primary Completion Date

July 1, 2020

Completion Date

July 1, 2020

Last Updated

November 18, 2025

Enrollment

ACTUAL participants

Conditions

Cardiac Disease

Interventions

NH002 (Perflutren Lipid Microspheres) Injectable Suspension

DRUG

Echocardiogram

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography

Inclusion Criteria

Exclusion Criteria

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