Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06815627

Safety and Efficacy Evaluation of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography

Led by Trust Bio-sonics, Inc. · Updated on 2025-08-26

150

Participants Needed

6

Research Sites

97 weeks

Total Duration

On this page

Sponsors

T

Trust Bio-sonics, Inc.

Lead Sponsor

C

CMIC ASIA-PACIFIC, PTE. LTD., TAIWAN BRANCH

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a Phase 3, prospective, open-label, multicenter study to assess the efficacy of NH002-enhanced echocardiography in subjects with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the left ventricular endocardial border delineation compared with unenhanced echocardiography. The study also aims to investigate the safety and tolerability of NH002.

CONDITIONS

Official Title

Safety and Efficacy Evaluation of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Ability to understand and provide written informed consent
  • Diagnosis or suspicion of cardiac disease
  • Underwent a transthoracic echocardiogram within 30 days prior showing suboptimal left ventricular border visualization with 2 or more segments not clearly seen in standard apical views
Not Eligible

You will not qualify if you...

  • Presence of severe or unstable heart, lung, or systemic conditions unsuitable for the study, including:
    • Acute coronary syndrome within 6 months
    • Uncontrolled serious ventricular arrhythmias
    • Decompensated or uncontrolled congestive heart failure (NYHA Class IV)
    • Atrial fibrillation or uncontrolled cardiac arrhythmias causing symptoms or hemodynamic issues
    • Uncontrolled hypertension (systolic >200 mmHg, diastolic >110 mmHg, or systolic ≤90 mmHg)
    • Acute aortic dissection
  • Known or suspected allergy to NH002, perflutren, Definity®, or other echocardiographic contrast agents
  • Known or suspected allergy to polyethylene glycol or reactions to related products like colonoscopy preparations or certain laxatives
  • Received any investigational drugs within 30 days before enrollment
  • Received any contrast agents within 48 hours before NH002 administration
  • Pregnant or breastfeeding females; pregnancy must be excluded by testing, contraception use, surgical history, or postmenopausal status
  • Serious medical or psychiatric conditions likely to interfere with study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Keelung Chang Gung Memorial Hospital & Lovers Lake Branch

Keelung, Taiwan, 204201

Actively Recruiting

2

China Medical University Hospital

Taichung, Taiwan, 404327

Actively Recruiting

3

MacKay Memorial Hospital

Taipei, Taiwan, 104217

Actively Recruiting

4

Cathay General Hospital

Taipei, Taiwan, 106438

Actively Recruiting

5

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Actively Recruiting

6

National Taiwan University Hospital Hsin-Chu Branch

Zhubei, Taiwan, 302058

Actively Recruiting

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Research Team

S

Shih-Tsung Kang, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Safety and Efficacy Evaluation of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography | DecenTrialz