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

Trust Bio-sonics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cardiac Disease

Treatments: Diagnostic Test: Echocardiogram; Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04185246

NH002-LV

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Single arm

Experimental group

Description:

Subjects will be enrolled with sequential allocation to 1 of 3 cohorts with the following intravenous (IV) doses of NH002: 2.5 µl/kg, 5.0 µl/kg, or 10.0 µl/kg. Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day

Treatment:

Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension

Diagnostic Test: Echocardiogram