A Multicenter, Open-Label, Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography
Overview
- Phase
- Phase 1
- Intervention
- NH002 (Perflutren Lipid Microspheres) Injectable Suspension
- Conditions
- Cardiac Disease
- Sponsor
- Trust Bio-sonics, Inc.
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Rate of Any Potential Adverse Allergic Reaction
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects 20 years of age or older
- •Ability to understand and the willingness to provide written informed consent
- •Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease
- •Negative pregnancy test within 24 hours of the procedure if subject is a woman of childbearing potential
Exclusion Criteria
- •Known right-to-left, bidirectional, or transient right-to-left cardiac shunt(s)
- •Chronic obstructive pulmonary disease
- •Ejection fraction at screening or baseline \<40%
- •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)
- •Clinically significant abnormality in renal and liver function tests (alanine aminotransferase/aspartate aminotransferase \>2 × upper limit of normal \[ULN\]; serum creatinine \> 1.5 × ULN)
- •Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, or other echocardiographic contrast agent
- •Received an investigational compound within 30 days before enrolling in the study
- •Received any contrast agent either intravascularly or orally within 48 hours before NH002 administration
- •Pregnant or lactating female (conception during the study should be avoided)
- •Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research
Arms & Interventions
Single arm
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
Intervention: NH002 (Perflutren Lipid Microspheres) Injectable Suspension
Single arm
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
Intervention: Echocardiogram
Outcomes
Primary Outcomes
Rate of Any Potential Adverse Allergic Reaction
Time Frame: From pre-injection to 240 minutes post-injection
Monitor for any potential adverse allergic reaction
12-lead ECGs
Time Frame: From pre-injection to 60 minutes post injection
Standard 12-lead ECGs will be assessed from pre-injection to 60 minutes post-injection for changes in QT/ corrected QT(QTc) interval (in ms) and ECG morphology; each standard 12-lead ECG assessment will be scored as either normal or abnormal
Body Temperature
Time Frame: From pre-injection to 120 minutes post injection
Monitor for any changes in body temperature (in Celsius degree)
Respiratory Rate
Time Frame: From pre-injection to 120 minutes post injection
Monitor for any changes in respiratory rate (in breaths/min)
Blood Pressure
Time Frame: From pre-injection to 120 minutes post injection
Monitor for any changes in blood pressure (in mmHg)
Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)
Time Frame: From pre-injection to 240 minutes post-injection
Monitor for any changes in TT and aPTT
Cardiac Troponin I
Time Frame: pre-injection and 240 minutes post-injection
Monitor for any changes in Cardiac troponin I
Heart Rate
Time Frame: From pre-injection to 120 minutes post injection
Monitor for any changes in heart rate (in beats/min)
Oxygen Saturation by Pulse Oximetry (SpO2)
Time Frame: From pre-injection to 120 minutes post-injection
Monitor for any changes in SpO2
Cardiac Troponin T
Time Frame: pre-injection and 240 minutes post-injection
Monitor for any changes in Cardiac troponin T
Secondary Outcomes
- Left Ventricular Opacification (LVO)(Image data obtained pre-injection and within 10 minutes post-injection)
- Left Ventricular Endocardial Border Delineation (LVEBD)(Image data obtained pre-injection and within 10 minutes post-injection)
- Duration of Clinically Useful Contrast(Image data obtained pre-injection and within 10 minutes post-injection)