Overview

This trial is active, not recruiting.

Conditions heart failure (hf), ventricular dysfunction, left
Treatment adreview
Phase phase 4
Sponsor GE Healthcare
Collaborator H2O Clinical LLC
Start date August 2013
End date June 2014
Trial size 45 participants
Trial identifier NCT01936649, GE-122-015

Summary

The aim of the study is to assess the reproducibility of quantitative measurements of myocardial uptake of Iobenguane I 123 on planar and SPECT imaging following intravenous (iv.) administration of AdreView. Efficacy will be assessed based upon the absolute differences between quantitative analyses of imaging data on 2 scans performed 5 to 14 days apart.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
adreview I-123 Iobenguane injection
AdreView 10 millicuries (mCi) as a single iv. administration

Primary Outcomes

Measure
Test-retest reproducibility of Iobenguane I 123 myocardial uptake in heart failure (HF) subjects on planar imaging
time frame: Time zero equals the date of radiopharmaceutical imaging and up to 4 hours post administration of AdreView

Secondary Outcomes

Measure
Test-retest reproducibility of Iobenguane I 123 myocardial uptake on single photon emission computed tomography (SPECT)
time frame: Time zero equals the date of radiopharmaceutical imaging and up to 4 hours post administration of AdreView

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - The subject was originally diagnosed with NYHA Class II-III HF due to ischemic heart disease at least 3 months or due to non-ischemic cardiomyopathy at least 6 months before enrolment into the study. - The subject has Left Ventricular (LV) dysfunction with Left Ventricular Ejection Fraction (LVEF) less than or equal to 35% measured by an appropriate method (e.g., radionuclide or contrast ventriculography, electrocardiogram (ECG)-gated SPECT myocardial perfusion imaging [MPI], magnetic resonance imaging, CT or echocardiography) within 6 months of enrolment into the study and documented in the subject's medical record. - The subject has a history of compliance with prescribed HF medications and takes Heart Failure (HF) guidelines-based medication at study entry including at a minimum a beta-blocker and either an angiotensin converting enzyme inhibitor or angiotensin receptor antagonist unless documented to be intolerant to any of these classes of medications. - The subject has been on a stable medical regimen for a minimum of 3 months, with no hospitalizations or change in HF medications or HF symptoms. - Subjects must be clinically stable for at least 7 days before enrolling in the study (e.g., not experiencing continuing chest pain or hemodynamic instability). Exclusion Criteria: - The subject has previously received 123I-mIBG or 131I-mIBG. - The subject has known or suspected hypersensitivity/allergy to iodine, Iobenguane or to any of the excipients in AdreView. - The subject has had a heart transplant at any time prior to enrollment. - The subject had LVEF greater than 35% as measured by an appropriate method (e.g., radionuclide or contrast ventriculography, ECG-gated SPECT MPI, MR, CT, or echocardiography) within 30 days prior to enrolment into the study. - The subject has received defibrillation (either external or via an implantable cardioverter defibrillator [ICD]), anti-tachycardia pacing, or cardioversion to treat an arrhythmic event in the previous 90 days. - The subject had a cardiac revascularization, insertion of an ICD, or acute myocardial infarction within 30 days before study entry. - The subject has renal insufficiency (creatinine greater than 3 mg/dl).

Additional Information

Official title A Phase 4, Open-label Test-retest Study to Assess the Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView™ (Iobenguane I 123 Injection)
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by GE Healthcare.