Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView.
Condition: Heart Failure (HF); Ventricular Dysfunction, Left
MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Left
Intervention: AdreView (Iobenguane I 123 Injection)
Intervention description: AdreView 10 mCi as a single i.v administration
Intervention MeSH terms: 3-Iodobenzylguanidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nuclear imaging; Radiopharmaceutical; Iobenguane; I-123; reproducibility; Quantitative measurements; myocardial uptake; SPECT imaging; planar imaging; AdreView™

Summary:

      The aim of the study was to assess the reproducibility of quantitative measurements of
      myocardial uptake of Iobenguane I 123 on planar and single photon emission computed
      tomography (SPECT) imaging following intravenous (i.v.) administration of AdreView. Efficacy
      was assessed based upon the absolute differences between quantitative analyses of imaging
      data on 2 scans performed 5 to 14 days apart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant was originally diagnosed with New York Heart Association (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 enrollment into the study.

          -  The participant had 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 [MR] imaging, computed
             tomography [CT] or echocardiography) within 6 months of enrollment into the study and
             documented in the participant's medical record.

          -  The participant had a history of compliance with prescribed heart failure (HF)
             medications and took 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 participant had been on a stable medical regimen for a minimum of 3 months, with
             no hospitalizations or change in HF medications or HF symptoms.

          -  Participants must be clinically stable for at least 7 days before enrolling into the
             study (e.g., not experiencing continuing chest pain or hemodynamic instability).

        Exclusion Criteria:

          -  The participant had previously received 123 I-mIBG or 131 I-mIBG.

          -  The participant had known or suspected hypersensitivity/allergy to iodine, Iobenguane
             or to any of the excipients in AdreView.

          -  The participant had a heart transplant at any time prior to enrollment.

          -  The participant had LVEF >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 enrollment into the study.

          -  The participant had 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 participant had a cardiac revascularization, insertion of an ICD, or acute
             myocardial infarction within 30 days before study entry.

          -  The participant used any of the following medications: Amitriptyline and derivatives,
             imipramine and derivatives, other antidepressants that inhibit the norepinephrine
             transporter, antihypertensives that deplete norepinephrine stores or inhibit reuptake,
             sympathomimetic amines and cocaine.

          -  The participant had either NYHA Class I or NYHA Class IV HF at the time of study
             entry.

          -  The participant had renal insufficiency (creatinine >3 mg/dl).

          -  The participant had participated in a clinical trial involving IMP or devices within
             30 days prior to first administration of AdreView™.

          -  In the investigator's opinion, the participant's medical history included either
             extensive lifetime exposure to ionizing radiation (medical, occupational, other) or
             documented total radiation dose >50 mSv during the previous 5 years.

          -  The participant had experienced HF hospitalization, increased HF symptoms without
             hospitalization, or had a change or increase in HF medications during the previous 3
             months.

          -  The participant had a serious non-cardiac medical condition associated with
             significant elevation of plasma catecholamines, including pheochromocytoma.