Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView.

Ventricular Dysfunction, Left Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936649
• Other study ID #: GE-122-015
• Status: Completed
• Phase: Phase 4
• First received: September 3, 2013
• Last updated: February 9, 2015
• Start date: February 2014
• Est. completion date: February 2014

Study information

• Verified date: February 2015
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure (HF)
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Drug:
• AdreView
AdreView 10 millicuries (mCi) as a single iv. administration

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
GE Healthcare	H2O Clinical LLC, Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test-retest Reproducibility on Measurements of Heart/Mediastinum (H/M) Ratio and the Extent of the Difference Between H/M Measurements Following AdreView and 3 Hour 50 Minute Delayed Planar Imaging on 2 Separate Days Within an Interval of 5 to 14 Days.	The summary statistics for the results from the two 3-hour 50-minute delayed planar imaging sessions for each subject and the absolute difference between the test and retest Heart/Mediastinum (H/M) ratios.	Two separate AdreView™ SPECT scintigraphy imaging days within an interval of 5 to 14 days.	No
Secondary	Test-retest Reproducibility on Measurements of Heart/Mediastinum (H/M) Ratio and Extent of the Difference Between H/M Measurements Following AdreView Use and 15 Minute Delayed Planar Imaging on 2 Separate Days Within an Interval of 5 to 14 Days.	The summary statistics for the results from the two 15-minute delayed planar imaging sessions for each subject and the absolute difference between the test and retest Heart/Mediastinum (H/M) ratios.	Two separate AdreView SPECT scintigraphy imaging days within an interval of 5 to 14 days.	No