Loading clinical trials...

Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView. | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

A Phase 4, Open-label Test-retest Study to Assess the Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView (Iobenguane I 123 Injection)

NCT01936649•GE Healthcare

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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™.
+3 more criteria

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Key Dates

Start Date

August 1, 2013

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2014

Last Updated

December 8, 2016

Enrollment

ACTUAL participants

Conditions

Heart Failure (HF)Ventricular Dysfunction, Left

Interventions

AdreView (Iobenguane I 123 Injection)

DRUG

Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy

NCT07372196

HCM - Hypertrophic CardiomyopathySudden Cardiac Death+3 more

View study

ACTIVE_NOT_RECRUITINGNA

BioVentrix Revivent TC™ System Clinical Study

NCT02931240

Ventricular Dysfunction, Left

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy

BioVentrix Revivent TC™ System Clinical Study

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

A Study Called NATION-OS to Learn About the Link Between N-terminal proBNP (NT-proBNP) Levels and Medical Problems Due to Heart Failure (HF) in German Patients With HF

Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)

SchlaHF-XT-Register. Sleep Disordered Breathing in Heart Failure Register