Heart Failure (HF)Phase 4NCT01936649
Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView.
A Phase 4 study testing AdreView (Iobenguane I 123 Injection) in people with Heart Failure (HF) and Ventricular Dysfunction, Left, run by GE Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure (HF), Ventricular Dysfunction, Left
- What is being tested?
- AdreView (Iobenguane I 123 Injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Feb 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Heart Failure (HF), Ventricular Dysfunction, Left
- Being tested
- AdreView (Iobenguane I 123 Injection)
- Keywords
- Nuclear imaging, Radiopharmaceutical, Iobenguane, I-123, reproducibility, Quantitative measurements, myocardial uptake, SPECT imaging, planar imaging, AdreView™
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdreView (Iobenguane I 123 Injection)Drug
Also called meta-iodobenzylguanidine (123 I-mIBG)
AdreView 10 mCi as a single i.v administration
| Study group | Role | What they receive |
|---|---|---|
| AdreView (Iobenguane I 123 Injection) | Experimental | Two administrations of single intravenous (i.v) injection of Iobenguane I 123 10 millicuries (mCi) (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days. Receives: Drug: AdreView (Iobenguane I 123 Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake in Heart Failure (HF) Participants on Planar Imaging at 3 Hours 50 Minutes Following I.V. Injection of AdreView (Iobenguane I 123 Injection)
Participants underwent 2 AdreView (Iobenguane I 123 Injection) exams on the same gamma camera within 5 to 14 days, with the requirement that there was no change in the clinical condition of the participant or in the imaging equipment between the 2 procedures. Each imaging study was processed and read independently by 3 technologists. Mean heart/mediastinum (H/M) ratio difference (with 95% confidence interval [CI]) was used as the measure of test stability.
Measured: 3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 days
Secondary outcomes (1)
To Assess the Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake on Planar Imaging at 15 Minutes Following Administration of AdreView (Iobenguane I 123 Injection)
Measurements of H/M ratio and the extent of difference between H/M measurements following AdreView administration and 15 minutes delayed planar imaging on 2 separate days within an interval of 5 to 14 days, was used to assess the test-retest reproducibility. Data from test-retest study was used to estimate the normal ranges for variation in quantitation of myocardial tracer uptake using AdreView. H/M ratios were calculated by 3 technologists and average of 3 technologists was calculated based on non-missing technologists reviewing results. All non-missing technologist evaluations were averaged per participant.
Measured: 15 minutes post administration of 2 dosing within an interval of 5 to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Failure (HF)Studies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H2O Clinical LLC, Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Arnold Jacobson, M.D., Study chair, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936649
- Sponsor's protocol ID
- GE-122-015
- Status last verified
- Oct 2016
- First submitted
- 3 Sep 2013
- Last updated
- 8 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01936649
- Acronym / sponsor ID
- GE-122-015
- Conditions
- Heart Failure (HF), Ventricular Dysfunction, Left
- Keywords
- Nuclear imaging, Radiopharmaceutical, Iobenguane, I-123, reproducibility, Quantitative measurements, myocardial uptake, SPECT imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- H2O Clinical LLC, Quintiles, Inc.
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Posted 26 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AdreView (Iobenguane I 123 Injection) | Experimental | Drug: AdreView (Iobenguane I 123 Injection)Two administrations of single intravenous (i.v) injection of Iobenguane I 123 10 millicuries (mCi) (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdreView (Iobenguane I 123 Injection)Also: meta-iodobenzylguanidine (123 I-mIBG)AdreView 10 mCi as a single i.v administration | Drug | AdreView (Iobenguane I 123 Injection) |
Primary outcome
To Assess Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake in Heart Failure (HF) Participants on Planar Imaging at 3 Hours 50 Minutes Following I.V. Injection of AdreView (Iobenguane I 123 Injection)
Time frame: 3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 days
Participants underwent 2 AdreView (Iobenguane I 123 Injection) exams on the same gamma camera within 5 to 14 days, with the requirement that there was no change in the clinical condition of the participant or in the imaging equipment between the 2 procedures. Each imaging study was processed and read independently by 3 technologists. Mean heart/mediastinum (H/M) ratio difference (with 95% confidence interval [CI]) was used as the measure of test stability.
1 secondary outcome
To Assess the Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake on Planar Imaging at 15 Minutes Following Administration of AdreView (Iobenguane I 123 Injection)
Time frame: 15 minutes post administration of 2 dosing within an interval of 5 to 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnold Jacobson, M.D. study chair
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AdreView (Iobenguane I 123 Injection) in people with Heart Failure (HF) and Ventricular Dysfunction, Left, run by GE Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Assess Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake in Heart Failure (HF) Participants on Planar Imaging at 3 Hours 50 Minutes Following I.V. Injection of AdreView (Iobenguane I 123 Injection) (time frame: 3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.