Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event

An observational study of Congestive Heart Failure, run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study was designed to study the utility of meta-iodobenzylguanidine (123I-mIBG) imaging to identify those participants with heart failure who would experience an adverse cardiac event during 24 months of follow-up from the administration date of 123I-mIBG in previous studies MBG311 or MBG312. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Congestive Heart Failure
What is being tested?: I-123 mIBG
How many people: 471 participants
Where: 1 siteUnited States
Study dates: May 2008to Feb 2010
Phase: Observational
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

Study population: Heart Failure Participants who participated in: MBG311 (NCT00126425) and MBG312/312C (NCT00126438).

Who may be able to join

The subject was a Heart Failure subject who signed informed consent for MBG311, MBG312, or MBG312C.
The subject was administered 123I-mIBG in MBG311, MBG312, or MBG312C.
The subject completed the late planar imaging assessments (at a minimum) required by the protocols for MBG311, MBG312, or MBG312C.
The subject agreed to allow the investigator access to medical records, including those relating to subject death should this occur.

Who cannot join

The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.
The subject was considered lost-to-follow-up (6 months without contact) in MBG311, MBG312, or MBG312C.

Trial locations and contacts

1 site in 1 country.

United States1 site

GE Healthcare
Princeton, New Jersey, 08540

Other trials in United States

About this study

Official title: An Open-label, Multicentre, Phase 3 Study to Demonstrate the Prognostic Usefulness of 123I-mIBG Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event During 24 Months Followup

Conditions: Congestive Heart Failure
Being tested: I-123 mIBG
Keywords: Heart Failure, MIBG, 123I-mIBG
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

I-123 mIBGDrug
This was an observational study. Participants were previously dosed in separate study.

Study groups in NCT00785044
Study group	Role	What they receive
Group		No participants received any drug administration. No intervention conducted. Receives: Drug: I-123 mIBG

What is being measured

The primary outcome is the main question the study is designed to answer.

Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status
The numerical value of 123 I-mIBG uptake (H/M ratio) at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis.
Measured: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Feb 2010

First posted5 Nov 2008 (estimated)
Study startMay 2008
Primary completionJan 2010
Study completionFeb 2010

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 Congestive Heart FailureStudies 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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 471 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00785044
Sponsor's protocol ID: MBG313
Status last verified: Apr 2017
First submitted: 4 Nov 2008
Last updated: 26 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Congestive Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multicentre, Phase 3 Study to Demonstrate the Prognostic Usefulness of 123I-mIBG Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event During 24 Months Followup
ClinicalTrials.gov ID: NCT00785044
Acronym / sponsor ID: MBG313
Conditions: Congestive Heart Failure
Keywords: Heart Failure, MIBG, 123I-mIBG
Study type: Observational
Recruitment status: Completed
Enrolment: 471 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Jan 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 5 Nov 2008 (estimated)
Results: Posted 26 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Group	–	Drug: I-123 mIBGNo participants received any drug administration. No intervention conducted.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Heart Failure Participants who participated in: MBG311 (NCT00126425) and MBG312/312C (NCT00126438).

Key inclusion criteria (4 listed)

The subject was a Heart Failure subject who signed informed consent for MBG311, MBG312, or MBG312C.
The subject was administered 123I-mIBG in MBG311, MBG312, or MBG312C.
The subject completed the late planar imaging assessments (at a minimum) required by the protocols for MBG311, MBG312, or MBG312C.
The subject agreed to allow the investigator access to medical records, including those relating to subject death should this occur.

Key exclusion criteria (2 listed)

The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.
The subject was considered lost-to-follow-up (6 months without contact) in MBG311, MBG312, or MBG312C.

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
I-123 mIBGThis was an observational study. Participants were previously dosed in separate study.	Drug	Group

Primary outcome

Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status
Time frame: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months
The numerical value of 123 I-mIBG uptake (H/M ratio) at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis.

Results and safety

Results posted to the registry on 26 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AdreView™- Heart Failure Group	964	468

Primary outcome: Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status

Time frame: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months. Mean (Standard Deviation). Unit: Ratio

Measure	AdreView™ - HF Group (With No Adverse Cardiac Events) n = 829	AdreView™- HF Group (With Adverse Cardiac Events) n = 132
Value	1.451 (0.2033)	1.394 (0.1885)

AdreView™ - HF Group (With No Adverse Cardiac Events) vs AdreView™- HF Group (With Adverse Cardiac Events): Mean: 0.581 (95% CI 0.532 to 0.630), p <0.001, Z-statistic

Population analysed: Efficacy population was 961 participants who received IMP and had a consensus H/M ratio on 3 hour 50 minute planar image in MBG 311 or MBG 312. Here, number of participant analyzed = number of participants with available data for this endpoint.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AdreView™ - Heart Failure Group	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Designed as a continuation of original phase 3, but objectives were built around analyses of integrated data from both studies. Distinct from endpoints used in MBG311 and MBG312. No intent to analyze current study on single original study basis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Congestive Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

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.

John Strohmeyer study director

GE Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Congestive Heart Failure, 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 4 inclusion and 2 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 26 Apr 2017. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2017). 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?

Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status (time frame: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00785044.

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 26 Apr 2017.