Phase 4 Study to Demonstrate Prognostic Usefulness of AdreView™ Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience Death During 60 Months Follow-up.

An Open-Label, Multicenter, Phase 4 Study to Demonstrate the Prognostic Usefulness of AdreView™ Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience Death During 60 Months Follow-up.

This aim of the study is to investigate the prognostic usefulness of AdreView™ imaging to identify those subjects with New York Heart Association (NYHA) Class II or III HF who will die during 60 months of follow-up from the date of administration of AdreView™ in prior studies MBG311, MBG312, or MBG312C (hereafter included in MBG312).

Study Overview

• Status: Completed
• Conditions: Heart Failure (HF)

• Study Type: Observational
• Enrollment (Actual): 964

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • GE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Heart Failure patients (NYHA Class II or III) with left ventricular ejection fraction ≤35% at time of enrolment in MBG311 or MBG312.

Description

Inclusion Criteria:

• The subject was a HF subject who had signed informed consent for MBG311 or MBG312.
• The subject was administered AdreView™ in MBG311 or MBG312.
• The subject completed the late planar imaging assessments (at a minimum) required by the protocols for MBG311 and MBG312, and those images were read and judged diagnostic by at least 2 blinded readers.
• In addition, all subjects must meet 1 of the following 3 inclusion criteria.
• If the subject can be located, he/she provides informed consent to allow the investigator access to medical records and/or gives permission for the investigator to speak to treating physicians.
• If the subject can be located and he/she declines to provide informed consent, the IRB/EC provides a waiver of consent to allow the investigator to record that the subject is alive.
• If the subject cannot be located, the IRB/EC provides a waiver of consent to allow the investigator to access available medical records for care provided subsequent to last date of subject participation in MBG311, MBG312, and/or MBG313 and/or to allow collection of data from publicly available sources.

Exclusion Criteria:

• The subject withdrew or was withdrawn from MBG311 or MBG312 because of a protocol violation.
• The subject underwent heart transplantation during MBG311, MBG312, or MBG313.
• The subject was recorded to have died during MBG311, MBG312, or MBG313.
• The subject voluntarily withdrew from MBG311, MBG312, or MBG313, and the IRB/EC has not provided a waiver to allow recording of subject survival status in such an instance.
• The subject cannot be located, cannot be contacted, and no information can be found to establish survival status beyond the date of last contact in MBG311, MBG312, or MBG313, including information available as a result of an IRB/EC-approved waiver.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship Between the Occurrence of Death and 123I-mIBG Uptake on Planar Scintigraphy With Heart to Mediastinum (H/M) Ratio of <1.60 vs H/M ≥1.60	H/M ratio for 123I-mIBG uptake 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. H/M ratios were categorized as 'Low' and 'High' based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data, as reflected by the H/M ratio, for identifying HF participants at lower risk of death during 60 months of follow-up.	From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Quintiles, Inc.; H2O Clinical LLC
• Investigators: Study Chair: Jose Zubeldia, M.D., GE Healthcare

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Radiopharmaceutical; Nuclear imaging; Heart failure (HF); Myocardial sympathetic innervation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: GE-122-016