Clinical trial NCT02127307: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure (HF)
Keywords: Myocardial sympathetic innervation
Heart failure (HF)
Nuclear imaging
Radiopharmaceutical
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: H2O Clinical LLC
name: Quintiles, Inc.
First posted: 2014-04-30
Enrollment: 964
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Jose Zubeldia, M.D.
role: STUDY_CHAIR
References: