GE-122-016: Prognostic Usefulness of AdreView
Research type
Research Study
Full 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
IRAS ID
146409
Contact name
Roxy Senior
Contact email
Sponsor organisation
GE Healthcare
Research summary
AdreView is a licensed radiopharmaceutical imaging agent that is taken internally. The emitted radiation is then captured by special cameras to form two-dimensional images. This phase 4 follow up, non-interventional study is designed to evaluate the usefulness of AdreView imaging for predicting long-term (minimum 5-year) prognosis of death and significant adverse events in patients with heart failure who participated in two previous clinical studies (MBG311 or MBG312).
Only heart failure subjects enrolled and dosed with AdreView in MBG311 and MBG312 will be eligible to participate. Potentially eligible patients are therefore already known and will be contacted by investigators and asked for their consent to determine and record their status and whether they have experienced certain cardiac events. Subject status will be determined as of the date of contact. A maximum of 860 subjects at approximately 55 centres in North America and Canada, and 25 centres in Europe will be expected to participate. Investigational sites will be selected for this study on the basis of their participation in MBG311 or MBG312.
No new AdreView imaging will be performed as part of this trial and therefore no new safety data will be collected.
All subjects will complete the informed consent form before collection of any study information. For patients who are deceased or cannot be located only information available in publically accessible databases (e.g the death register) will be recorded. In addition, it is requested that for those who refuse to give consent, they can be marked as alive in the study database.
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/0313
Date of REC Opinion
28 Apr 2014
REC opinion
Further Information Favourable Opinion