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.

NCT02127307 | Completed Results

• 1 other identifier: GE-122-016
• Study Type: observational
• Target: 964
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure (HF)

Keywords

Myocardial sympathetic innervation; Heart failure (HF); Nuclear imaging; Radiopharmaceutical

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• H2O Clinical LLC: collaborator
• Quintiles, Inc.: collaborator

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Jose M Zubeldia, M.D.
• Organization: GE Healthcare

jose.zubeldia@ge.com

011-44-1494-5431347

Study Officials

• Jose Zubeldia, M.D.

  GE Healthcare

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: April 30, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2016
• Last Updated: March 28, 2017
• Results First Posted: March 28, 2017

Record last verified: 2017-02

Locations

US (1)