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.

Heart Failure (HF) Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127307
• Other study ID #: GE-122-016
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: August 10, 2016
• Start date: February 2014
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCzech Republic: State Institute for Drug ControlPoland: Ministry of Health
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: April 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure (HF)

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
GE Healthcare	H2O Clinical LLC, Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate the prognostic usefulness of assessment of myocardial sympathetic innervation	Demonstrate the prognostic usefulness of assessment of myocardial sympathetic innervation, as reflected by the heart to mediastinum (H/M) ratio on planar AdreView™ (123I mIBG) imaging dichotomized as either <1.60 or =1.60, for identifying heart failure (HF) subjects at lower risk of death during 60 months of follow-up.	AdreView™ image scans were previously acquired according to AdreView™ studies, MBG311 or MBG312. Estimated time to collect new information in this study is 6 months.	No
Secondary	Demonstrate that for heart failure (HF) subjects with moderate and severe abnormal myocardia sympathetic innervation	Demonstrate that for heart failure (HF) subjects with moderate and severe abnormal myocardia sympathetic innervation, as measured by the numerical H/M ratio on planar AdreView™ imaging dichotomized as either 1.20-1.59 or <1.20, both groups are at higher risk of death during 60 months of follow-up than HF subjects with H/M=1.60.	AdreView™ image scans were previously acquired according to AdreView™ studies, MBG311 or MBG312. Estimated time to collect new information in this study is 6 months.	No