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Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00785044
First received: November 4, 2008
Last updated: April 28, 2010
Last verified: April 2010
History of Changes
  Purpose

In the past two years, subjects participated in a medical research study using the investigational drug called 123I-Iodine meta-iodobenzylguanidine (123I-mIBG)(pronounced "123 I oo dine-meta ioo doo ben zul gwan nid deen"). The sponsor of that study (GE Healthcare) is now interested in gathering data concerning heart failure subjects and cardiac events, since they were enrolled in the original study. There will be no injections of radioactive imaging agents or repeat imaging studies.


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Open-label, Multicentre, Phase 3 Study to Demonstrate the Prognostic Usefulness of 123I-mIBG Scintigraphy for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event During 24 Months Followup

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Demonstrate the prognostic usefulness of assessment of myocardial sympathetic innervation, measured by the numerical H/M ratio on planar 123I-mIBG imaging, for identifying heart failure subjects at higher risk of experiencing an adverse cardiac [ Time Frame: 24 months after dosing date in MBG 311/312/312C ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify the optimum H/M threshold that provides the best combination of Sensitivity and Specificity for identifying HF subjects at higher risk of experiencing an ACE during 24 months of follow-up. To demonstrate the prognostic usefulness of the heart [ Time Frame: 24 months after dosing date in MBG 311/312/312C ] [ Designated as safety issue: No ]

Enrollment: 471
Study Start Date: June 2008
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Heart Failure Subjects who participated in MBG 311/312/312C.

Criteria

Inclusion Criteria:

  • The subject was a Heart Failure subject who signed informed consent for MBG311, MBG312, or MBG312C.
  • The subject was administered 123I-mIBG in MBG311, MBG312, or MBG312C.
  • The subject completed the late planar imaging assessments (at a minimum) required by the protocols for MBG311, MBG312, or MBG312C.
  • The subject agrees to allow the investigator access to medical records, including those relating to subject death should this occur.

Exclusion Criteria:

  • The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.
  • The subject was considered lost-to-follow-up (6 months without contact) in MBG311, MBG312, or MBG312C.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785044

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: John Strohmeyer GE Healthcare
  More Information

No publications provided

Responsible Party: Arnold Jacobson, M.D., GE Healthcare
ClinicalTrials.gov Identifier: NCT00785044     History of Changes
Other Study ID Numbers: MBG313
Study First Received: November 4, 2008
Last Updated: April 28, 2010
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Denmark: Danish Medicines Agency

Keywords provided by GE Healthcare:
Heart Failure
MIBG
Meta-Iodobenzylguanidine

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
3-Iodobenzylguanidine
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013