NCT01440517

Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction

An Open-Label, Multicenter, Proof of Concept, Phase 2 Study Evaluating the Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular Ejection Fraction (HFPEF)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular Ejection Fraction (HFPEF) will be enrolled and imaged with 99mTc maraciclatide. In addition, a maximum of 10 subjects with DM and diastolic dysfunction but no diagnosis of heart failure (HF) will be enrolled and imaged with 99mTc-maraciclatide.

Conditions

• Diabetes Mellitus
• Heart Failure

Interventions

Type	Name	Description
DRUG	Tc99m-Maraciclatide	Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-09-26
• Last updated: 2014-02-04
• Results posted: 2014-02-04

Locations

1 site across 1 country: United States