Status:
TERMINATED
Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction
Lead Sponsor:
GE Healthcare
Conditions:
Diabetes Mellitus
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 Pr...
Eligibility Criteria
Inclusion
- The subject is between 18 and 80 years of age.
- The subject was diagnosed with DM type 2 based upon accepted clinical criteria and currently takes at least one diabetes medication.
- For HF subjects: The subject was diagnosed with HF with preserved EF within the previous 1 year, at which time LVEF was determined to be ≥45%.
- For comparison subjects: The subject was determined to have diastolic dysfunction on EKG within the previous year and currently has no signs or symptoms of HF.
- The subject has been clinically stable for at least 7 days prior to the study imaging procedures (e.g., not experiencing continuing chest pain, hemodynamic instability, worsening HF symptoms, or clinically significant arrhythmia).
Exclusion
- The subject had an acute myocardial infarction within the past 30 days.
- The subject had a cardiac revascularization (e.g., percutaneous transluminal coronary angiography \[PTCA\], percutaneous coronary intervention (PCI), or coronary artery bypass graft \[CABG\]) within the past 30 days.
- The subject has severe renal dysfunction.
- The subject is claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to 20 minutes at a time.
- The subject has participated in a research study using ionizing radiation in the previous 12 months.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01440517
Start Date
August 1 2011
End Date
March 1 2012
Last Update
February 4 2014
Active Locations (1)
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1
GE Healthcare
Princeton, New Jersey, United States, 08540