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

 -  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 Criteria:

 -  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.