Fatty Acid Radiotracer Comparison Study in Heart Failure Patients

PET imaging will be broken down into 2 groups of subjects (dosimetry and kinetic dynamic
imaging/[11C]palmitate comparison) with entry into these groups will occur simultaneously.
All PET imaging will be performed with a Siemens Biograph 40 PET-CT scanner. All patients
will undergo routine clinical evaluation as dictated by the treating heart failure
cardiologist. The results of the PET studies will not be provided to the patient or the
treating cardiologist unless, in the judgment of the Principal Investigator, the images
demonstrate an unsuspected abnormality that may warrant further evaluation. Subjects will be
instructed not to eat after midnight the night before the study. However, patients will be
instructed to continue their heart failure and diabetic medical regimens. The morning of
their PET study, subjects will have two intravenous catheters placed. One will be placed in
each arm for the purpose of administering radioactive tracers ([15O]Water, [11C]Palmitate,
and [18F]FluorbetaOx), drawing blood samples for safety laboratory analysis. Urine samples
will be obtained along with an Electrocardiogram (ECG) and vital signs. A follow-up telephone
contact will be done 2-3 days post imaging study to capture unanticipated and serious adverse
events (SAEs).

Inclusion Criteria:

- Male or female between 18 and 75 years of age inclusive, at the time of signing the
informed consent

- Chronic dilated cardiomyopathy of non-ischemic origin

- New York Heart Association (NYHA)Class II/III heart failure for a minimum of 6 months
prior to enrollment

- Heart Failure patients with Left Ventricular Ejection Fracture less than or equal to
35%

- Obesity defined as Body Mass Index of ≥ 30kg/m2

- Type 2 Diabetes Mellitus based on standard American Diabetes Association (ADA)
criteria

- Capable of giving informed consent

- Not currently pregnant or nursing: Female subjects must be either: surgically sterile
(has had a documented bilateral oophorectomy and/or documented hysterectomy),
postmenopausal (cessation of menses for more than 1 year), or of childbearing
potential for whom a urine pregnancy test (with the test performed within the 24 hour
period immediately prior to administration of [18F] FluorbetaOx is negative

Exclusion Criteria:

- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of screening

- A recent positive pre-study drug/alcohol screen noted in medical records

- Pregnant females as determined by positive (serum or urine) human chorionic
gonadotropin(hCG) test at screening or prior to dosing

- Lactating females

- Unwillingness or inability to follow the procedures outlined in the protocol

- Subject is mentally or legally incapacitated

- History of a psychiatric disorder that will affect the subject's ability to
participate in the study

- Restrictive, obstructive, or infiltrative cardiomyopathy; pericardial disease;
uncorrected thyroid disease (TSH) noted in medical records

- History of clinically significant coronary artery disease (CAD)including (prior (ST)
elevation myocardial infarction, presence of ≥ 50% obstruction of a major coronary
artery, and presence of angina)

- Contraindications to PET scanning (i.e., inability to lie flat with arms over head for
up to 1½ hours; claustrophobia; current participation in research studies involving
radiation exposure such that the total research-related radiation dose to the subject
in any given year would exceed the Code of Federal Regulation limits