Fatty Acid Radiotracer Comparison Study in Heart Failure Patients
Heart Failure, Obesity, Type 2 Diabetes Mellitus

About this trial
This is an interventional basic science trial for Heart Failure focused on measuring Heart Failure, Obesity, Type 2 Diabetes Mellitus, Health Normal Volunteer Subjects
Eligibility Criteria
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Dosimetry Group
Kinetic Dynamic Group
A total of 12 subjects will receive a single intravenous injection of[18F]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy.
A total of 38 subjects will receive a single intravenous injection of [18F]FluorbetaOx, [11C]Palmitate, and [15O]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2.