Fatty Acid Radiotracer Comparison Study in Heart Failure Patients

• Status: Completed
• Trial end date: 2014-06-04
• Target enrollment: 0
• Participant gender: All

Summary

A single center, open-label baseline controlled imaging study to designed to assess whether Positron Emission Tomography (PET) measurements of myocardial Fatty Acid (FA) metabolism performed with [18F]FluorbetaOx correlates with measurements using [11C]palmitate. This study involves the investigational use of a PET radioactive tracer, fluorine-18 radiolabeled fatty acid analog, [18F]FluorbetaOx designed to measure beta oxidation of fatty acids in the myocardium. The investigators propose to evaluate the feasibility of the method in heart failure patients with dilated non-ischemic cardiomyopathy (DCM) with or without type-2 diabetes mellitus (T2DM) and obese subjects (Body Mass Index of ≥ 30kg/m2) with or without T2DM and normal healthy subjects to provide a wide range of perturbations in myocardial FA metabolism.

Specific objectives include:

1. To assess the diagnostic quality of [18F]FluorbetaOx PET images and kinetics at the proposed 10 millicurie (mCi) dose.

2. To quantitatively determine the relationship between PET measurements of myocardial FA metabolism obtained with [18F]FluorbetaOx and those using [11C]Palmitate.

3. To calculate human dosimetry based on the human biodistribution of [18F]FluorbetaOx.

4. Correlate measurements of myocardial FA metabolism with changes in left ventricular (LV)structure and function performed on a clinically indicated echocardiography at 6-9 months after imaging.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine

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