Fatty Acid Radiotracer Comparison Study in Heart Failure Patients

Completed · Early Phase 1

Conditions studied: Heart Failure, Obesity, Type 2 Diabetes Mellitus, Health Normal Volunteer Subjects

In brief

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.

Key facts

Study ID

NCT01648296

Run by

Washington University School of Medicine

People needed

50

Starts

2012-09-13

Expected to finish

2014-06-04

Last updated by the study team

2020-02-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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