An Exploratory Study of 18F-Labeled Hydroxyphenethylguanidines in Heart Failure Patients

Completed · Early Phase 1

Conditions studied: Cardiomyopathy

In brief

The main goal of this study is to test two new radioactive drugs, 4-\[18F\]fluoro-meta-hydroxyphenethylguanidine (\[18F\]4F-MHPG) and 3-\[18F\]fluoro-para-hydroxyphenethylguanidine (\[18F\]3F-PHPG) in human subjects with congestive heart failure. Evaluations of these imaging agents will include their uptake in heart, lungs and liver, their metabolic breakdown in blood, and their kinetics in the heart. Based on these studies, the better of the two drugs will be chosen for further studies in patients with heart disease. After the better compound is chosen, additional measures of its imaging properties, metabolism and pharmacokinetics will be done in subjects with heart failure.

Key facts

Study ID

NCT02669563

Run by

University of Michigan

People needed

16

Starts

2015-12-01

Expected to finish

2016-12-01

Last updated by the study team

2017-02-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-80y
• Cardiomyopathy (ischemic and non-ischemic)
• Left ventricular ejection fraction (LVEF) < 35%
• Clinically appropriate referral for surgical implantation of an implantable cardiodefibrillator (ICD) for primary prevention of sudden cardiac death
• Not claustrophobic
• Ability to lie flat for 90 min
• Give informed consent

You may not qualify if…

• Revascularization such as the placement of a stent or balloon angioplast in the preceding 40 days
• Renal dysfunction with eGFR < 50 mL/min/1.73 m2
• Currently taking medications or drugs that may alter PET scans of cardiac sympathetic nerve terminals with these tracers, including any of the following:
• Tricyclic antidepressants, which inhibit the norepinephrine transporter, such as amitriptyline, desipramine, imipramine, etc.
• Cold medications (e.g., Sudafed®, as they may contain sympathomimetic amines, such as phenylephrine, phenylpropanolamine, pseudoephedrine, etc.)
• Nasal decongestants (some use phenylephrine as the active agent)
• Cocaine (which inhibits the norepinephrine transporter)
• Tetrabenazine (Xenazine, which inhibits VMAT2 transporters on vesicles inside neurons)
• Monoamine oxidase inhibitors (MAOI)
• Some antihypertensive drugs (reserpine, labetalol, α-methyldopa, and clonidine)
• Pregnancy or lactation
• Claustrophobia
• Inability to lie flat for 90 min

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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