Regression of Myocardial Steatosis by Nebivolol

Completed · Early Phase 1

Conditions studied: Cardiac Steatosis and Lipotoxicity

In brief

Within large number of patients with obesity, it is crucial to determine who is at the greatest risk for development of chronic heart disease. The investigators previous studies suggest that an excessive accumulation of fat in heart cells precedes the development of obesity-related pathologies and may serve as a biomarker of heart disease in high-risk population. Until now, the evaluation of fat in the human heart was possible postmortem or by biopsy. The investigators novel magnetic resonance spectroscopy technique enables the quantification of intracellular lipid content non-invasively and repeatedly in humans in vivo. It could be used to better screen and treat obese patients at risk for the development of metabolic disease. The investigators hypothesize that in obese humans with elevated myocardial triglycerides, treatment with Nebivolol will reduce myocardial fat and will improve heart function.

Key facts

Study ID

NCT01358409

Run by

Lidia Szczepaniak

People needed

31

Starts

2011-04-01

Expected to finish

2013-02-11

Last updated by the study team

2017-07-14

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mexican American men and women
• Age 18 - 59
• Metabolic Syndrome*
• Myocardial TG > or = to 0.5% by localized MR spectroscopy
• Metabolic syndrome in our study will follow the NCEP ATP III (National Cholesterol Education Program Adult Treatment Panel III) Guidelines which include > or = to 3 of the following:
• Fasting blood glucose > or = to 100 mg/dL
• Waist circumference: Men > 102 cm, Women > 88 cm
• Triglycerides > or = to 150 mg/dL
• BP > 130/85

You may not qualify if…

• Current use of a beta-blocker
• HR < 50 beats/min or BP < 130/85
• Contraindication to beta-blocker therapy such as asthma, reactive airway disease, heart block, or depression
• CHF (any NYHA class) by history, physical examination, or current use of CHF medication including beta-blockers, ACE inhibitors, angiotensin receptor blockers (ARBs), diuretics, calcium channel blockers, digitoxin, hydralazine, nitrates (including sublingual nitroglycerin), and inotropic agents
• LVEF < 50% by cardiac MRI
• Hepatic insufficiency or current use of another medication that is also metabolized by the CYP2D6 isozyme (paroxetine, fluoxetine, quinidine, propafenone).
• Any contraindication to MRI, e.g. metallic implants, metallic tattoos, claustrophobia, weight > 350 pounds (the MRI weight limit)
• Pregnancy at any time during the study
• A recent weight loss (>10% of body weight within the past year) or plans to undergo significant weight reduction (>10% of body weight) during the experimental protocol.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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