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Regression of Myocardial Steatosis by Nebivolol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358409
First Posted: May 23, 2011
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Lidia Szczepaniak, Cedars-Sinai Medical Center
  Purpose
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.

Condition Intervention Phase
Cardiac Steatosis and Lipotoxicity Drug: Nebivolol Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Regression of Myocardial Steatosis by Nebivolol

Resource links provided by NLM:


Further study details as provided by Lidia Szczepaniak, Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Myocardial triglyceride content [ Time Frame: 6 months ]
    Regression of myocadial triglycerides using MR spectroscopy at two time points, one prior to receiving Nebivolol and six months after continuous low dose Nebivolol treatment.


Secondary Outcome Measures:
  • Cardiac function [ Time Frame: 6 months ]
    Cardiac systolic and diastolic function will be assessed with cardiac MRI at two time points, one prior to receiving low dose Nebivolol treatment and once after six months of Nebivolol treatment.

  • Regression of concentric cardiac remodeling [ Time Frame: 6 months ]
    Cardiac concentric remodeling will be assessed with cardiac MRI at two time points, one prior to receiving low dose Nebivolol treatment and once after six months of Nebivolol treatment.

  • Regression of steatosis in other non-adipocyte tissue [ Time Frame: 6 months ]
    Regression of steatosis in other non-adipocyte tissue, including skeletal muscle, liver, and pancreas, will be assessed with MR spectroscopy at two time points, one prior to receiving low dose Nebivolol treatment and once after six months of Nebivolol treatment.

  • Regression of subcutaneous fat [ Time Frame: 6 months ]
    Regression of subcutaneous fat will be assessed with cardiac MRI at two time points, one prior to receiving low dose Nebivolol treatment and once after six months of Nebivolol treatment.


Enrollment: 31
Study Start Date: April 1, 2011
Study Completion Date: February 11, 2013
Primary Completion Date: February 11, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nebivolol
Nebivolol (Bystolic® by Forest/Mylan) is a third-generation beta-blocker; it selectively blocks β1-adrenergic receptors and increases peripheral vasodilation.
Drug: Nebivolol
Day 1 - Patients will start Nebivolol 5 mg PO daily; after one month, if the subject has tolerated 5 mg PO Nebivolol, the dose will be increased to 10 mg PO daily. If the patients is unable to tolerate 5 mg PO Nebivolol, he/she will be discontinued from the study. After six months, medication will be tapered to 5 mg PO daily for two weeks. Medication will then be tapered to 2.5 mg PO daily for two additional weeks.
Other Name: Bystolic® by Forest/Mylan

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358409


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Lidia Szczepaniak
Forest Laboratories
Investigators
Principal Investigator: Lidia S Szczepaniak, PhD Cedars-Sinai Heart Institute
  More Information

Responsible Party: Lidia Szczepaniak, former Director of MR Spectroscopy laboratory, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01358409     History of Changes
Other Study ID Numbers: MTG_Neb01
First Submitted: May 20, 2011
First Posted: May 23, 2011
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by Lidia Szczepaniak, Cedars-Sinai Medical Center:
steatosis
MR spectroscopy
Nebivolol
cardiac MRI

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Nebivolol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs