MedTrace Logo

Regression of Myocardial Steatosis by Nebivolol

NCT01358409 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-07-14

No results posted yet for this study

Summary

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.

Conditions

  • Cardiac Steatosis and Lipotoxicity

Interventions

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.

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Lidia Szczepaniak

    lead OTHER

Principal Investigators

  • Lidia S Szczepaniak, PhD · Cedars-Sinai Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-01
Primary Completion
2013-02-11
Completion
2013-02-11

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358409 on ClinicalTrials.gov