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Clinical Trials/NCT01388036
NCT01388036UnknownNot Applicable

A Study in Healthy Subjects to Evaluate Genetic Determinants of the Variability in Hemodynamic Response to Esmolol

Hadassah Medical Organization1 site in 1 country100 target enrollmentStarted: July 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
Change in heart rate during exercise

Study Overview

Brief Summary

Beta 1 Adrenergic antagonists (beta blockers) have major role in the treatment of CHF, IHD and hypertension. However, there is large interindividual variability in the response to beta blockers.

The hypothesis underlying this study is that genetic differences between individuals will determine the individual response to esmolol, a betablocker that is administered intravenously. Esmolol will be administered intravenously to healthy volunteers, and the effects on heart rate and blood pressure will be monitored. In addition, we will measure plasma renin activity and plasma levels of norepinephrine.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • healthy male and female
  • able to understand and sign informed consent

Exclusion Criteria

  • consumption of any medication
  • bradycardia <50 BPM
  • hypersensitivity to beta blockers

Arms & Interventions

esmolol infusion

Experimental

infusion of esmolol during rest and exercise

Intervention: esmolol (Drug)

Outcomes

Primary Outcomes

Change in heart rate during exercise

Time Frame: 3 hours

continous measurement of heart rate

Secondary Outcomes

  • change in systolic blood pressure during exercise(3 hours)

Investigators

Sponsor Class
Other

Study Sites (1)

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