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Genetic Determinants of Hemodynamic Response to Esmolol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: July 3, 2011
Last updated: July 5, 2011
Last verified: July 2011

July 3, 2011
July 5, 2011
July 2011
May 2015   (final data collection date for primary outcome measure)
Change in heart rate during exercise [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
continous measurement of heart rate
Same as current
No Changes Posted
change in systolic blood pressure during exercise [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
measurement of systolic blood pressure every 5 minutes
Same as current
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Genetic Determinants of Hemodynamic Response to Esmolol
A Study in Healthy Subjects to Evaluate Genetic Determinants of the Variability in Hemodynamic Response to Esmolol

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.

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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Decrease in Heart Rate Below Baseline Value
Drug: esmolol
consecutive infusions of esmolol and normal saline (placebo)
Experimental: esmolol infusion
infusion of esmolol during rest and exercise
Intervention: Drug: esmolol
Muszkat M, Hoofien A, Orlanski-Meyer E, Makhoul H, Porat E, Davidson EM, Blotnick S, Caraco Y. The common Arg389gly ADRB1 polymorphism affects heart rate response to the ultra-short-acting β(1) adrenergic receptor antagonist esmolol in healthy individuals. Pharmacogenet Genomics. 2013 Jan;23(1):25-8. doi: 10.1097/FPC.0b013e32835afde6.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
May 2015   (final data collection date for primary outcome measure)

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
18 Years to 50 Years   (Adult)
Contact: Mordechai Muszkat, MD 972-2-6777111 ext 73793
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Mordechai Muszkat, MD, Hadassah- Hebrew University Medical Center
Hadassah Medical Organization
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Not Provided
Hadassah Medical Organization
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP