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Genetic Determinants of Hemodynamic Response to Esmolol

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01388036
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
Complete list of historical versions of study NCT01388036 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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
Both
18 Years to 50 Years
Yes
Contact: Mordechai Muszkat, MD 972-2-6777111 ext 73793 muszkatm@hadassah.org.il
Israel
 
NCT01388036
397-27.05.05
No
Mordechai Muszkat, MD, Hadassah- Hebrew University Medical Center
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
July 2011

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