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Genetic Determinants of Hemodynamic Response to Esmolol

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01388036
First Posted: July 6, 2011
Last Update Posted: July 6, 2011
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.
Information provided by:
Hadassah Medical Organization
July 3, 2011
July 6, 2011
July 6, 2011
July 2011
May 2015   (Final data collection date for primary outcome measure)
Change in heart rate during exercise [ Time Frame: 3 hours ]
continous measurement of heart rate
Same as current
No Changes Posted
change in systolic blood pressure during exercise [ Time Frame: 3 hours ]
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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01388036
397-27.05.05
No
Not Provided
Not Provided
Mordechai Muszkat, MD, Hadassah- Hebrew University Medical Center
Hadassah Medical Organization
Not Provided
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