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Genetic Determinants of Hemodynamic Response to Esmolol

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ClinicalTrials.gov Identifier: NCT01388036
Recruitment Status : Unknown
Verified July 2011 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : July 6, 2011
Last Update Posted : July 6, 2011
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment
Decrease in Heart Rate Below Baseline Value Drug: esmolol

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Study in Healthy Subjects to Evaluate Genetic Determinants of the Variability in Hemodynamic Response to Esmolol
Study Start Date : July 2011
Estimated Primary Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: esmolol infusion
infusion of esmolol during rest and exercise
Drug: esmolol
consecutive infusions of esmolol and normal saline (placebo)

Primary Outcome Measures :
  1. Change in heart rate during exercise [ Time Frame: 3 hours ]
    continous measurement of heart rate

Secondary Outcome Measures :
  1. change in systolic blood pressure during exercise [ Time Frame: 3 hours ]
    measurement of systolic blood pressure every 5 minutes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388036

Contact: Mordechai Muszkat, MD 972-2-6777111 ext 73793 muszkatm@hadassah.org.il

Hadassah Hebrew University Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Mordechai Muszkat, MD    972-2-6777111 ext 73793    muszkatm@hadassah.org.il   
Principal Investigator: Mordechai Muszkat, MD         
Sponsors and Collaborators
Hadassah Medical Organization

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mordechai Muszkat, MD, Hadassah- Hebrew University Medical Center
ClinicalTrials.gov Identifier: NCT01388036     History of Changes
Other Study ID Numbers: 397-27.05.05
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: July 2011

Keywords provided by Hadassah Medical Organization:
heart rate

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs