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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
Information provided by:
Hadassah Medical Organization Identifier:
First received: July 3, 2011
Last updated: July 5, 2011
Last verified: July 2011

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 Intervention
Decrease in Heart Rate Below Baseline Value Drug: esmolol

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

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

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

Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: esmolol infusion
infusion of esmolol during rest and exercise
Drug: esmolol
consecutive infusions of esmolol and normal saline (placebo)


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01388036

Contact: Mordechai Muszkat, MD 972-2-6777111 ext 73793

Hadassah Hebrew University Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Mordechai Muszkat, MD    972-2-6777111 ext 73793   
Principal Investigator: Mordechai Muszkat, MD         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mordechai Muszkat, MD, Hadassah- Hebrew University Medical Center Identifier: NCT01388036     History of Changes
Other Study ID Numbers: 397-27.05.05
Study First Received: July 3, 2011
Last Updated: July 5, 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 processed this record on September 21, 2017