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
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]
    continous measurement of heart rate


Secondary Outcome Measures:
  • change in systolic blood pressure during exercise [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
    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)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01388036

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

Locations
Israel
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
  More Information

No publications provided by Hadassah Medical Organization

Additional 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
Study First Received: July 3, 2011
Last Updated: July 5, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
heart rate

Additional relevant MeSH terms:
Esmolol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014