- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01388036
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mordechai Muszkat, MD
- Phone Number: 73793 972-2-6777111
- Email: muszkatm@hadassah.org.il
Study Locations
-
-
-
Jerusalem, Israel, 91120
- Recruiting
- Hadassah Hebrew University Medical Center
-
Principal Investigator:
- Mordechai Muszkat, MD
-
Contact:
- Mordechai Muszkat, MD
- Phone Number: 73793 972-2-6777111
- Email: muszkatm@hadassah.org.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: esmolol infusion
infusion of esmolol during rest and exercise
|
consecutive infusions of esmolol and normal saline (placebo)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in heart rate during exercise
Time Frame: 3 hours
|
continous measurement of heart rate
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in systolic blood pressure during exercise
Time Frame: 3 hours
|
measurement of systolic blood pressure every 5 minutes
|
3 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Bradycardia
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Adrenergic beta-1 Receptor Antagonists
- Esmolol
Other Study ID Numbers
- 397-27.05.05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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