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Genetic Determinants of Hemodynamic Response to Esmolol

Primary Purpose

Decrease in Heart Rate Below Baseline Value

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

esmolol

About this trial

This is an interventional basic science trial for Decrease in Heart Rate Below Baseline Value focused on measuring heart rate

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hadassah Hebrew University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

esmolol infusion

Arm Description

infusion of esmolol during rest and exercise

Outcomes

Primary Outcome Measures

Change in heart rate during exercise

continous measurement of heart rate

Secondary Outcome Measures

change in systolic blood pressure during exercise

measurement of systolic blood pressure every 5 minutes

Full Information

NCT ID

NCT01388036

First Posted

July 3, 2011

Last Updated

July 5, 2011

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT01388036

Brief Title

Genetic Determinants of Hemodynamic Response to Esmolol

Official Title

A Study in Healthy Subjects to Evaluate Genetic Determinants of the Variability in Hemodynamic Response to Esmolol

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2011 (undefined)

Primary Completion Date

May 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Decrease in Heart Rate Below Baseline Value

Keywords

heart rate

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

esmolol infusion

Arm Type

Experimental

Arm Description

infusion of esmolol during rest and exercise

Intervention Type

Drug

Intervention Name(s)

esmolol

Intervention Description

consecutive infusions of esmolol and normal saline (placebo)

Primary Outcome Measure Information:

Title

Change in heart rate during exercise

Description

continous measurement of heart rate

Time Frame

3 hours

Secondary Outcome Measure Information:

Title

change in systolic blood pressure during exercise

Description

measurement of systolic blood pressure every 5 minutes

Time Frame

3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mordechai Muszkat, MD

Phone

972-2-6777111

Ext

73793

muszkatm@hadassah.org.il

Facility Information:

Facility Name

Hadassah Hebrew University Medical Center

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mordechai Muszkat, MD

Phone

972-2-6777111

Ext

73793

muszkatm@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Mordechai Muszkat, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23114278

Citation

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 beta(1) adrenergic receptor antagonist esmolol in healthy individuals. Pharmacogenet Genomics. 2013 Jan;23(1):25-8. doi: 10.1097/FPC.0b013e32835afde6.

Results Reference

derived

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Genetic Determinants of Hemodynamic Response to Esmolol

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