Genetic Determinants of Hemodynamic Response to Esmolol

NCT ID: NCT01388036

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Decrease in Heart Rate Below Baseline Value

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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esmolol infusion

infusion of esmolol during rest and exercise

Group Type EXPERIMENTAL

esmolol

Intervention Type DRUG

consecutive infusions of esmolol and normal saline (placebo)

Interventions

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esmolol

consecutive infusions of esmolol and normal saline (placebo)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah- Hebrew University Medical Center

Locations

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Hadassah Hebrew University Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Mordechai Muszkat, MD

Role: CONTACT

972-2-6777111 ext. 73793

Facility Contacts

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Mordechai Muszkat, MD

Role: primary

972-2-6777111 ext. 73793

References

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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.

Reference Type DERIVED
PMID: 23114278 (View on PubMed)

Other Identifiers

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397-27.05.05

Identifier Type: -

Identifier Source: org_study_id

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