NCT01388036

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

July 6, 2011

Status Verified

July 1, 2011

Enrollment Period

3.8 years

First QC Date

July 3, 2011

Last Update Submit

July 5, 2011

Conditions

Decrease in Heart Rate Below Baseline Value

Keywords

heart rate

Outcome Measures

Primary Outcomes (1)

  • Change in heart rate during exercise

    continous measurement of heart rate

    3 hours

Secondary Outcomes (1)

  • change in systolic blood pressure during exercise

    3 hours

Study Arms (1)

esmolol infusion

EXPERIMENTAL

infusion of esmolol during rest and exercise

Drug: esmolol

Interventions

esmololDRUG

consecutive infusions of esmolol and normal saline (placebo)

esmolol infusion

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male and female
  • able to understand and sign informed consent

You may not qualify if:

  • consumption of any medication
  • bradycardia \<50 BPM
  • hypersensitivity to beta blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23114278DERIVED

MeSH Terms

Interventions

esmolol

Central Study Contacts

Mordechai Muszkat, MD

CONTACT

972-2-6777111muszkatm@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2011

First Posted

July 6, 2011

Study Start

July 1, 2011

Primary Completion

May 1, 2015

Last Updated

July 6, 2011

Record last verified: 2011-07

Locations

IL(1)