Decrease in Heart Rate Below Baseline Value Clinical Trial
Official title:
A Study in Healthy Subjects to Evaluate Genetic Determinants of the Variability in Hemodynamic Response to Esmolol
| NCT number | NCT01388036 |
| Other study ID # | 397-27.05.05 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | July 3, 2011 |
| Last updated | July 5, 2011 |
| Start date | July 2011 |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah Hebrew University Medical Center | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in heart rate during exercise | continous measurement of heart rate | 3 hours | Yes |
| Secondary | change in systolic blood pressure during exercise | measurement of systolic blood pressure every 5 minutes | 3 hours | Yes |