Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol (CHAB)
Primary Purpose
Hypertension, Metabolic Syndrome
Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Atenolol
Bisoprolol
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Hypertension
- Metabolic syndrome
Exclusion Criteria:
- Severe hypertension >180/110
- Secondary hypertension
- Contraindication for betablockers
- Prior treatment with betablockers (up to one month before inclusion)
- History of neoplastic disease
- Patients that do not sign informed consent
Sites / Locations
- Hospital Italiano de Buenos Aires
- Hospital Italiano de Buenos Aires
- Hospital Italiano de Buenos Aires
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atenolol-Bisoprolol
Arm Description
Outcomes
Primary Outcome Measures
central blood pressure
Secondary Outcome Measures
peripheral resistance
cardiac index
pulse wave velocity
Full Information
NCT ID
NCT01939509
First Posted
February 1, 2012
Last Updated
December 4, 2014
Sponsor
Hospital Italiano de Buenos Aires
1. Study Identification
Unique Protocol Identification Number
NCT01939509
Brief Title
Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol
Acronym
CHAB
Official Title
Comparison of the Hemodynamic Changes in Patients Under Treatment With Bisoprolol Versus Atenolol
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
At hemodynamic level, the greater affinity of bisoprolol by the beta 1 receptor in theory could improve the peripheral arterial perfusion and could have a greater antihypertensive effect. At the same time, this could carry objectifiable improvements in the vascular tree, such as the level of arterial stiffness.
This study attempts to mark the hemodynamic differences in the same individual with hypertension and metabolic syndrome who will be exposed to both drugs at different moments. Parameters will be objectified with impedance cardiography, pulse wave velocity and central blood pressure assessment before and after taking each one of the drugs. The results will be compared to the baseline data and between themselves.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Metabolic Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atenolol-Bisoprolol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atenolol
Intervention Description
Crossover (atenolol 25-50 mg, bisoprolol 2.5-5 mg)
Intervention Type
Drug
Intervention Name(s)
Bisoprolol
Primary Outcome Measure Information:
Title
central blood pressure
Time Frame
two months
Secondary Outcome Measure Information:
Title
peripheral resistance
Time Frame
two months
Title
cardiac index
Time Frame
two months
Title
pulse wave velocity
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hypertension
Metabolic syndrome
Exclusion Criteria:
Severe hypertension >180/110
Secondary hypertension
Contraindication for betablockers
Prior treatment with betablockers (up to one month before inclusion)
History of neoplastic disease
Patients that do not sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel D Waisman, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
c118ach
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
12. IPD Sharing Statement
Learn more about this trial
Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol
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