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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
Hospital Italiano de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 1, 2012
Last Updated
December 4, 2014
Sponsor
Hospital Italiano de Buenos Aires
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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

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Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol

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