Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol (CHAB)

December 4, 2014 updated by: Lucas Aparicio, Hospital Italiano de Buenos Aires

Comparison of the Hemodynamic Changes in Patients Under Treatment With Bisoprolol Versus Atenolol

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, c118ach
        • Hospital Italiano de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atenolol-Bisoprolol
Crossover (atenolol 25-50 mg, bisoprolol 2.5-5 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
central blood pressure
Time Frame: two months
two months

Secondary Outcome Measures

Outcome Measure
Time Frame
peripheral resistance
Time Frame: two months
two months
cardiac index
Time Frame: two months
two months
pulse wave velocity
Time Frame: two months
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gabriel D Waisman, MD, Hospital Italiano de Buenos Aires

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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