Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol

Hypertension Clinical Trial

— CHAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939509
• Other study ID #: 1445
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2012
• Last updated: December 4, 2014
• Start date: February 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Atenolol
Crossover (atenolol 25-50 mg, bisoprolol 2.5-5 mg)
• Bisoprolol

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central blood pressure		two months	No
Secondary	peripheral resistance		two months	No
Secondary	cardiac index		two months	No
Secondary	pulse wave velocity		two months	No