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Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol (CHAB)

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ClinicalTrials.gov Identifier: NCT01939509
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Lucas Aparicio, Hospital Italiano de Buenos Aires

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.


Condition or disease Intervention/treatment Phase
Hypertension Metabolic Syndrome Drug: Atenolol Drug: Bisoprolol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparison of the Hemodynamic Changes in Patients Under Treatment With Bisoprolol Versus Atenolol
Study Start Date : February 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atenolol-Bisoprolol Drug: Atenolol
Crossover (atenolol 25-50 mg, bisoprolol 2.5-5 mg)

Drug: Bisoprolol



Primary Outcome Measures :
  1. central blood pressure [ Time Frame: two months ]

Secondary Outcome Measures :
  1. peripheral resistance [ Time Frame: two months ]
  2. cardiac index [ Time Frame: two months ]
  3. pulse wave velocity [ Time Frame: two months ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939509


Locations
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Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1181ACH
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, c118ach
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Study Director: Gabriel D Waisman, MD Hospital Italiano de Buenos Aires

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Responsible Party: Lucas Aparicio, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01939509     History of Changes
Other Study ID Numbers: 1445
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Atenolol
Bisoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action