- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01939509
Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol (CHAB)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Study Director: Gabriel D Waisman, MD, Hospital Italiano de Buenos Aires
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Insulin Resistance
- Hyperinsulinism
- Metabolic Syndrome
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Bisoprolol
- Atenolol
Other Study ID Numbers
- 1445
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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