NCT01939509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Feb 2012

Typical duration for phase_4 hypertension

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

2.7 years

First QC Date

February 1, 2012

Last Update Submit

December 4, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • central blood pressure

    two months

Secondary Outcomes (3)

  • peripheral resistance

    two months

  • cardiac index

    two months

  • pulse wave velocity

    two months

Study Arms (1)

Atenolol-Bisoprolol

EXPERIMENTAL
Drug: AtenololDrug: Bisoprolol

Interventions

Crossover (atenolol 25-50 mg, bisoprolol 2.5-5 mg)

Atenolol-Bisoprolol
Atenolol-Bisoprolol

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension
  • Metabolic syndrome

You may not qualify if:

  • Severe hypertension \>180/110
  • Secondary hypertension
  • Contraindication for betablockers
  • History of neoplastic disease
  • Patients that do not sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, c118ach, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

HypertensionMetabolic Syndrome

Interventions

AtenololBisoprolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Gabriel D Waisman, MD

    Hospital Italiano de Buenos Aires

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 1, 2012

First Posted

September 11, 2013

Study Start

February 1, 2012

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations