Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
08/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ian B Wilkinson

ORCID ID

Contact details

Clinical Pharmacology Unit
Level 3
ACCI
Box 110
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 01223-336806
ibw20@cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544112292

Study information

Scientific title

Acronym

Study hypothesis

Do different beta blockers have variant effects on arterial stiffness and central blood pressure?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular: Hypertension

Intervention

The aim of the study is to test the effects of Atenolol, Pindolol and Nebivolol on central blood pressure and augmentation index. Studies of normotensive and hypertensive individuals have confirmed that pulse pressure is a better predictor of cardiovascular events than mean pressure in older adults.
There is evidence that the traditional beta blocker Atenolol is less effective in reducing strokes and also lowering central blood pressure and augmentation index. This may be due to a direct arterial stiffening effect but also partly due to a fall in heart rate. However, Nebivolol is much more beta 1 selective than Atenolol and also causes vasodilatation by releasing NO which may in turn have additional benefits with regard to augmentation index and central blood pressure.

At visit 1 there will be a physical examination, blood pressure measurements, blood tests and measurements of arterial stiffness using a small sensor placed in turn against the skin on the arm and neck. The patients will be asked about their general medical history to ensure that it is safe for them to take part in the study.

Patients will be randomised prior to commencement. Patients will them be given a single dose of either Atenolol 50 mg, Nebivolol 5 mg, Pindolol 5 mg, a placebo. Repeat measurements will be taken after 1, 2 and 4 h.

Patients will return 1 week later for visit 2 when repeat measurements as for visit 1 will be performed and different medication given. As at visit 1 measurements will be taken after 1, 2 and 4 h.

Patients will then be asked to return for visits 3 and 4 after an interval of 1 week between each visit. All measurements as for visit 1 and 2 will be repeated and randomised medication given.

Each visit will last for approximately 5 h.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

14/05/2002

Overall trial end date

13/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

20 subjects in the age range of 18-55 years.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

14/05/2002

Recruitment end date

13/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Pharmacology Unit
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Not published

Publication citations

Additional files

Editorial Notes