Effect of beta blockers on haemodynamics and brain natriuretic peptide (BNP)

ISRCTN ISRCTN61358972
DOI https://doi.org/10.1186/ISRCTN61358972
Secondary identifying numbers N0544112292
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
08/09/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ian B Wilkinson
Scientific

Clinical Pharmacology Unit
Level 3, ACCI
Box 110
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Phone +44 01223-336806
Email ibw20@cam.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesDo different beta blockers have variant effects on arterial stiffness and central blood pressure?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular: Hypertension
InterventionThe 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date14/05/2002
Completion date13/05/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit55 Years
SexNot Specified
Target number of participants20
Key inclusion criteria20 subjects in the age range of 18-55 years.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment14/05/2002
Date of final enrolment13/05/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Clinical Pharmacology Unit
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Cambridge Consortium - Addenbrooke's (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan