Effect of beta blockers on haemodynamics and brain natriuretic peptide (BNP)
ISRCTN | ISRCTN61358972 |
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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
Scientific
Clinical Pharmacology Unit
Level 3, ACCI
Box 110
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
Phone | +44 01223-336806 |
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ibw20@cam.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | Do 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) studied | 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 |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 14/05/2002 |
Completion date | 13/05/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 55 Years |
Sex | Not Specified |
Target number of participants | 20 |
Key inclusion criteria | 20 subjects in the age range of 18-55 years. |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 14/05/2002 |
Date of final enrolment | 13/05/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Pharmacology Unit
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
Cambridge Consortium - Addenbrooke's (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |