The effects of angiotensin 2 blockade on arterial stiffness in patients with Marfan Syndrome: a comparison with beta blockade and placebo (BETA BLOCKER)

ISRCTN	ISRCTN82800078
DOI	https://doi.org/10.1186/ISRCTN82800078
Secondary identifying numbers	N0544125986

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 20/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

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

Prof Morris J Brown
Scientific

Queen Mary University of London
Mile End Road
London
E1 4NS
United Kingdom

Phone	+44 20 7882 5555
Email	morris.brown@qmul.ac.uk

Study information

Study design	Randomised placebo controlled crossover group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	The effects of angiotensin 2 blockade on arterial stiffness in patients with Marfan Syndrome: a comparison with beta blockade and placebo (BETA BLOCKER)
Study objectives	Do angiotensin 2 antagonists reduce arterial stiffness in patients with Marfan Syndrome when compared to patients taking beta blockade or placebo.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Marfan syndrome
Intervention	Patients with Marfan Syndrome (MFS) develop dissection of the aorta and aortic valve incompetence which can lead to premature death. Administration of beta adrenoceptor blockers slows aortic dilation and in one study reduced the number of cardiovascular events when compared to placebo. In the light of new trial evidence and some in vitro experimentation it is possible that a new class of drug, the angiotensin 2 antagonist may have an superior benefit to the beta blocker in these patients. We aim to test this hypothesis by administering this drug in the setting of a clinical trial and measuring the response using detailed arterial stiffness measurements. In this way we hope to compare the beta blocker to the angiotensin 2 antagonist. This may subsequently form the basis for a larger multicentre trial. Cross-over design comparing beta blocker + angiotensin 2 or placebo
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	21/03/2003
Completion date	20/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	30 Years
Sex	Both
Target number of participants	30
Key inclusion criteria	30 patients aged 18-30
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	21/03/2003
Date of final enrolment	20/03/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Box No 110

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Research organisation

Cambridge Consortium - Addenbrookes (UK)

No information available

Results and Publications

Intention to publish date
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

Editorial Notes

19/04/2018: No publications found, study status unverified.
4/03/2016: No publications found, verifying study status with principal investigator.