Contact information
Type
Scientific
Primary contact
Prof Morris J Brown
ORCID ID
Contact details
Queen Mary University of London
Mile End Road
London
E1 4NS
United Kingdom
+44 20 7882 5555
morris.brown@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0544129339
Study information
Scientific title
The effects of angiotensin 2 blockade and long acting nitrates on arterial stiffness in patients with Marfan Syndrome. A placebo controlled study (NITRATES)
Acronym
Study hypothesis
Angiotensin 2 antagonists and nitrates reduce arterial stiffness in patients with Marfan Syndrome.
Ethics approval
Not provided at time of registration
Study design
Randomised placebo controlled crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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 dissection 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 other classes of drug, the angiotensin 2 antagonist and the nitrates may have a superior benefit to the beta blocker in these patients. We aim to test this hypothesis by administering these drugs in the setting of a clinical trial and measuring the response using detailed arterial stiffness measurements. In this way we hope to compare the nitrate to the angiotensin 2 antagonist and placebo. This may subsequently form the basis for a larger multi centre trial.
Cross-over design comparing nitrates + angiotensin or placebo.
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
23/06/2003
Overall trial end date
22/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
30 subjects aged 18-30
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
30
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
23/06/2003
Recruitment end date
22/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Box No 110
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research organisation
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