Condition category
Not Applicable
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
04/03/2016
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

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

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

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

Publication citations

Additional files

Editorial Notes

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