Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

June 11, 2007

Last Updated Date

June 12, 2007

Start Date ^ICMJE

January 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

aortic root diameter [ Time Frame: 24 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00485368 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

arterial stiffness [ Time Frame: 24 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

Official Title ^ICMJE

The Effect of an Angiotensin Converting Enzyme Inhibitor on Aortic Wall Properties in Patients With Marfan Syndrome.

Brief Summary

The purpose of this research is to assess the effects of a drug called perindopril on the aorta in people known to have Marfan Syndrome. The aorta is the major artery of the body that comes out of the heart and supplies blood to the body. We know that in people with Marfan Syndrome, the aorta is stiff and this stiffness results in its enlargement over many years. This enlargement of the aorta can be very serious. We know from treatment of other heart conditions that drugs of the same type as perindopril reduce stiffness of the arteries. This type of drug has never been tried in people with Marfan Syndrome.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Marfan Syndrome

Intervention ^ICMJE

Drug: Coversyl (perindopril)

Study Arms / Comparison Groups

Publications *

Ahimastos AA, Aggarwal A, D'Orsa KM, Formosa MF, White AJ, Savarirayan R, Dart AM, Kingwell BA. Effect of perindopril on large artery stiffness and aortic root diameter in patients with Marfan syndrome: a randomized controlled trial. JAMA. 2007 Oct 3;298(13):1539-47.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 18-40
Diagnosis of Marfan Syndrome, on the basis of the Ghent Criteria

Exclusion Criteria:

Age <18, >40
Women of child-bearing potential not on adequate contraception
Serum creatinine of >0.11
A history of intolerance to ACEI
Patients on angiotensin receptor blockers
Blood pressure >140/90mmHg
History of previous aortic surgery

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00485368

Responsible Party

Study ID Numbers ^ICMJE

3/03

Study Sponsor ^ICMJE

Bayside Health

Collaborators ^ICMJE

Baker Heart Research Institute
The Alfred

Investigators ^ICMJE

Principal Investigator:

Bronwyn A Kingwell, PhD

Baker Heart Research Institute

Information Provided By

Bayside Health

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP