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Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

Primary Purpose

Marfan Syndrome

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Coversyl (perindopril)

About this trial

This is an interventional prevention trial for Marfan Syndrome focused on measuring marfan syndrome, aortic root diameter

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

aortic root diameter

Secondary Outcome Measures

arterial stiffness

Full Information

NCT ID

NCT00485368

First Posted

June 11, 2007

Last Updated

June 12, 2007

Sponsor

Bayside Health

Collaborators

Baker Heart Research Institute, The Alfred

1. Study Identification

Unique Protocol Identification Number

NCT00485368

Brief Title

Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bayside Health

Collaborators

Baker Heart Research Institute, The Alfred

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Marfan Syndrome

Keywords

marfan syndrome, aortic root diameter

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Coversyl (perindopril)

Primary Outcome Measure Information:

Title

aortic root diameter

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

arterial stiffness

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bronwyn A Kingwell, PhD

Organizational Affiliation

Baker Heart Research Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

17911499

Citation

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. doi: 10.1001/jama.298.13.1539.

Results Reference

derived

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Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

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