Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

NCT ID: NCT00485368

Last Updated: 2007-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-09-30

Brief Summary

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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

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Conditions

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Marfan Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Coversyl (perindopril)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baker Heart Research Institute

OTHER

Sponsor Role collaborator

The Alfred

OTHER

Sponsor Role collaborator

Bayside Health

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Bronwyn A Kingwell, PhD

Role: PRINCIPAL_INVESTIGATOR

Baker Heart Research Institute

References

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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.

Reference Type DERIVED
PMID: 17911499 (View on PubMed)

Other Identifiers

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3/03

Identifier Type: -

Identifier Source: org_study_id