Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

Marfan Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485368
• Other study ID #: 3/03
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2007
• Last updated: June 12, 2007
• Start date: January 2004
• Est. completion date: September 2006

Study information

• Verified date: June 2007
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Marfan Syndrome
• Syndrome

Intervention

Drug:
• Coversyl (perindopril)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Bayside Health	Baker Heart Research Institute, The Alfred

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aortic root diameter		24 weeks
Secondary	arterial stiffness		24 weeks