Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

This study has been completed.

First Received on June 11, 2007. Last Updated on June 12, 2007 History of Changes

Sponsor:	Bayside Health
Collaborators:	Baker Heart Research Institute The Alfred
Information provided by:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00485368

Purpose

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.

Condition	Intervention	Phase
Marfan Syndrome	Drug: Coversyl (perindopril)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	The Effect of an Angiotensin Converting Enzyme Inhibitor on Aortic Wall Properties in Patients With Marfan Syndrome.

Resource links provided by NLM:

Genetics Home Reference related topics: Marfan syndrome

MedlinePlus related topics: Marfan Syndrome

Drug Information available for: Perindopril Perindopril erbumine

U.S. FDA Resources

Further study details as provided by Bayside Health:

Primary Outcome Measures:

aortic root diameter [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

arterial stiffness [ Time Frame: 24 weeks ]

Enrollment:	17
Study Start Date:	January 2004
Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485368

Sponsors and Collaborators

Bayside Health

Baker Heart Research Institute

The Alfred

Investigators

Principal Investigator:

Bronwyn A Kingwell, PhD

Baker Heart Research Institute

More Information

No publications provided by Bayside Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00485368 History of Changes
Other Study ID Numbers:	3/03
Study First Received:	June 11, 2007
Last Updated:	June 12, 2007
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bayside Health:

marfan syndrome
aortic root diameter

Additional relevant MeSH terms:

Marfan Syndrome
Arachnodactyly
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn

Connective Tissue Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Angiotensin-Converting Enzyme Inhibitors
Perindopril
Enzyme Inhibitors
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012