Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome - Full Text View

Sponsors and Collaborators:	Bayside Health 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

Genetics Home Reference related topics: Marfan syndrome

MedlinePlus related topics: Marfan Syndrome

Drug Information available for: Perindopril Perindopril erbumine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of an Angiotensin Converting Enzyme Inhibitor on Aortic Wall Properties in Patients With Marfan Syndrome.

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

Publications indexed to this study:

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.

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

Keywords provided by Bayside Health:

marfan syndrome
aortic root diameter

Study placed in the following topic categories:

Perindopril
Heart Diseases
Cardiovascular Abnormalities
Marfan syndrome
Marfan Syndrome
Bone Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases

Genetic Diseases, Inborn
Bone Diseases, Developmental
Abnormalities, Multiple
Connective Tissue Diseases
Congenital Abnormalities
Heart Defects, Congenital
Arachnodactyly

Additional relevant MeSH terms:

Disease
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

Limb Deformities, Congenital
Pathologic Processes
Syndrome
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009