Trial record 3 of 23 for:    "Marfan syndrome"

Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

This study has been completed.
Sponsor:
Collaborators:
Baker Heart Research Institute
The Alfred
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00485368
First received: June 11, 2007
Last updated: June 12, 2007
Last verified: June 2007
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Syndrome
Disease
Pathologic Processes
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
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014