NCT00485368

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2004

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
Last Updated

June 13, 2007

Status Verified

June 1, 2007

First QC Date

June 11, 2007

Last Update Submit

June 12, 2007

Conditions

Marfan Syndrome

Keywords

marfan syndromeaortic root diameter

Outcome Measures

Primary Outcomes (1)

  • aortic root diameter

    24 weeks

Secondary Outcomes (1)

  • arterial stiffness

    24 weeks

Interventions

Coversyl (perindopril)DRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40
  • Diagnosis of Marfan Syndrome, on the basis of the Ghent Criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17911499DERIVED

MeSH Terms

Conditions

Marfan Syndrome

Interventions

Perindopril

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bronwyn A Kingwell, PhD

    Baker Heart Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 13, 2007

Study Start

January 1, 2004

Study Completion

September 1, 2006

Last Updated

June 13, 2007

Record last verified: 2007-06