Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome | NCT00485368

Studies
Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

NCT00485368

Sponsor

Bayside Health

Status

Completed

Last Update Posted

Jun 13, 2007Estimated

Enrollment

17Actual

Phase

Phase 3

Conditions

Marfan Syndrome

Interventions

Coversyl (perindopril)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Sep 2006Actual

First Submitted Date

Jun 11, 2007

First Submission Date that Met QC Criteria

Jun 12, 2007

First Posted Date

Jun 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2007

Last Update Posted Date

Jun 13, 2007Estimated

Name	Class
Baker Heart Research Institute	OTHER
The Alfred	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Name	Type	Description	Arm Group Labels	Other Names
Coversyl (perindopril)	Drug

Measure	Description	Time Frame
aortic root diameter		24 weeks

Measure	Description	Time Frame
arterial stiffness		24 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bronwyn A Kingwell, PhD	Baker Heart Research Institute	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17911499	Derived	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.	26594834JAMA. 2015 Dec 22-29;314(24):2692-3

ID	Term
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006330	Heart Defects, Congenital

ID	Term
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds