The effects of irbesartan on aortic dilatation in Marfan's syndrome

Phase 3

Completed

• Conditions: Marfan's syndrome; Not Applicable; Other specified congenital malformation syndromes affecting multiple systems

• Registration Number: ISRCTN90011794
• Lead Sponsor: Royal Brompton and Harefield NHS Foundation Trust (UK)

Brief Summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/24289736 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31836196 (added 16/12/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-06
• Study Completion: 2017-03-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

1. Clinically confirmed Marfan's syndrome
2. Aorta dilated above the normal 95th percentile
3. Greater than 6 and less than 40 years of age, either sex
4. Provision of informed consent

Exclusion Criteria

1. Previous cardiac or aortic surgery
2. Planned cardiac or aortic surgery
3. Aortic diameter greater than or equal to 4.5 cm
4. Haemodynamically significant, severe valvular disease
5. Heart failure (defined as left ventricular ejection fraction [LVEF] less than 40%)
6. Therapeutic use of angiotensin converting enzyme (ACE) inhibitors/angiotensin-II receptor antagonist
7. Previous recorded adverse reaction to the trial medication (irbesartan)
8. Female patient who is pregnant, planning pregnancy or not using reliable contraception
9. Impaired renal function

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute change in aortic root diameter per year measured by echocardiography