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

A prospective, randomised, placebo-controlled double blind, multicentre study of the effects of irbesartan on aortic dilatation in Marfan's syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90011794

Enrollment

490

Registered

2010-04-06

Start date

2010-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marfan's syndrome Not Applicable Other specified congenital malformation syndromes affecting multiple systems

Interventions

1. Run in Phase: 75 mg open label irbesartan (1 month) - all patients 2. Month 2: 150 mg irbesartan/placebo once daily (o.d.) 3. Months 3 - 48: 300 mg irbesartan/pla

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Absolute change in aortic root diameter per year measured by echocardiography	—

Secondary

Measure	Time frame
1. Change in z score per year - where the z score is calculated on aortic root and body surface area (BSA) 2. Clinical events and requirement for surgery including aortic dissection confirmed on transoesophageal echocardiography (TOE), magnetic resonance imaging (MRI) or computed tomography (CT) 3. Aortic dissection requiring emergency surgery 4. Aortic dissection requiring elective surgery 5. Aortic dilatation requiring elective or emergency surgery 6. Sudden death 7. Cerebrovascular accident 8. Cardiovascular death 9. Aortic regurgitation requiring surgery 10. Death during surgery for any of the above 11. Left ventricular function determined by volumes and ejection fraction 12. Left ventricular mass measurements 13. Assessment of valvular function 14. Cardiac rhythm and voltage 15. Height 16. Arm span and lower segment measurements 17. Fibrillin-1 mutation analysis will be performed in those patients whose mutation status is unknown All outcomes are measured annually.	—

Measure

Time frame

1. Change in z score per year - where the z score is calculated on aortic root and body surface area (BSA) 2. Clinical events and requirement for surgery including aortic dissection confirmed on transoesophageal echocardiography (TOE), magnetic resonance imaging (MRI) or computed tomography (CT) 3. Aortic dissection requiring emergency surgery 4. Aortic dissection requiring elective surgery 5. Aortic dilatation requiring elective or emergency surgery 6. Sudden death 7. Cerebrovascular accident 8. Cardiovascular death 9. Aortic regurgitation requiring surgery 10. Death during surgery for any of the above 11. Left ventricular function determined by volumes and ejection fraction 12. Left ventricular mass measurements 13. Assessment of valvular function 14. Cardiac rhythm and voltage 15. Height 16. Arm span and lower segment measurements 17. Fibrillin-1 mutation analysis will be performed in those patients whose mutation status is unknown All outcomes are measured annually.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026