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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 28 February 2019
Main ID:  EUCTR2010-019302-16-GB
Date of registration: 17/08/2010
Prospective Registration: Yes
Primary sponsor: Royal Brompton and Harefield NHS Foundation Trust
Public title: A prospective, randomised, placebo-controlled, double blind, multi-centre study of the effects of Irbesartan on aortic dilatation in Marfan syndrome
Scientific title: A prospective, randomised, placebo-controlled, double blind, multi-centre study of the effects of Irbesartan on aortic dilatation in Marfan syndrome - The AIMS Study
Date of first enrolment: 13/09/2010
Target sample size: 490
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019302-16
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
United Kingdom
Contacts
Name: Regualtory Compliance Manager   
Address:  Sydney Street SW3 6NP London United Kingdom
Telephone: +4402073581218109
Email: i.jakupovic@rbht.nhs.uk
Affiliation:  Royal Brompton Hospital
Name: Regualtory Compliance Manager   
Address:  Sydney Street SW3 6NP London United Kingdom
Telephone: +4402073581218109
Email: i.jakupovic@rbht.nhs.uk
Affiliation:  Royal Brompton Hospital
Key inclusion & exclusion criteria
Inclusion criteria:
1. Clinically confirmed MFS using the Ghent diagnostic criteria
2. 2. Aorta dilated above the 95% normal confidence limits (using accepted methods)
3. Provision of informed consent
4. From 6 = to = 40 years of age inclusive

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Previous cardiac or aortic surgery
2. Planned cardiac or aortic surgery at the time of randomisation
3. Aortic diameter >=4.5cm
4. Haemodynamically significant, severe valvular disease (at the judgement of the treating clinician)
5. Heart failure, defined as left ventricular ejection fraction < 40%
6. Therapeutic use of ACE inhibitors/angiotensin-II receptor antagonist
7. Previous recorded adverse reaction to the trial medication (Irbesartan) or any ACE inhibitor/angiotensin-II receptor antagonist
8. Female patients who are pregnant, planning pregnancy or not using reliable contraception
9. Impaired renal function defined as estimated creatinine clearance <60ml/minute, or serum creatinine >150micromol/litre


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Marfan Syndrome
Intervention(s)

Trade Name: Aprovel
Product Name: Aprovel
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Irbesartan
CAS Number: 138402-11-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
INN or Proposed INN: Irbesartan
CAS Number: 138402-11-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
INN or Proposed INN: Irbesartan
CAS Number: 138402-11-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Secondary Objective: • Change in z score per year, where the z score is calculated on aortic root and body surface area (BSA).
• Clinical events and requirement for surgery including aortic dissection confirmed on TOE, MRI or CT, aortic dissection requiring emergency surgery, aortic dissection requiring elective surgery, aortic dilatation requiring elective or emergency surgery, death (all cause and classified by suspected cause), cerebrovascular accident, cardiovascular death, aortic regurgitation requiring surgery, death during surgery for any of the above.
• Left ventricular function determined by volumes and ejection fraction.
• Left ventricular mass measurements.
• Assessment of valvular function.
• Cardiac rhythm and voltage
• Height, weight, arm span and lower segment measurements.
• Fibrillin-1 mutation analysis will be performed in those patients whose mutation status is unknown.
Primary end point(s): The primary outcome measure will be the absolute change in aortic root diameter per year measured by echocardiography. Echo measurements will be taken by transthoracic echocardiograms performed at baseline and annually thereafter in order to assess the annual change of aortic dilatation.
Main Objective: Does the angiotensin II receptor antagonist, Irbesartan, reduce the rate of aortic dilatation in patients with Marfan Syndrome compared to placebo?
Secondary Outcome(s)
Secondary ID(s)
ISRCTN90011794
2010GU001B
Source(s) of Monetary Support
British Heart Foundation
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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