Randomized, double-blind study for the evaluation of the effect of losartan versus placebo on aortic root dilatation in patients with Marfan syndrome under treatment with beta-blockers.

Conditions: Marfan syndrome
MedDRA version: 9.1Level: LLTClassification code 10026829Term: Marfan's syndrome

Registration Number: EUCTR2007-005862-10-BE

Lead Sponsor: niversity Hospital Ghent

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Patients > 10 years
• Diagnosis of MFS, according to the Ghent criteria and/or genetically proven FBN1 mutations or linkage
• Consent obtained (written) either for the patient and for his/her parents (<18y)
• Z-score of the aorta at the level of the sinus of Valsalva =2 (BSA adjusted)
• ARB naïve patients

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Poor echocardiographic window, limiting the accurate measurement of the aortic root
• Contra-indication for ARB:
- Bilateral renal artery stenosis, renal function abnormalities (creatinine above normal for age), hyperkalemia
- Intolerance for ARB (eg angioedema)
• Pregnancy or breast feeding women
• Absence of effective contraception
• Liver function abnormalities
• Heart Failure
• Patients included in other clinical trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the effect of losartan (an angiotensin receptor blocker -ARB) on aortic root growth in patients with Marfan syndrome, already treated with beta-blockers (BB). ;Secondary Objective: ;Primary end point(s): The decrease of rate of aortic root growth measured by echocardiography at the level of sinuses of Valsalva. The measure will be expressed in mm of growth per year and as Z-score.

Secondary Outcome Measures