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

Ghent University Hospital (UZ)

Status and phase

Completed

Phase 3

Conditions

Marfan Syndrome

Treatments

Drug: Placebo

Drug: Losartan

Study type

Interventional

Funder types

Other

Identifiers

NCT00782327

2008/503

Details and patient eligibility

About

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). The effect of losartan will be compared to placebo. Losartan or placebo will be added to the treatment regimen in a two-step up-titration scheme over 2 weeks. Start doses of Losartan will be 25 mg for subjects under 50kg of weight and 50mg if the weight is over 50kg. Uptitration will be guided by the tolerance of the drug by the patients. Patients will be contacted by phone call for assessment of side-effects before second step of uptitration.

Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg

Enrollment

22 patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

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

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