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.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2007-005862-10-BE
• Date of registration: 07/01/2009
• Prospective Registration: Yes
• Primary sponsor: University Hospital Ghent
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 29/05/2009
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005862-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Marfan syndrome
MedDRA version: 9.1 Level: LLT Classification code 10026829 Term: Marfan's syndrome

Intervention(s)

Trade Name: Cozaar
Product Name: Losartan
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Losartan potassium
CAS Number: 124750998
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Coozar
Product Name: Losartan
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Losartan potassium
CAS Number: 124750998
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Coozar
Product Name: Losartan
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Losartan potassium
CAS Number: 124750998
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

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 ID(s)

AGO/2007/011