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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005862-10-BE
Enrollment
Unknown
Registered
2009-01-07
Start date
2009-05-29
Completion date
Unknown
Last updated
2015-07-10

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

Conditions

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

Interventions

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:

Sponsors

University Hospital Ghent
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 (=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026