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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

NCT ID: NCT00782327

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-01

Study Completion Date

2014-11-26

Brief Summary

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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

Detailed Description

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Conditions

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Marfan Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Losartan

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

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

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily placebo capsule

Interventions

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Losartan

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

Intervention Type DRUG

Placebo

Daily placebo capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agentschap voor Innovatie door Wetenschap en Technologie

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie De Backer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2008/503

Identifier Type: -

Identifier Source: org_study_id