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Completed

NCT Number: NCT00782327

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

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

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Key information

Conditions

Marfan Syndrome Abnormalities, Multiple Bone Diseases Bone Diseases, Developmental Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Musculoskeletal Diseases Skin and Connective Tissue Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan

Drug

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

Placebo

Drug

Daily placebo capsule

Primary outcomes

  1. The decrease of rate of aortic root growth measured by echocardiography at level of sinuses of Valsalva. The measure will be expressed in mm of growth per year and as Z-score.

    Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up

Secondary outcomes

  1. Comparative arterial stiffness

    Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up

  2. Evaluation of progression of aortic regurgitation

    Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up

  3. Aortic dissection incidence

    Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up

  4. Aortic root surgery

    Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up

  5. Progression of mitral regurgitation

    Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up

  6. Left ventricular size and function

    Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up

  7. Skeletal and somatic traits

    Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up

  8. Quality of life

    Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up

  9. Genetic polymorphisms affecting clinical symptoms and response to treatment

    Time frame: End of study

  10. Death

    Time frame: At baseline and after 6 months, 1, 2 and 3 years follow-up

  11. Aortic stiffness as assessed by MRI

    Time frame: At baseline and after 1 year and 3 years follow-up

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 31, 2008
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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