Try our beta test site

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by University Hospital, Ghent
Sponsor:
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00782327
First received: October 29, 2008
Last updated: June 2, 2015
Last verified: June 2015

October 29, 2008
June 2, 2015
June 2009
December 2015   (Final data collection date for primary outcome measure)
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 ]
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 6 months, 1, 2 and 3 years follow-up ]
Complete list of historical versions of study NCT00782327 on ClinicalTrials.gov Archive Site
  • Comparative arterial stiffness [ Time Frame: At baseline and after 6 months, 1, 2 and 3 years follow-up ]
  • Evaluation of progression of aortic regurgitation [ Time Frame: At baseline and after 6 months, 1, 2 and 3 years follow-up ]
  • Aortic dissection incidence [ Time Frame: At baseline and after 6 months, 1, 2 and 3 years follow-up ]
  • Aortic root surgery [ Time Frame: At baseline and after 6 months, 1, 2 and 3 years follow-up ]
  • Progression of mitral regurgitation [ Time Frame: At baseline and after 6 months, 1, 2 and 3 years follow-up ]
  • Left ventricular size and function [ Time Frame: At baseline and after 6 months, 1, 2 and 3 years follow-up ]
  • Skeletal and somatic traits [ Time Frame: At baseline and after 6 months, 1, 2 and 3 years follow-up ]
  • Quality of life [ Time Frame: At baseline and after 6 months, 1, 2 and 3 years follow-up ]
  • Genetic polymorphisms affecting clinical symptoms and response to treatment [ Time Frame: End of study ]
  • Death [ Time Frame: At baseline and after 6 months, 1, 2 and 3 years follow-up ]
  • Aortic stiffness as assessed by MRI [ Time Frame: At baseline and after 1 year and 3 years follow-up ]
  • Comparative arterial stiffness [ Time Frame: At 6 months, 1, 2 and 3 years follow-up ]
  • Evaluation of progression of aortic regurgitation [ Time Frame: At 6 months, 1, 2 and 3 years follow-up ]
  • Aortic dissection incidence [ Time Frame: At 6 months, 1, 2 and 3 years follow-up ]
  • Aortic root surgery [ Time Frame: At 6 months, 1, 2 and 3 years follow-up ]
  • Progression of mitral regurgitation [ Time Frame: At 6 months, 1, 2 and 3 years follow-up ]
  • Left ventricular size and function [ Time Frame: At 6 months, 1, 2 and 3 years follow-up ]
  • Skeletal and somatic traits [ Time Frame: At 6 months, 1, 2 and 3 years follow-up ]
  • Quality of life [ Time Frame: At 6 months, 1, 2 and 3 years follow-up ]
  • Genetic polymorphisms affecting clinical symptoms and response to treatment [ Time Frame: End of study ]
  • Death [ Time Frame: At 6 months, 1, 2 and 3 years follow-up ]
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Marfan Syndrome
  • Drug: Losartan
    Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg
  • Drug: Placebo
    Daily placebo capsule
  • Experimental: 1
    Losartan
    Intervention: Drug: Losartan
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
174
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years and older   (Child, Adult, Senior)
No
Contact: Sylvia De Nobele sylvia.denobele@ugent.be
Belgium
 
 
NCT00782327
2008/503
Yes
Not Provided
Not Provided
Not Provided
University Hospital, Ghent
University Hospital, Ghent
Agentschap voor Innovatie door Wetenschap en Technologie
Principal Investigator: Julie De Backer, MD, PhD University Hospital, Ghent
University Hospital, Ghent
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP