Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00782327
Other study ID # 2008/503
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 1, 2009
Est. completion date November 26, 2014

Study information

Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date November 26, 2014
Est. primary completion date November 26, 2014
Accepts healthy volunteers No
Gender All
Age group 10 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Ghent Agentschap voor Innovatie door Wetenschap en Technologie

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At baseline and after 6 months, 1, 2 and 3 years follow-up
Secondary Comparative arterial stiffness At baseline and after 6 months, 1, 2 and 3 years follow-up
Secondary Evaluation of progression of aortic regurgitation At baseline and after 6 months, 1, 2 and 3 years follow-up
Secondary Aortic dissection incidence At baseline and after 6 months, 1, 2 and 3 years follow-up
Secondary Aortic root surgery At baseline and after 6 months, 1, 2 and 3 years follow-up
Secondary Progression of mitral regurgitation At baseline and after 6 months, 1, 2 and 3 years follow-up
Secondary Left ventricular size and function At baseline and after 6 months, 1, 2 and 3 years follow-up
Secondary Skeletal and somatic traits At baseline and after 6 months, 1, 2 and 3 years follow-up
Secondary Quality of life At baseline and after 6 months, 1, 2 and 3 years follow-up
Secondary Genetic polymorphisms affecting clinical symptoms and response to treatment End of study
Secondary Death At baseline and after 6 months, 1, 2 and 3 years follow-up
Secondary Aortic stiffness as assessed by MRI At baseline and after 1 year and 3 years follow-up
See also
  Status Clinical Trial Phase
Terminated NCT00763893 - Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome Phase 3
Recruiting NCT05809323 - Marfan Syndrome Moderate Exercise Trial II N/A
Completed NCT04776668 - Living With Marfan Syndrome and Your Aorta
Recruiting NCT01949233 - The Oxford Marfan Trial Phase 2
Active, not recruiting NCT01145612 - Atenolol Versus Losartan in the Prevention of Progressive Dilation of the Aorta in Marfan Syndrome Phase 3
Completed NCT00723801 - Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome Phase 3
Completed NCT04641325 - Marfan Syndrome Moderate Exercise Pilot N/A
Recruiting NCT06257004 - Genome-wide Epistasis for Cardiovascular Severity in Marfan Study
Completed NCT01322165 - National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions N/A
Recruiting NCT05700175 - Transcriptomic Study of Adult Population With Marfan Syndrome
Not yet recruiting NCT05838235 - Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Marfan Syndrome N/A
Recruiting NCT02148900 - Development of a Blood Test for Marfan Syndrome N/A
Active, not recruiting NCT05980104 - Single-Session "Empowered Relief" Class for Marfan Syndrome and Related Conditions N/A
Recruiting NCT02050113 - Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices N/A
Completed NCT00001641 - Study of Heritable Connective Tissue Disorders N/A
Completed NCT01715207 - Comparison Study of the Effect of Aliskiren Versus Negative Controls on Aortic Stiffness in Patients With Marfan Syndrome Under Treatment With Atenolol Phase 3
Completed NCT05516043 - Safety and Performance of POLYTHESE® Vascular Prosthesis
Recruiting NCT04776681 - Living With Marfans and Your Aorta: Surgical Outcomes Study
Completed NCT03236571 - Cardiorespiratory and Muscular Rehabilitation of Children and Young Adults With Marfan Syndrome. N/A
Recruiting NCT00683124 - Nebivolol Versus Losartan Versus Nebivolol+Losartan Against Aortic Root Dilation in Genotyped Marfan Patients Phase 3