Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Agentschap voor Innovatie door Wetenschap en Technologie | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Losartan |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative arterial stiffness | At baseline and after 6 months, 1, 2 and 3 years follow-up | |
| Evaluation of progression of aortic regurgitation | At baseline and after 6 months, 1, 2 and 3 years follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julie De Backer, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
Not provided
| Label | URL |
|---|---|
| Website of the University Hospital Ghent | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Daily placebo capsule |
|
| Aortic dissection incidence | At baseline and after 6 months, 1, 2 and 3 years follow-up |
| Aortic root surgery | At baseline and after 6 months, 1, 2 and 3 years follow-up |
| Progression of mitral regurgitation | At baseline and after 6 months, 1, 2 and 3 years follow-up |
| Left ventricular size and function | At baseline and after 6 months, 1, 2 and 3 years follow-up |
| Skeletal and somatic traits | At baseline and after 6 months, 1, 2 and 3 years follow-up |
| Quality of life | At baseline and after 6 months, 1, 2 and 3 years follow-up |
| Genetic polymorphisms affecting clinical symptoms and response to treatment | End of study |
| Death | At baseline and after 6 months, 1, 2 and 3 years follow-up |
| Aortic stiffness as assessed by MRI | At baseline and after 1 year and 3 years follow-up |
| ID | Term |
|---|---|
| D008382 | Marfan Syndrome |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
Not provided
Not provided