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| Sponsor: | National Taiwan University Hospital |
|---|---|
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00651235 |
Purpose
To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive dilation of aortic root in patients with Marfan syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Marfan Syndrome |
Drug: Losartan and Atenolol or Propranolol Drug: Atenolol or Propranolol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-Label, Active Control Trial to Evaluate the Effect of LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome |
| Estimated Enrollment: | 44 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
B: Experimental
In combination therapy,the maximal dose of Losartan is 100 mg/day for adult and 50 mg/day for children. 50 mg of Atenolol once daily, 20 mg of Propranolol twice daily for adult and 1 mg/Kg/day for children
|
Drug: Losartan and Atenolol or Propranolol
50 mg of Atenolol once daily, 20 mg of Propranolol twice daily for adult and 1 mg/Kg/day for children. Losartan is 100 mg/day for adult and 50 mg/day for children. |
|
A: Active Comparator
The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
|
Drug: Atenolol or Propranolol
The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
|
Marfan syndrome (MFS) is a multisystem connective tissue disorder of autosomal dominant inheritance1. The cardinal features are noted in the cardiovascular, ocular, and skeletal system. The most life-threatening complication of MFS is progressive aortic root dilation leading to aortic dissection or rupture. Losartan, an angiotensin II type I receptor (AT1) antagonist, is a drug already in clinical use for hypertension and type II diabetic nephropathy. A recent study showed that Losartan prevents aortic root dilation and lung problem in a mouse model of MFS. Therefore, the goals of this clinical trial are to examine the efficacy and safety of Losartan in patients with Marfan syndrome for aortic root dilation prevention.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Contacts and Locations More Information
| Responsible Party: | National Taiwan University Hospital ( Mei -Hwan Wu ) |
| Study ID Numbers: | 200610030M |
| Study First Received: | March 3, 2008 |
| Last Updated: | April 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00651235 History of Changes |
| Health Authority: | Taiwan: Department of Health |
|
Vasodilator Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Bone Diseases Musculoskeletal Abnormalities Limb Deformities, Congenital Pathologic Processes Musculoskeletal Diseases Propranolol Syndrome Therapeutic Uses Abnormalities, Multiple Bone Diseases, Developmental |
Connective Tissue Diseases Adrenergic beta-Antagonists Cardiovascular Diseases Anti-Arrhythmia Agents Congenital Abnormalities Sympatholytics Losartan Heart Diseases Disease Cardiovascular Abnormalities Cardiovascular Agents Marfan Syndrome Antihypertensive Agents Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers |
