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| Sponsor: | University of British Columbia |
|---|---|
| Collaborator: |
Heart and Stroke Foundation of Canada |
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00593710 |
Purpose
Marfan syndrome is a genetic disease of our connective tissue, which provides material and support for our skeleton, muscles, blood vessels and other parts of our bodies. People with Marfan syndrome may be tall and thin with slender, tapering fingers, long arms and legs, and spine curvature. They often have heart and eye problems. In some patients, the condition is very mild and the person has few or no symptoms. Others are always at risk of life-threatening problems, which usually involve damage to the valves in the heart or weakening of the large blood vessels leading from the heart. If the blood vessels become weak, they can balloon out (dilate) and break (rupture), which might cause the person to die suddenly. We have only a limited ability to stop the progression of disease in Marfan syndrome. Typically we use medicines that lower heart rate or blood pressure (or both). But this does not prevent the disease and very few drugs work well enough to keep patients from needing surgery or dying suddenly because a blood vessel has torn open. Our objective is to study two medicines to see if one, or both, can improve blood vessel function in patients with Marfan syndrome. One (Atenolol) belongs to a group of drugs called beta blockers and is often used to treat high blood pressure. It is the most common drug that is currently used to treat patients with Marfan syndrome. The other (Losartan) is also used for high blood pressure, but works in a different way. This study will help us to find better ways to treat people who have Marfan syndrome and to identify early changes in blood vessel function that may help to prevent long-term complications.
| Condition | Intervention | Phase |
|---|---|---|
|
Marfan Syndrome |
Drug: Losartan Drug: Atenolol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Double-Blind Study Assessing the Effects of Losartan Versus Atenolol on Pulse Wave Velocity and the Biophysical Properties of the Aorta in Patients With Marfan Syndrome |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Losartan
|
Drug: Losartan
Losartan (25mg OD)
|
|
2: Active Comparator
Atenolol
|
Drug: Atenolol
Atenolol (25-50mg OD)
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 12 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Leslie Raffin, RN | 778-388-3162 | lraffin@cw.bc.ca |
| Canada, British Columbia | |
| Children's Heart Centre, British Columbia's Children's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Leslie Raffin, RN 778-388-3162 lraffin@cw.bc.ca | |
| Principal Investigator: | George Sandor, MD, FRCPC | University of British Columbia |
| Study Director: | Cornelius van Breemen, MD | University of British Columbia |
| Study Director: | James E. Potts, MD | University of British Columbia |
More Information
| Responsible Party: | University of British Columbia ( Dr. George G.S. Sandor ) |
| Study ID Numbers: | H07-01816, 07-01816 |
| Study First Received: | January 3, 2008 |
| Last Updated: | July 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00593710 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Randomized double-blind superiority trial |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Bone Diseases Musculoskeletal Abnormalities Limb Deformities, Congenital Pathologic Processes Musculoskeletal Diseases Syndrome Therapeutic Uses Abnormalities, Multiple Bone Diseases, Developmental Connective Tissue Diseases Adrenergic beta-Antagonists |
Cardiovascular Diseases Anti-Arrhythmia Agents Congenital Abnormalities Losartan Sympatholytics Heart Diseases Disease Cardiovascular Abnormalities Cardiovascular Agents Marfan Syndrome Antihypertensive Agents Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Genetic Diseases, Inborn Autonomic Agents |