Losartan Versus Atenolol for the Treatment of Marfan Syndrome
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
- Pulse Wave Velocity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Biophysical properties of the aorta [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Brachial artery reactivity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Aortic root dimension and area [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 17 |
| Study Start Date: | January 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Losartan
|
Drug: Losartan
Losartan (25mg OD)
|
|
Active Comparator: 2
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:
- Subjects must conform to the diagnostic criteria for MFS;
- Subjects must be between 12 and 25 years;
- Subjects must have technically suitable echocardiographic windows to obtain the images needed to calculate the biophysical properties listed as outcome measures;
- Subjects must provide informed consent and/or assent.
Exclusion Criteria:
- Patients with significant aortic or mitral valve regurgitation;
- Patients with a medical condition that would preclude them from taking either of the study medications or be taken off either medication for a brief period of time;
- Female patients who are pregnant, planning to become pregnant, or breast-feeding.
Contacts and Locations| Canada, British Columbia | |
| Children's Heart Centre, British Columbia's Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| 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
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00593710 History of Changes |
| Other Study ID Numbers: | H07-01816 |
| Study First Received: | January 3, 2008 |
| Last Updated: | July 11, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Randomized double-blind superiority trial |
Additional relevant MeSH terms:
|
Marfan Syndrome Arachnodactyly Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn Connective Tissue Diseases Limb Deformities, Congenital Musculoskeletal Abnormalities |
Atenolol Losartan Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013