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Losartan Versus Atenolol for the Treatment of Marfan Syndrome

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ClinicalTrials.gov Identifier: NCT00593710
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : July 12, 2012
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
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 or disease Intervention/treatment Phase
Marfan Syndrome Drug: Losartan Drug: Atenolol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marfan Syndrome

Arm Intervention/treatment
Experimental: 1
Drug: Losartan
Losartan (25mg OD)

Active Comparator: 2
Drug: Atenolol
Atenolol (25-50mg OD)

Primary Outcome Measures :
  1. Pulse Wave Velocity [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Biophysical properties of the aorta [ Time Frame: 12 months ]
  2. Brachial artery reactivity [ Time Frame: 12 months ]
  3. Aortic root dimension and area [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects must conform to the diagnostic criteria for MFS;
  2. Subjects must be between 12 and 25 years;
  3. Subjects must have technically suitable echocardiographic windows to obtain the images needed to calculate the biophysical properties listed as outcome measures;
  4. Subjects must provide informed consent and/or assent.

Exclusion Criteria:

  1. Patients with significant aortic or mitral valve regurgitation;
  2. 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;
  3. Female patients who are pregnant, planning to become pregnant, or breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593710

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Canada, British Columbia
Children's Heart Centre, British Columbia's Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Heart and Stroke Foundation of Canada
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00593710    
Other Study ID Numbers: H07-01816
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012
Keywords provided by University of British Columbia:
double-blind superiority trial
Additional relevant MeSH terms:
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Marfan Syndrome
Pathologic Processes
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
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists