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Losartan Versus Atenolol for the Treatment of Marfan Syndrome
This study is currently recruiting participants.
Verified by University of British Columbia, July 2008
First Received: January 3, 2008   Last Updated: July 8, 2008   History of Changes
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Pulse Wave Velocity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593710

Contacts
Contact: Leslie Raffin, RN 778-388-3162 lraffin@cw.bc.ca

Locations
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    
Sponsors and Collaborators
University of British Columbia
Heart and Stroke Foundation of Canada
Investigators
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 ( 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

Keywords provided by University of British Columbia:
Randomized
double-blind superiority trial

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010