Losartan Versus Atenolol for the Treatment of Marfan Syndrome

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00593710
First received: January 3, 2008
Last updated: July 11, 2012
Last verified: July 2012
  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

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 ]

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
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
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 August 21, 2014