Losartan Versus Atenolol for the Treatment of Marfan Syndrome

NCT00593710 | Completed Phase 2 DMC

• 1 other identifier: H07-01816
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Marfan Syndrome

Keywords

Randomized; double-blind superiority trial

Outcome Measures

Primary Outcomes (1)

• Pulse Wave Velocity

  12 months

Secondary Outcomes (3)

• Biophysical properties of the aorta

  12 months

• Brachial artery reactivity

  12 months

• Aortic root dimension and area

  12 months

Study Arms (2)

1

EXPERIMENTAL

Losartan

Drug: Losartan

2

ACTIVE COMPARATOR

Atenolol

Drug: Atenolol

Interventions

Losartan DRUG

Losartan (25mg OD)

1

Atenolol DRUG

Atenolol (25-50mg OD)

2

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

Children's Heart Centre, British Columbia's Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (1)

• Sandor GG, Alghamdi MH, Raffin LA, Potts MT, Williams LD, Potts JE, Kiess M, van Breemen C. A randomized, double blind pilot study to assess the effects of losartan vs. atenolol on the biophysical properties of the aorta in patients with Marfan and Loeys-Dietz syndromes. Int J Cardiol. 2015 Jan 20;179:470-5. doi: 10.1016/j.ijcard.2014.11.082. Epub 2014 Nov 8.

  PMID: 25465809 DERIVED

MeSH Terms

Conditions

Marfan Syndrome

Interventions

Losartan; Atenolol

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines

Study Officials

• George Sandor, MD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Cornelius van Breemen, MD

  University of British Columbia

  STUDY DIRECTOR

• James E. Potts, MD

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 15, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2011
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

CA (1)