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Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054938
Recruitment Status : Completed
First Posted : February 14, 2003
Last Update Posted : December 24, 2013
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Matthew H. Liang, MD, Brigham and Women's Hospital

Brief Summary:
The purpose of this study is to find the best way to prevent heart disease and stroke in people with lupus (systemic lupus erythematosis, or SLE). The study will evaluate the effectiveness of medication and a phone-based education program in controlling four risk factors for heart disease: smoking, obesity, high blood pressure, and inactivity. The study will also test the safety of commonly used heart medications in people with lupus.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Lupus Drug: pravastatin Drug: aspirin Drug: ramipril Drug: Vitamins: B6, B12, and folate Behavioral: heart health educational program Phase 2

Detailed Description:

People with SLE are at much higher risk for mortality due to atherosclerotic vascular disease (ASVD). Available data suggest that the usual mechanics of and risk factors for atherosclerosis are enhanced by factors such as corticosteroid use and SLE itself. This study will evaluate a medication and education program designed to prevent ASVD complications (primary prevention) or their recurrence (secondary prevention). The study will also measure the compliance and retention rate for the prevention program over 4 years.

Participants in this study will be randomized to receive either preventive heart disease medications or placebo. Participants in the medication arm will receive pravastatin alone or in combination with the following: aspirin, ramipril, or a combination of vitamins B6, B12, and folate. All participants in this study will receive basic education on how to optimize their heart health. Educational material will be sent to the patients as well as to support persons whom they have named. One group will receive tailored education based on a particular risk factor. Participants will have three study visits and follow-up telephone visits four times a year. Study visits will include a medical history and basic laboratory blood tests. Participants with documented high blood pressure will receive a home monitoring unit and be asked to monitor their blood pressure. Participants will be followed for 2 to 4 years.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot Study
Study Start Date : March 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • SLE as defined by the 1997 American College of Rheumatology criteria
  • Acceptable methods of contraception

Exclusion Criteria

  • Participation in another experimental protocol for ASVD prevention
  • Heavy alcohol consumption ( >= 3 drinks/day)
  • Aspirin intolerance
  • Certain medications, including coumadin, ACE inhibitors, potassium supplements, potassium sparing diuretics, cyclosporine, and lithium
  • Peptic ulcer disease within 6 months prior to study entry
  • History of an intracranial bleed or brain tumor
  • Bleeding diathesis
  • History of allergy or sensitivity to ACE inhibitors
  • Uncontrolled high blood pressure (180 mm Hg/110 mm Hg)
  • Creatinine > 2.0 mg/dl
  • Renal artery stenosis
  • Pregnant or breastfeeding
  • Abnormal liver function tests (ALT > 2 X upper limit of normal)
  • History of a muscle disease, or baseline CPK > 500U/L or 2 X upper limit of normal

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 identifier (NCT number): NCT00054938

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United States, Massachusetts
Brigham and Women's Hospital, RBB Brigham Arthritis Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Principal Investigator: Matthew H. Liang, MD, MPH Brigham and Women's Hospital

Publications of Results:
Other Publications:
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Responsible Party: Matthew H. Liang, MD, Professor of Medicine, Brigham and Women's Hospital Identifier: NCT00054938     History of Changes
Other Study ID Numbers: P60 AR47782 NIAMS-077
P60AR047782 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2003    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013
Keywords provided by Matthew H. Liang, MD, Brigham and Women's Hospital:
Accelerated Atherosclerosis
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors