A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 150
- Locations
- 1
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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Intervention: Vitamins: B6, B12, and folate (Drug)
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Intervention: heart health educational program (Behavioral)
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Intervention: aspirin (Drug)
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Intervention: pravastatin (Drug)
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Intervention: ramipril (Drug)
Investigators
Matthew H. Liang, MD
Professor of Medicine
Brigham and Women's Hospital