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

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054938
• Other study ID #: P60 AR47782 NIAMS-077
• Secondary ID: P60AR047782
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2003
• Last updated: December 23, 2013
• Start date: March 2003
• Est. completion date: December 2005

Study information

• Verified date: December 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Lupus
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• pravastatin

• aspirin

• ramipril

• Vitamins: B6, B12, and folate

Behavioral:
• heart health educational program

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital, RBB Brigham Arthritis Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Costenbader KH, Karlson EW, Gall V, de Pablo P, Finckh A, Lynch M, Bermas B, Schur PH, Liang MH. Barriers to a trial of atherosclerosis prevention in systemic lupus erythematosus. Arthritis Rheum. 2005 Oct 15;53(5):718-23. — View Citation

Costenbader KH, Liang MH. SLE - Practical and theoretical barriers to the prevention of accelerated atherosclerosis in systemic lupus erythematosus. Arthritis Res Ther. 2003;5(4):178-9. Epub 2003 May 23. — View Citation

Liang MH, Mandl LA, Costenbader K, Fox E, Karlson E. Atherosclerotic vascular disease in systemic lupus erythematosus. J Natl Med Assoc. 2002 Sep;94(9):813-9. — View Citation