Clinical trial NCT00610805: Cardiology Prevention in Systemic Lupus Erythematosus (SLE)
Official title: Cardiology Prevention Trial in Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
lupus
cardiovascular
IMT
Systemic Lupus Erythematosus
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Arthritis Foundation
name: National Institutes of Health (NIH)
First posted: 2008-02-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We propose a feasibility study of aggressive CV risk factor management directed by preventive cardiology compared to usual care. We will determine: 1) the efficacy of a preventive cardiology program compared to usual care in slowing the progression of carotid IMT and plaque, and 2) the effect of a preventive cardiology program versus usual care at achieving CV risk factor target goals.

We hypothesize Lupus patients randomized to the preventive cardiology program will have less cardiovascular progression over two years than those lupus patients who are given standard care for cardiovascular risk, defined by carotid intima-media thickness and plaque.

Detailed description: We will recruit 30 eligible patients from the Lupus Center of Excellence outpatient clinic. Patients will either be randomized into a preventive cardiology program for aggressive treatment, or randomized to usual care (1:1 ratio) in a single-blinded, randomized trial of 24 months duration. In this feasibility trial we hope to identify and refine any limitations in anticipation of designing a larger, randomized intervention study.

For both arms of the study, at baseline, 6 month, 12 month, 18 month, and 24 month visits (5 visits in total) all patients will be seen by Dr. Elliott, Principal Investigator. Visits will include an interview, fasting laboratory tests completion of questionnaires regarding demographics, socioeconomic status, health status, and risk factors (traditional, inflammatory, and lupus-specific). Dr. Elliott will perform the physical examinations on all patients and complete the lupus-specific disease activity and damage questionnaires. At the Baseline visit, 12-month visit, and 24 24-month visits, all patients will have a carotid ultrasound.

Cohort 1: Preventive Cardiology Program arm: Above and beyond the standard care, which is listed below, the patients in this arm will be aggressively treated by the cardiologist. As deemed prudent, the following may be prescribed: antihypertensives, lipid reducing agents, anti-platelets, further cardiac testing, and behavioral modifications. No standard care treatment will be withheld.

Cohort 2: Standard Care arm: The PI will send a letter of all testing results to their designated PCP. No standard care treatment will be withheld.

Eligibility criteria: Inclusion Criteria:

1. Definitive diagnosis of SLE
2. \>18 years of age
3. Followed by rheumatologists (not the investigator, Dr. Elliott) at the Lupus Center of Excellence
4. Informed consent signed
5. Effective form of birth control

Exclusion Criteria:

1. Prior cardiovascular disease history (MI, coronary angioplasty, coronary artery bypass graft, abnormal coronary angiography, abnormal nuclear or treadmill stress test)
2. Prior evaluation by preventive cardiology
3. Active cardiac issues
4. Pregnancy, breastfeeding, or anticipating pregnancy in the next 2 years

Primary outcomes:
measure: The efficacy of a preventive cardiology program compared to usual care in slowing the progression of carotid IMT and plaque
timeFrame: 2 years
measure: The effect of a preventive cardiology program versus usual care at achieving CV risk factor target goals.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Lupus Center of Excellence, Magee Womens Hospital, 300 Halket St, Suite 1750
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical and Translational Research Center (CTRC), Montefiore Hospital, 6NE, 200 Lothrop St.
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jennifer R Elliott, MD
role: PRINCIPAL_INVESTIGATOR
References: