Cardiology Prevention in Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus Clinical Trial

Official title:

Cardiology Prevention Trial in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00610805
• Other study ID #: PRO07050181
• Status: Withdrawn
• Phase: N/A
• First received: January 24, 2008
• Last updated: January 14, 2016
• Start date: November 2009
• Est. completion date: November 2009

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Other:
• Preventive Cardiology
Patients will receive those interventions recommended by the Preventive Cardiologist. This may include: exercise, electrocardiogram, specialized blood testing, blood pressure monitoring, nutrition counseling, smoking cessation counseling, and pharmacotherapy for hypercholesterolemia, hypertension, and blood sugar abnormalities.
• Usual Care
Participants will receive usual care per their primary care physician.

Locations

Country	Name	City	State
United States	Clinical and Translational Research Center (CTRC), Montefiore Hospital, 6NE, 200 Lothrop St.	Pittsburgh	Pennsylvania
United States	Lupus Center of Excellence, Magee Womens Hospital, 300 Halket St, Suite 1750	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Arthritis Foundation, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of a preventive cardiology program compared to usual care in slowing the progression of carotid IMT and plaque		2 years	No
Primary	The effect of a preventive cardiology program versus usual care at achieving CV risk factor target goals.		2 years	No