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Cardiology Prevention in Systemic Lupus Erythematosus (SLE)

This study is not yet open for participant recruitment.
Verified by University of Pittsburgh, October 2008

Sponsors and Collaborators: University of Pittsburgh
Arthritis Foundation
National Institutes of Health (NIH)
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00610805
  Purpose

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.


Condition Intervention
Systemic Lupus Erythematosus
Other: Preventive Cardiology
Other: Usual Care

MedlinePlus related topics:   Lupus   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind (Investigator), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:   Cardiology Prevention Trial in Systemic Lupus Erythematosus

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The efficacy of a preventive cardiology program compared to usual care in slowing the progression of carotid IMT and plaque [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The effect of a preventive cardiology program versus usual care at achieving CV risk factor target goals. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:   30
Study Start Date:   November 2009
Estimated Study Completion Date:   November 2011
Estimated Primary Completion Date:   November 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Participants randomized to this arm (n=15) will be followed by Preventive Cardiology and will have appropriate goal oriented interventions on their risk factor levels for 2 years.
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.
2
Participants randomized to this arm (n=15) will receive usual care. The PI will send a letter of all testing results to their primary care physician. No standard care will be withheld.
Other: Usual Care
Participants will receive usual care per their primary care physician.

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
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610805

Contacts
Contact: Jennifer R Elliott, MD     412-648-8708     elliottjr@upmc.edu    
Contact: Linda Santelices, MS     412-641-7637     slinda@pitt.edu    

Locations
United States, Pennsylvania
Lupus Center of Excellence, Magee Womens Hospital, 300 Halket St, Suite 1750     Not yet recruiting
      Pittsburgh, Pennsylvania, United States, 15213
      Contact: Jennifer R Elliott, MD     412-648-8708     elliottjr@upmc.edu    
      Contact: Linda Santelices, MS     412-641-7637     slinda@pitt.edu    
      Principal Investigator: Jennifer R Elliott, MD            
Clinical and Translational Research Center (CTRC), Montefiore Hospital, 6NE, 200 Lothrop St.     Not yet recruiting
      Pittsburgh, Pennsylvania, United States, 15261

Sponsors and Collaborators
University of Pittsburgh
Arthritis Foundation
National Institutes of Health (NIH)

Investigators
Principal Investigator:     Jennifer R Elliott, MD     University of Pittsburgh    
  More Information


Responsible Party:   University of Pittsburgh ( Jennifer Elliott, MD )
Study ID Numbers:   PRO07050181
First Received:   January 24, 2008
Last Updated:   October 3, 2008
ClinicalTrials.gov Identifier:   NCT00610805
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
SLE  
lupus  
cardiovascular  
IMT  
Systemic Lupus Erythematosus  

Study placed in the following topic categories:
Autoimmune Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on October 15, 2008




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