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Cardiology Prevention in Systemic Lupus Erythematosus (SLE)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610805
First Posted: February 8, 2008
Last Update Posted: January 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Arthritis Foundation
National Institutes of Health (NIH)
Information provided by:
University of Pittsburgh
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Cardiology Prevention Trial in Systemic Lupus Erythematosus

Resource links provided by NLM:


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 ]
  • The effect of a preventive cardiology program versus usual care at achieving CV risk factor target goals. [ Time Frame: 2 years ]

Enrollment: 0
Study Start Date: November 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610805


Locations
United States, Pennsylvania
Lupus Center of Excellence, Magee Womens Hospital, 300 Halket St, Suite 1750
Pittsburgh, Pennsylvania, United States, 15213
Clinical and Translational Research Center (CTRC), Montefiore Hospital, 6NE, 200 Lothrop St.
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: Jennifer Elliott, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00610805     History of Changes
Other Study ID Numbers: PRO07050181
First Submitted: January 24, 2008
First Posted: February 8, 2008
Last Update Posted: January 15, 2016
Last Verified: January 2016

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

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases