Cardiology Prevention in Systemic Lupus Erythematosus (SLE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Pittsburgh.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Arthritis Foundation
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00610805
First received: January 24, 2008
Last updated: October 3, 2008
Last verified: October 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Clinical and Translational Research Center (CTRC), Montefiore Hospital, 6NE, 200 Lothrop St. Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15261
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         
Sponsors and Collaborators
University of Pittsburgh
Arthritis Foundation
Investigators
Principal Investigator: Jennifer R Elliott, MD University of Pittsburgh
  More Information

No publications provided

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

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

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

ClinicalTrials.gov processed this record on October 23, 2014