Early and Personalized Cardiovascular Disease Preventive Care in Lupus Nephritis (EPiC-LN)

PROJECT SUMMARY/ABSTRACT Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in patients with lupus nephritis (LN). Moreover, LN patients of Black race face even higher ASCVD risk. Less than 15% of eligible LN patients receive ASCVD prevention. This is because clinicians and patients need to know: a) who is at risk and will benefit

most from ASCVD prevention; b) how to start and tailor therapies per each patient’s risk; and c) what is the efficacy and safety of ASCVD therapies during pregnancy—fears of young women that lead to stopping such therapies. This proposal is designed to provide Dr. Shivani Garg, MD, MS with the training needed to become

an independent physician scientist researching interventions to improve ASCVD prevention in LN. The goal of the proposed research is to develop effective ASCVD preventive interventions that support clinicians and patients in decision-making and support use of ASCVD-risk reducing therapies to improve outcomes and

survival in LN. Garg’s earlier innovative work identified that subclinical renal arteriosclerosis in kidneys at LN diagnosis is a window into the heart. This approach can identify patients who will benefit from ASCVD prevention at LN diagnosis. To answer the two remaining questions/concerns of patients and clinicians, Garg’s project will:

a) Develop an implementation guide for clinicians to support decisions to 1) tailor ASCVD prevention by each patient’s risk; and 2) start ASCVD-risk reducing therapies based on evidence for effectiveness and safety (Aim 1). Using a validated method that combines scientific evidence from literature and expert consensus this

guide will be developed. A retrospective performance testing will be done to test its public health impact. b) Create a shared decision-making tool to support patients and clinicians in decision-making and identifying the best aligned approach to their personalized ASCVD preventive care (Aim 2). This tool will be informed by

feedback from multidisciplinary experts, clinicians, and patients of diverse backgrounds to ensure biases and difficult concepts are addressed thereby delivering a racially, culturally, and socially appropriate tool. c) Test the guide and shared decision-making tool in clinics to evaluate if patients and clinicians will adopt, use,

and recommend the tools (Aim 3). Additionally, this step will inform the real-world impact and feasibility of using such interventions in busy clinics. The data from this project, along with the novel correlations with subclinical renal arteriosclerosis, offer a foundation for a multi-site R01 study to test the effectiveness of ASCVD preventive interventions in reducing the

risk of ASCVD in LN. Dr. Garg is in an ideal environment to complete this research and receive mentored training in implementation and decision science, qualitative methods, health equity, and clinical trials. This proposal addresses a significant clinical dilemma and serious gaps in ASCVD prevention research in LN and offers critical

support for her growth to lead ASCVD prevention research to improve outcomes and equity in LN.