Title: Use of Real-World Evidence to Characterize Patients with Uncontrolled Hypertension

Technology of Interest: Electrode Renal Denervation System

Disease Area: Cardiovascular

Duration: 12 months

Network Collaborator(s): Yale New Haven Hospital; One Florida Health System

This Test-Case will assess the feasibility of NESTcc Data Network collaborators using electronic health records (EHRs) to gather relevant real-world data (RWD) to better characterize numbers of and outcomes experienced by patients with uncontrolled hypertension.  This Test-Case is focused on understanding the population of patients potentially eligible for multi-electrode renal denervation system (RDN), which is a minimally invasive, catheter-based therapy that delivers energy to the nerves leading to the kidneys that helps regulate blood pressure.

Hypertension (HTN) is the single largest modifiable contributor to death and poses a significant clinical and economic burden to patients and communities.  Patients with HTN are at an increased risk for heart attack, stroke, heart failure, and kidney failure.  It is estimated that in the United States, 1 in 2 adults have HTN.  Despite availability of effective antihypertensive medications, less than half of patients with HTN achieve blood pressure control.  This study will use RWD from health systems to retrospectively identify adult patients with uncontrolled HTN, understand their demographic and clinical characteristics, medication treatment patterns, and both short-term and long-term clinical outcomes.  This project seeks to leverage RWD to better characterize the population that may benefit most from identification and better management of poorly-controlled hypertension.

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Today at 4:30 p.m. CT, NESTcc Chief of Staff @RachelRRath will present at the 5th Annual Evening of Pediatric Device Innovation, joining experts from Houston and across the country to discuss real world evidence (RWE). More: bit.ly/2DRlny0 pic.twitter.com/v5rhJ1qZBU 2 days ago

At the FDA/CMS Summit today at 4:30 p.m., join Data Network Director @robbert_z for a panel discussion on expanding the role of real-world evidence and patient-reported outcomes in regulatory decision-making. #RWE More: bit.ly/360vmgv pic.twitter.com/DcGyCnCCOD 4 days ago

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