Trial-Referenced Integrated Assessments of Data Sources for Real-World Evidence (TRIADS-RWE)

Trial-Referenced Integrated Assessments of Data Sources for Real-World Evidence (TRIADS-RWE)

Heart failure is a long-term condition where the heart cannot pump enough blood to meet the body's needs. It affects millions of people worldwide and often leads to repeated hospital stays and a higher risk of death. Doctors use several types of medicines to treat heart failure.One common group of medicines is ACE inhibitors (Angiotensin-Converting Enzyme inhibitors). These drugs help relax and widen blood vessels by blocking a chemical that normally makes blood vessels tighten. This lowers blood pressure and makes it easier for the heart to pump blood. Another closely related group is ARBs (Angiotensin Receptor Blockers), which also relax blood vessels and reduce the heart's workload but act on a different part of the same system.A newer treatment, sacubitril/valsartan, combines two medicines in one pill. One part (valsartan) is an ARB that lowers blood pressure and reduces strain on the heart. The other part (sacubitril) is a neprilysin inhibitor that helps the body maintain helpful natural hormones (i.e., natriuretic peptides) that reduce fluid buildup and relax blood vessels. Together, these effects help the heart work more efficiently. In a large clinical trial called PARADIGM-HF, sacubitril/valsartan was shown to reduce the risk of death and hospital admission compared with older treatments.However, people who join clinical trials are often different from patients seen in everyday medical care. Trial participants may be younger, have fewer other health problems, or receive closer follow-up. As a result, it is not always clear whether trial findings apply equally well to all patients.Our project will compare the results of the PARADIGM-HF trial with the experience of patients treated in three real-world healthcare settings, each representing a different part of the U.S. healthcare system:•   The University of North Carolina (UNC) Health Care System, a large academic medical system with hospitals and clinics across central North Carolina, reflecting how heart failure is treated in a typical regional healthcare network.•   The Veterans Health Administration (VHA), the largest integrated healthcare system in the United States and provides medical care to military veterans nationwide. It serves millions of patients through a national network of 170 medical centers and 1193 outpatient sites, serving 9.1 million Veterans each year. Because most care occurs within one national system, the VHA also allows more complete tracking of long-term health outcomes over time.•   IBM MarketScan, a large health insurance claims database representing working-age adults and retirees with private health insurance, capturing care received across many hospitals and providers outside government-run systems.In each setting, we will study adults with heart failure who start treatment with either sacubitril/valsartan or an ACE inhibitor or ARB. We will examine the same outcomes measured in the PARADIGM-HF trial, including death, hospital admission for heart failure, new atrial fibrillation (an irregular heart rhythm), and changes in kidney function.We will use established statistical methods to compare trial results with what happens in routine medical care. By examining multiple healthcare systems with different patient populations, this study will help determine when trial findings apply broadly and when results may differ across real-world settings.The goal of this research is to help doctors, patients, and policymakers better understand how evidence from clinical trials and real-world data can be combined to improve treatment decisions for people living with heart failure.

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