In a recent editorial, DCRI faculty call for improved heart failure trial enrollment, as well as modifications to the infrastructure used to evaluate whether treatments work in real-world settings.
A recent editorial in JACC: Heart Failure written by the DCRI’s Adam DeVore, MD, and Adrian Hernandez, MD, MHS, calls for improvements in enrollment for heart failure trials, as well as advanced methods for assessing effectiveness of heart failure therapies in real-world settings.
Findings from recent clinical trials have added to the number of therapies available for treating heart failure. However, because clinical trial populations are not always representative of clinical care populations, it is necessary to conduct additional studies to ensure the effectiveness of therapies in real-world settings. DeVore (pictured left) and Hernandez’s (pictured right) editorial accompanied results from one such observational study, which used claims data and was conducted by the Mayo Clinic’s Nicholas Tan, MD, MS, and colleagues.
DeVore and Hernandez commend the study, which found improved outcomes for patients treated with sacubitril-valsartan over those treated with ACEIs/ARBs. However, these improved outcomes did not extend to black patients, opening an opportunity for further investigation. “Resolving effectiveness in black Americans should be a top research priority,” DeVore and Hernandez write.
In the editorial, they suggest this anomaly could be a result of limited sample sizes, residual confounding, or selection bias, and they call for better ways to address these challenges, as well as improvements to the infrastructure for evaluating therapies in real-world settings. Current observational studies rely primarily on claims data, like Tan’s study, which lacks important information needed for phenotyping, or on registries, which can be expensive and challenging to maintain. Moving forward, DeVore and Hernandez write, the heart failure community must identify ways to leverage the electronic health record, which would provide in-depth information about heart failure treatment in a real-world setting.
The editorial also recommends an effort to improve enrollment so that future heart failure trials will be more representative of real-world populations. Although this solution is complex, engagement with patients, clinicians, health systems, and other stakeholders will be paramount.