Despite the robust literature demonstrating improved outcomes with the use of mineralocorticoid antagonists (MRAs) in patients with heart failure with reduced ejection fraction, they continue to be underused in clinical practice. This underuse often stems from the perceived risks of hyperkalemia, including a prior history of hyperkalemia and acute or chronic kidney disease, as well as the cautioned use for those with elevated potassium, as recommended in national societal guidelines. In fact, our pilot data across the Yale New Haven Health System confirms this, showing similar use of evidence-based heart failure therapies as noted in the most current and comprehensive registry—CHAMP-HF.

In addition, new potassium binders have recently been approved by the United States Food and Drug Administration (FDA) to treat hyperkalemia that are more advantageous that other currently available alternatives.

This is the problem that PROMPT-MRA seeks to address. Although it remains unclear as to why many patients with HFrEF are not on a mineralocorticoid antagonist, it could be due to a lack of comfort prescribing these medications in the setting on chronic kidney disease and potential hyperkalemia as well as knowledge of available therapies to treat hyperkalemia.  A simple way to test these hypotheses is to examine whether electronic health record (EHR) based "best practice advisories" (BPAs) can increase use of evidence-based therapies.

Through a randomized controlled trial across outpatient clinics across the Yale New Haven Health System, the study will compare the effectiveness of an EHR BPA system that informs physicians of mineralocorticoid antagonists to prescribe for eligible patients with HFrEF with a usual care group which receives no alert. The alerts will also inform physicians about available potassium binders to treatment for hyperkalemia. Between these groups, the primary outcome observed will be the proportion of patients with HFrEF with an increase in prescribed mineralocorticoid antagonists. Other outcomes observed will include the incidence of hyperkalemia, proportion of patients prescribed potassium binders, the percent of filled prescriptions as assessed by Sure Scripts, medication doses, 1-, 3-, 6-, and 12-month hospital heart failure admission rates, all-cause ED visits, and all-cause mortality, and 1-, 3-, 6-, and 12-month total healthcare cost.

This study is sponsored by a grant from Vifor Pharma.