EASi-HF Reduced

Summary

Currently, 1 in 5 people is at risk of developing heart failure (HF) at some point in their lifetime. Effectively managing the symptoms of chronic HF—including shortness of breath, fatigue, and fluid retention—can decrease the burden of this disease and enhance patients’ quality of life. The medication empagliflozin helps the body get rid of excess fluid. This lowers blood pressure, decreases how hard the heart has to work, and reduces the risk of heart-associated complications and hospitalizations. Vicadrostat is an investigational compound that—like empagliflozin—works to lower blood pressure and fluid retention, but in a different way. In EASi-HF Reduced, researchers hope that combining vicadrostat with empagliflozin will further reduce the symptoms and risks of chronic HF and improve patient outcomes.

Once participants are cleared to join EASi-HF Reduced, they're assigned randomly (50:50, like a coin toss) to receive a once-a-day tablet containing both vicadrostat and empagliflozin or a once-a-day tablet that contains only empagliflozin. Neither the lead scientist nor the participant can choose or will know which treatment they receive. During the study, participants will continue all their other medications as directed. Participants can anticipate being involved in EASi-HF Reduced for 6 months to 3.5 years, depending on their response to the assigned treatment.

To be included in EASi-HF Reduced, participants must be / have

• Adult (18 years of age and older)
• Diagnosed with chronic HF and poor pumping activity (LVEF less than 40%) at least 3 months before the first study visit
• Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) level at the first study visit

To be included in EASi-HF Reduced, participants must not be / have

• Treatment with a mineralocorticoid receptor agonist (for example, spironolactone, eplerenone, finerenone) or with a potassium-sparing diuretic (for example, amiloride) within 14 days before the first study visit
• History of or plan for myocardial infarction (heart attack), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery, or heart valve surgery/intervention within 90 days before the second study visit
• History of or plan for any other major surgery or major elective surgery (for example, hip replacement, coronary artery bypass surgery) within 90 days of the second study visit

Keywords
Chronic heart failure; Heart failure