Clinical trial finds finerenone reduces worsening heart failure and cardiovascular death

Finerenone reduced the composite of total first and recurrent heart failure (HF) events (hospitalizations for HF or urgent HF visits) and cardiovascular death in patients with HF and mildly reduced or preserved ejection fraction, according to an international clinical trial led by investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham health care system.

Heart failure events and cardiovascular death were less common in the finerenone group than in the placebo group. Overall, the rate of serious adverse events was similar across the groups, but rates of hyperkalemia—elevated levels of potassium in the blood—were higher for the group taking finerenone.

Results were presented at the European Society of Cardiology Congress 2024 and published simultaneously in the New England Journal of Medicine.

"We saw benefit regardless of the ejection fraction and even in patients who were on other approved therapies," said trial principal investigator and corresponding author Scott Solomon, MD, the director of the Clinical Trials Outcomes Center at Mass General Brigham and the Edward D. Frohlich Distinguished Chair at Brigham and Women's Hospital.

"This drug represents a new drug class that may become a pillar of therapy for this disease."

HF is the progressive decline in the heart's ability to fill with and pump blood. It affects over 60 million people worldwide. Approximately half of all people living with HF have mildly reduced or preserved left ventricular ejection fraction, a condition with limited treatment options. These findings suggest that the non-steroidal mineralocorticoid receptor antagonist finerenone could represent a new therapeutic option for patients.

The FINEARTS-HF trial assigned 6,000 patients to receive either finerenone or placebo in addition to their existing therapies. The trial's limitations include few Black patients, although the percentage of Black patients was proportional to their regional population.

"Our group continues to study novel therapies for heart failure," Solomon said. "There's huge residual risk in these patients and so more room for new therapies."