Brigham-Led Clinical Trial Finds Finerenone Reduces Worsening Heart Failure and Cardiovascular Death

In a randomized, placebo-controlled trial, the drug improved outcomes in patients with heart failure and mildly reduced or preserved ejection fraction.

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 healthcare 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, funded by Bayer, 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.“

Authorship: In addition to Solomon, BWH researchers include Muthiah Vaduganathan, Brian Claggett, and Akshay Desai. Additional authors include co-corresponding author John McMurray from the University of Glasgow as well as Pardeep Jhund, Alasdair Henders, Carolyn Lam, Bertram Pitt, Michele Senni, Sanjiv Shah, Adriaan Voors, Faiez Zannad, Imran Zainal Abidin, Marco Antonio Alcocer-Gamba, John Atherton, Johann Bauersachs, Ma Chang-Sheng, Chern-En Chiang, Ovidiu Chioncel, Vijay Chopra, Josep Comin-Colet, Gerasimos Filippatos, Cândida Fonseca, Grzegorz Gajos, Sorel Goland, Eva Goncalvesova, Seokmin Kang, Tzvetana Katova, Mikhail Kosiborod, Gustavs Latkovskis, Alex Pui-Wai Lee, Gerard Linssen, Guillermo Llamas-Esperón, Vyacheslav Mareev, Felipe A. Martinez, Vojtěch Melenovský, Béla Merkely, Savina Nodari, Mark Petrie, Clara Inés Saldarriaga, Jose Francisco Kerr Saraiva, Naoki Sato, Morten Schou, Kavita Sharma, Richard Troughton, Jacob Udell, Heikki Ukkonen, Orly Vardeny, Subodh Verma, Dirk von Lewinski, Leonid Voronkov, Mehmet Birhan Yilmaz, Shelley Zieroth, James Lay-Flurrie, Ilse van Gameren, Flaviana Amarante, Peter Kolkhof, and Prabhakar Viswanathan.

Disclosures: Scott Solomon reports institutional research grants to Brigham and Women’s Hospital from Alexion, Alnylam, Applied Therapeutics, AstraZeneca, Bellerophon, Bayer, BMS, Boston Scientific, Cytokinetics, Edgewise, Eidos/Bridgebio, Gossamer, GSK, Ionis, Lilly,NIH/NHLBI, Novartis, NovoNordisk, Respicardia, Sanofi Pasteur, Tenaya, Theracos, and US2.

Funding: Bayer funded the FINEARTS-HF clinical trial (NCT04435626).

Paper cited: Solomon, S et al. “Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction” New England Journal of Medicine. DOI: 10.1056/NEJMoa2407107