Autor(es):
Solomon, Scott D. ; Ostrominski, John W. ; Vaduganathan, Muthiah ; Claggett, Brian ; Jhund, Pardeep S. ; Desai, Akshay S. ; Lam, Carolyn S.P. ; Pitt, Bertram ; Senni, Michele ; Shah, Sanjiv J. ; Voors, Adriaan A. ; Zannad, Faiez ; Abidin, Imran Zainal ; Alcocer-Gamba, Marco Antonio ; Atherton, John J. ; Bauersachs, Johann ; Ma, Chang Sheng ; Chiang, Chern En ; Chioncel, Ovidiu ; Chopra, Vijay ; Comin-Colet, Josep ; Filippatos, Gerasimos ; Fonseca, Cândida ; Gajos, Grzegorz ; Goland, Sorel ; Goncalvesová, Eva ; Kang, Seok Min ; Katova, Tzvetana ; Kosiborod, Mikhail N. ; Latkovskis, Gustavs ; Lee, Alex Pui Wai ; Linssen, Gerard C.M. ; Llamas-Esperón, Guillermo ; Mareev, Vyacheslav ; Martinez, Felipe A. ; Melenovský, Vojtěch ; Merkely, Béla ; Nodari, Savina ; Petrie, Mark C. ; Saldarriaga, Clara Inés ; Saraiva, Jose Francisco Kerr ; Sato, Naoki ; Schou, Morten ; Sharma, Kavita ; Troughton, Richard ; Udell, Jacob A. ; Ukkonen, Heikki ; Vardeny, Orly ; Verma, Subodh ; von Lewinski, Dirk ; Voronkov, Leonid G. ; Yilmaz, Mehmet Birhan ; Zieroth, Shelley ; Lay-Flurrie, James ; van Gameren, Ilse ; Amarante, Flaviana ; Viswanathan, Prabhakar ; McMurray, John J.V.
Data: 2024
Identificador Persistente: http://hdl.handle.net/10362/168691
Origem: Repositório Institucional da UNL
Assunto(s): Clinical trials; Heart failure with mildly reduced or preserved ejection fraction; Mineralocorticoid receptor antagonists; Cardiology and Cardiovascular Medicine
Descrição
Publisher Copyright: © 2024 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
Aims: To describe the baseline characteristics of participants in the FINEARTS-HF trial, contextualized with prior trials including patients with heart failure (HF) with mildly reduced and preserved ejection fraction (HFmrEF/HFpEF). The FINEARTS-HF trial is comparing the effects of the non-steroidal mineralocorticoid receptor antagonist finerenone with placebo in reducing cardiovascular death and total worsening HF events in patients with HFmrEF/HFpEF. Methods and results: Patients with symptomatic HF, left ventricular ejection fraction (LVEF) ≥40%, estimated glomerular filtration rate ≥ 25 ml/min/1.73 m2, elevated natriuretic peptide levels and evidence of structural heart disease were enrolled and randomized to finerenone titrated to a maximum of 40 mg once daily or matching placebo. We validly randomized 6001 patients to finerenone or placebo (mean age 72 ± 10 years, 46% women). The majority were New York Heart Association functional class II (69%). The baseline mean LVEF was 53 ± 8% (range 34–84%); 36% of participants had a LVEF <50% and 64% had a LVEF ≥50%. The median N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 1041 (interquartile range 449–1946) pg/ml. A total of 1219 (20%) patients were enrolled during or within 7 days of a worsening HF event, and 3247 (54%) patients were enrolled within 3 months of a worsening HF event. Compared with prior large-scale HFmrEF/HFpEF trials, FINEARTS-HF participants were more likely to have recent (within 6 months) HF hospitalization and greater symptoms and functional limitations. Further, concomitant medications included a larger percentage of sodium–glucose cotransporter 2 inhibitors and angiotensin receptor–neprilysin inhibitors than previous trials. Conclusions: FINEARTS-HF has enrolled a broad range of high-risk patients with HFmrEF and HFpEF. The trial will determine the safety and efficacy of finerenone in this population.
