Baseline characteristics of patients with heart failure with mildly reduced or preserved
ejection fraction: The FINEARTS-HF trial
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, Candida; Gajos, Grzegorz; Goland, Sorel; Goncalvesova, Eva; Kang, Seok-Min; Katova, Tzvetana; Kosiborod, Mikhail N.; Latkovskis, Gustavs; Lee, Alex Pui-Wai; Linssen, Gerard C. M.; Llamas-Esperon, Guillermo; Mareev, Vyacheslav; Martinez, Felipe A.; Melenovsky, Vojtech; Merkely, Bela [Merkely, Béla Péter (Kardiológia), author] Cardiovascular Center (SU
/ FM / C); Department of Cardiology – Heart and Vascular C... (SU / FM / C); Faculty
of Sports Medicine (SU / FM / C); Aerospace Medicine Department (SU / FM / C); Nodari, Savina; Petrie, Mark C.; Saldarriaga, Clara Ines; 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.
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
m(2), 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. [GRAPHICS]
