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Solomon, SD; Ostrominski, JW; Vaduganathan, M; Claggett, B; Jhund, PS; Desai, AS; Lam, CSP; Pitt, B; Senni, M; Shah, SJ; Voors, AA; Zannad, F; Abidin, IZ; Alcocer-Gamba, MA; Atherton, JJ; Bauersachs, J; Ma, CS; Chiang, CE; Chioncel, O; Chopra, V; Comin-Colet, J; Filippatos, G; Fonseca, C; Gajos, G; Goland, S; Goncalvesová, E; Kang, SM; Katova, T; Kosiborod, MN; Latkovskis, G; Lee, AP; Linssen, GCM; Llamas-Esperón, G; Mareev, V; Martinez, FA; Melenovský, V; Merkely, B; Nodari, S; Petrie, MC; Saldarriaga, CI; Saraiva, JFK; Sato, N; Schou, M; Sharma, K; Troughton, R; Udell, JA; Ukkonen, H; Vardeny, O; Verma, S; von, Lewinski, D; Voronkov, LG; Yilmaz, MB; Zieroth, S; Lay-Flurrie, J; van, Gameren, I; Amarante, F; Viswanathan, P; McMurray, JJV.
Baseline characteristics of patients with heart failure with mildly reduced or preserved ejection fraction: The FINEARTS-HF trial.
Eur J Heart Fail. 2024; 26(6): 1334-1346.
Doi: 10.1002/ejhf.3266
Web of Science
PubMed
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- Co-Autor*innen der Med Uni Graz
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von Lewinski Dirk
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- Abstract:
- 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.
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Humans - administration & dosage
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Heart Failure - physiopathology, drug therapy
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Stroke Volume - physiology
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Female - administration & dosage
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Male - administration & dosage
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Aged - administration & dosage
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Mineralocorticoid Receptor Antagonists - therapeutic use
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Naphthyridines - therapeutic use
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Double-Blind Method - administration & dosage
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Ventricular Function, Left - physiology, drug effects
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Middle Aged - administration & dosage
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Treatment Outcome - administration & dosage
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Glomerular Filtration Rate - physiology
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Natriuretic Peptide, Brain - blood
- Find related publications in this database (Keywords)
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Clinical trials
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Heart failure with mildly reduced or preserved ejection fraction
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Mineralocorticoid receptor antagonists