Baseline characteristics of patients with heart failure with mildly reduced or preserved ejection fraction: The FINEARTS-HF trial

Solomon SD 1 , Ostrominski JW 1 , Vaduganathan M 1 , Claggett B 1 , Jhund PS 2 , Desai AS 1 Show all authors , Lam CSP 3 , Pitt B 4 , Senni M 5 , Shah SJ 6 , Voors AA 7 , Zannad F 8 , Abidin IZ 9 , Alcocer-Gamba MA 10 , Atherton JJ 11 , Bauersachs J 12 , Ma CS 13 , Chiang CE 14 , Chioncel O 15 , Chopra V 16 , Comin-Colet J 17 , Filippatos G 18 , Fonseca C 19 , Gajos G 20 , Goland S 21 , Goncalvesová E 22 , Kang SM 23 , Katova T 24 , Kosiborod MN 25 , Latkovskis G 26 , Lee AP 27 , Linssen GCM 28 , Llamas-Esperón G 29 , Mareev V 30 , Martinez FA 31 , Melenovský V 32 , Merkely B 33 , Nodari S 34 , Petrie MC 2 , Saldarriaga CI 35 , Saraiva JFK 36 , Sato N 37 , Schou M 38 , Sharma K 39 , Troughton R 40 , Udell JA 41 , Ukkonen H 42 , Vardeny O 43 , Verma S 44 , von Lewinski D 45 , Voronkov LG 46 , Yilmaz MB 47 , Zieroth S 48 , Lay-Flurrie J 49 , van Gameren I 50 , Amarante F 51 , Viswanathan P 52 , McMurray JJV 2

Affiliations 

  • 1 Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
  • 2 BHF Glasgow Cardiovascular Research Center, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK
  • 3 National Heart Centre Singapore & Duke-National University of Singapore, Singapore, Singapore
  • 4 University of Michigan, School of Medicine, Ann Arbor, MI, USA
  • 5 University Bicocca Milan, Italy, and, Papa Giovanni XXIII Hospital, Bergamo, Italy
  • 6 Northwestern University Feinberg School of Medicine, Chicago, IL, USA
  • 7 University Medical Center Groningen, Groningen, The Netherlands
  • 8 Université de Lorraine, Inserm Clinical Investigation Centre, CHU, Nancy, France
  • 9 University of Malaya, Kuala Lumpur, Malaysia
  • 10 Centro de Estudios Clínicos de Querétaro, Querétaro, Mexico
  • 11 Cardiology Research Department, Royal Brisbane and Women's Hospital, University of Queensland, Brisbane, QLD, Australia
  • 12 Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany
  • 13 Beijing Anzhen Hospital, Capital Medical University, Beijing, China
  • 14 Taipei Veterans General Hospital, Taipei, Taiwan
  • 15 Emergency Institute for Cardiovascular Diseases 'Prof. Dr. C.C. Iliescu', University of Medicine Carol Davila, Bucharest, Romania
  • 16 Clinical Cardiology, Heart Failure and Research, Max Super Specialty Hospital, New Delhi, India
  • 17 Department of Cardiology, Bellvitge University Hospital and Bellvitge Biomedical Research Institute, CIBER-CV, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain
  • 18 Department of Cardiology, Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece
  • 19 Department of Internal Medicine, Hospital São Francisco Xavier, NOVA Medical School, Universidade Nova de Lisboa, Lisbon, Portugal
  • 20 Department of Coronary Disease and Heart Failure, Jagiellonian University Medical College, Kraków, Poland
  • 21 Heart Failure Unit, Kaplan Medical Center, Rehovot, Israel
  • 22 Faculty of Medicine, Comenius University, Bratislava, Slovakia
  • 23 Division of Cardiology, Severance Hospital, Yonsei University Health System, Seoul, South Korea
  • 24 Department of Noninvasive Cardiology, National Cardiology Hospital, Sofia, Bulgaria
  • 25 Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA
  • 26 Latvian Center of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia
  • 27 Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Hong Kong, China
  • 28 Department of Cardiology, Hospital Group Twente, Almelo, The Netherlands
  • 29 Hospital Cardiologico Aguascalientes, Aguascalientes, Mexico
  • 30 University Clinic of Lomonosov Moscow State University, Moscow, Russia
  • 31 Universidad Nacional de Córdoba, Córdoba, Argentina
  • 32 Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
  • 33 Heart and Vascular Center, Semmelweis University, Budapest, Hungary
  • 34 Department of Cardiology, University of Brescia and ASST 'Spedali Civili' Hospital, Brescia, Italy
  • 35 Centro Cardiovascular Colombiano, Clínica Santa María, Antioquia, Colombia
  • 36 Cardiovascular Division, Instituto de Pesquisa Clínica de Campinas, Campinas, Brazil
  • 37 Kawaguchi Cardiovascular and Respiratory Hospital, Saitama, Japan
  • 38 Department of Cardiology, Herlev-Gentofte University Hospital, Hellerup, Denmark
  • 39 Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
  • 40 Christchurch Heart Institute, Department of Medicine, University of Otago, Christchurch, New Zealand
  • 41 Women's College Hospital and Peter Munk Cardiac Centre, Toronto General Hospital, University of Toronto, Toronto, ON, Canada
  • 42 Heart Centre, Turku University Hospital, Turku, Finland
  • 43 Department of Medicine, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, MN, USA
  • 44 Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada
  • 45 Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
  • 46 National Scientific Center, Strazhesko Institute of Cardiology, National Academy of Medical Sciences, Kyiv, Ukraine
  • 47 Dokuz Eylul University Medical Faculty, Cardiology Department, Izmir, Turkey
  • 48 Section of Cardiology, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada
  • 49 Bayer plc, Research & Development, Pharmaceuticals, Reading, UK
  • 50 Bayer, Research & Development, Pharmaceuticals, Hoofddorp, The Netherlands
  • 51 Bayer, Research & Development, Pharmaceuticals, São Paulo, Brazil
  • 52 Bayer, Research & Development, Pharmaceuticals, Whippany, NJ, USA
Eur J Heart Fail, 2024 Jun;26(6):1334-1346.
PMID: 38733212 DOI: 10.1002/ejhf.3266

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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