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

Scott D Solomon¹, John W Ostrominski¹, Muthiah Vaduganathan¹, Brian Claggett¹, Pardeep S Jhund², Akshay S Desai¹, Carolyn S P Lam³, Bertram Pitt⁴, Michele Senni⁵, Sanjiv J Shah⁶, Adriaan A Voors⁷, Faiez Zannad⁸, Imran Zainal Abidin⁹, Marco Antonio Alcocer-Gamba¹⁰, John J Atherton¹¹, Johann Bauersachs¹², Chang-Sheng Ma¹³, Chern-En Chiang¹⁴, Ovidiu Chioncel¹⁵, Vijay Chopra¹⁶, Josep Comin-Colet¹⁷, Gerasimos Filippatos¹⁸, Cândida Fonseca¹⁹, Grzegorz Gajos²⁰, Sorel Goland²¹, Eva Goncalvesová²², Seok-Min Kang²³, Tzvetana Katova²⁴, Mikhail N Kosiborod²⁵, Gustavs Latkovskis²⁶, Alex Pui-Wai Lee²⁷, Gerard C M Linssen²⁸, Guillermo Llamas-Esperón²⁹, Vyacheslav Mareev³⁰, Felipe A Martinez³¹, Vojtěch Melenovský³², Béla Merkely³³, Savina Nodari³⁴, Mark C Petrie², Clara Inés Saldarriaga³⁵, Jose Francisco Kerr Saraiva³⁶, Naoki Sato³⁷, Morten Schou³⁸, Kavita Sharma³⁹, Richard Troughton⁴⁰, Jacob A Udell⁴¹, Heikki Ukkonen⁴², Orly Vardeny⁴³, Subodh Verma⁴⁴, Dirk von Lewinski⁴⁵, Leonid G Voronkov⁴⁶, Mehmet Birhan Yilmaz⁴⁷, Shelley Zieroth⁴⁸, James Lay-Flurrie⁴⁹, Ilse van Gameren⁵⁰, Flaviana Amarante⁵¹, Prabhakar Viswanathan⁵², John J V McMurray²

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.

PMID: 38733212
DOI: 10.1002/ejhf.3266

Free article

Randomized Controlled Trial

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

Scott D Solomon et al. Eur J Heart Fail. 2024 Jun.

Free article

. 2024 Jun;26(6):1334-1346.

doi: 10.1002/ejhf.3266. Epub 2024 May 11.

Authors

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.

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.

Keywords: Clinical trials; Heart failure with mildly reduced or preserved ejection fraction; Mineralocorticoid receptor antagonists.

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References

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

Affiliations

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

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials

Miscellaneous