BMJ Open (Oct 2020)

Study protocol for the PURSUIT-HFpEF study: a Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection Fraction

  • Hiroyasu Iso,
  • Tetsuhisa Kitamura,
  • Shinichiro Suna,
  • Shungo Hikoso,
  • Takahisa Yamada,
  • Masaaki Uematsu,
  • Yoshio Yasumura,
  • Akito Nakagawa,
  • Toshihiro Takeda,
  • Takayuki Kojima,
  • Hirota Kida,
  • Bolrathanak Oeun,
  • Akihiro Sunaga,
  • Tomoharu Dohi,
  • Katsuki Okada,
  • Hiroya Mizuno,
  • Daisaku Nakatani,
  • Yasushi Matsumura,
  • Yasushi Sakata,
  • Oeun Bolrathanak,
  • Shunsuke Tamaki,
  • Masatake Fukunami,
  • Takaharu Hayashi,
  • Yoshiharu Higuchi,
  • Masaharu Masuda,
  • Mitsutoshi Asai,
  • Toshiaki Mano,
  • Hisakazu Fuji,
  • Daisaku Masuda,
  • Yoshihiro Takeda,
  • Yoshiyuki Nagai,
  • Shizuya Yamashita,
  • Masami Sairyo,
  • Yusuke Nakagawa,
  • Shuichi Nozaki,
  • Haruhiko Abe,
  • Yasunori Ueda,
  • Yukihiro Koretsune,
  • Kunihiko Nagai,
  • Masamichi Yano,
  • Masami Nishino,
  • Jun Tanouchi,
  • Yoh Arita,
  • Shinji Hasegawa,
  • Takamaru Ishizu,
  • Minoru Ichikawa,
  • Yuzuru Takano,
  • Eisai Rin,
  • Tetsuya Watanabe,
  • Shiro Hoshida,
  • Masahiro Izumi,
  • Hiroyoshi Yamamoto,
  • Hiroyasu Kato,
  • Kazuhiro Nakatani,
  • Hisatoyo Hiraoka,
  • Mayu Nishio,
  • Keiji Hirooka,
  • Takahiro Yoshimura,
  • Yoshinori Yasuoka,
  • Akihiro Tani,
  • Yasushi Okumoto,
  • Hideharu Akagi,
  • Yasunaka Makino,
  • Toshinari Ohnishi,
  • Katsuomi Iwakura,
  • Nagahiro Nishikawa,
  • Yoshiyuki Kijima,
  • Takashi Kitao,
  • Hideyuki Kanai,
  • Wataru Shioyama,
  • Masashi Fujita,
  • Koichiro Harada,
  • Masahiro Kumada,
  • Osamu Nakagawa,
  • Ryo Araki,
  • Takayuki Yamada,
  • Takao Maruyama,
  • Fusako Sera,
  • Kei Nakamoto,
  • Hidetaka Kioka,
  • Tomohito Ohtani,
  • Shirou Manabe

DOI
https://doi.org/10.1136/bmjopen-2020-038294
Journal volume & issue
Vol. 10, no. 10

Abstract

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Introduction Neither the pathophysiology nor an effective treatment for heart failure with preserved ejection fraction (HFpEF) has been elucidated to date. The purpose of this ongoing study is to elucidate the pathophysiology and prognostic factors for patients with HFpEF admitted to participating institutes. We also aim to obtain insights into the development of new diagnostic and treatment methods by analysing patient background factors, clinical data and follow-up information.Methods and analysis This study is a prospective, multicentre, observational study of patients aged ≥20 years admitted due to acute decompensated heart failure with preserved left ventricular ejection fraction (≥50%) and elevated N-terminal-pro brain natriuretic peptide (NT-proBNP) (≥400 pg/mL). The study began in June 2016, with the participation of Osaka University Hospital and 31 affiliated facilities. We will collect data on history in detail, accompanying diseases, quality of life, frailty score, medication history, and laboratory and echocardiographic data. We will follow-up each patient for 5 years, and collect outcome data on mortality, cause of death, and the number and cause of hospitalisation. The target number of registered cases is 1500 cases in 5 years.Ethics and dissemination The protocol was approved by the Institutional Review Board (IRB) of Osaka University Hospital on 24 February 2016 (ID: 15471), and by the IRBs of the all participating facilities. The findings will be disseminated through peer-reviewed publications and conference presentations.