Study protocol for the PURSUIT-HFpEF study: a Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection Fraction
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 i...
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2020-10-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Hiroyasu Iso |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-d20dfd3d103744c8ac77fa27e9d417a0 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-d20dfd3d103744c8ac77fa27e9d417a02025-08-20T02:26:10ZengBMJ Publishing GroupBMJ Open2044-60552020-10-01101010.1136/bmjopen-2020-038294Study protocol for the PURSUIT-HFpEF study: a Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection FractionHiroyasu Iso0Tetsuhisa Kitamura1Shinichiro Suna2Shungo Hikoso3Takahisa Yamada4Masaaki Uematsu5Yoshio Yasumura6Akito Nakagawa7Toshihiro Takeda8Takayuki Kojima9Hirota Kida10Bolrathanak Oeun11Akihiro Sunaga12Tomoharu Dohi13Katsuki Okada14Hiroya Mizuno15Daisaku Nakatani16Yasushi Matsumura17Yasushi Sakata18Oeun BolrathanakShunsuke Tamaki19Masatake FukunamiTakaharu Hayashi20Yoshiharu Higuchi21Masaharu MasudaMitsutoshi AsaiToshiaki ManoHisakazu Fuji22Daisaku MasudaYoshihiro TakedaYoshiyuki NagaiShizuya YamashitaMasami SairyoYusuke Nakagawa23Shuichi NozakiHaruhiko Abe24Yasunori UedaYukihiro Koretsune25Kunihiko NagaiMasamichi Yano26Masami NishinoJun TanouchiYoh AritaShinji HasegawaTakamaru IshizuMinoru IchikawaYuzuru TakanoEisai RinTetsuya WatanabeShiro Hoshida27Masahiro IzumiHiroyoshi YamamotoHiroyasu KatoKazuhiro NakataniHisatoyo HiraokaMayu NishioKeiji HirookaTakahiro YoshimuraYoshinori YasuokaAkihiro TaniYasushi OkumotoHideharu AkagiYasunaka MakinoToshinari OhnishiKatsuomi IwakuraNagahiro NishikawaYoshiyuki KijimaTakashi KitaoHideyuki KanaiWataru ShioyamaMasashi FujitaKoichiro HaradaMasahiro KumadaOsamu NakagawaRyo ArakiTakayuki Yamada28Takao MaruyamaFusako SeraKei NakamotoHidetaka KiokaTomohito Ohtani29Shirou Manabe3 Osaka Regional Center for Japan Environment and Children’s Study (JECS), Osaka University, Suita, Osaka, Japan4 Department of Social and Environmental Medicine, Osaka University Graduate School of Medicine, Suita, Japan1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan6 Division of Cardiology, Osaka General Medical Center, Osaka, JapanCardiovascular Division, National Hospital Organization Osaka National Hospital, Osaka, Japan9 Division of Cardiology, Amagasaki Chuo Hospital, Amagasaki, Japan1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, JapanDepartment of Medical Informatics, Osaka University Graduate School of Medicine, Osaka, JapanDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, JapanDepartment of Medical Informatics, Osaka University Graduate School of Medicine, Osaka, Japan1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan2 Department of Cardiology, Rinku General Medical Center, Izumisano, Japan8 Cardiovascular Division, Osaka Police Hospital, Osaka, JapanCardiovascular Division, Osaka Police Hospital, Osaka, Osaka, JapanCardiovascular Division, Kobe Ekisaikai Hospital, Kobe, Hyogo, Japan10 Division of Cardiology, Kawanishi City Medical Center, Kawanishi, JapanDepartment of Cardiovascular Medicine, National Hospital Organization Osaka National Hospital, Osaka, Osaka, JapanNational Hospital Organization Osaka National Hospital, Osaka, Japan7 Division of Cardiology, Osaka Rosai Hospital, Sakai, JapanDepartment of Cardiovascular Medicine, Yao Municipal Hospital, Yao, Osaka, Japan2 Department of Medicine, Division of Nephrology, University of Washington, Seattle, Washington, USA1 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, JapanIntroduction 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.https://bmjopen.bmj.com/content/10/10/e038294.full |
| spellingShingle | 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 Study protocol for the PURSUIT-HFpEF study: a Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection Fraction BMJ Open |
| title | Study protocol for the PURSUIT-HFpEF study: a Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection Fraction |
| title_full | Study protocol for the PURSUIT-HFpEF study: a Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection Fraction |
| title_fullStr | Study protocol for the PURSUIT-HFpEF study: a Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection Fraction |
| title_full_unstemmed | Study protocol for the PURSUIT-HFpEF study: a Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection Fraction |
| title_short | Study protocol for the PURSUIT-HFpEF study: a Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection Fraction |
| title_sort | study protocol for the pursuit hfpef study a prospective multicenter observational study of patients with heart failure with preserved ejection fraction |
| url | https://bmjopen.bmj.com/content/10/10/e038294.full |
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