Effect of Long-Acting vs Short-Acting Loop Diuretics and Nurohormonal Blockers on Patients' Reported Quality of Life Among Patients with Heart Failure

• Project/Area Number: 21K16069
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 53020:Cardiology-related
• Research Institution: Jikei University School of Medicine
• Principal Investigator: 池村 修寛 東京慈恵会医科大学, 医学部, 特別研究員 (00896772)
• Project Period (FY): 2021-04-01 – 2023-03-31
• Project Status: Completed (Fiscal Year 2022)
• Budget Amount: ¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000); Fiscal Year 2024: ¥260,000 (Direct Cost: ¥200,000、Indirect Cost: ¥60,000); Fiscal Year 2023: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000); Fiscal Year 2022: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000); Fiscal Year 2021: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
• Keywords: 心不全 / アンギオテンシン受容体・ネプリライシン阻害薬 / SGLT2阻害薬 / 長時間作用型利尿薬 / 多施設ランダム化比較試験 / ファクトリアルデザイン / Registry based RCT / ランダム化比較試験 / ループ利尿薬 / 神経ホルモン調節薬

Outline of Research at the Start

現在の心不全治療において大きな議論を呼んでいる 1. ループ利尿薬の選択 および 2. 新規に認可された神経ホルモン調節薬の選択に関し、申請者が運営に携わるWest Tokyo Heart Failure Registry （WET-HF）を基盤とした2x2ファクトリアルデザインの Registry-based RCTを構築し、その有用性を並列的に検証することを主目的とする。

Outline of Annual Research Achievements

令和3年度より多施設心不全レジストリを基盤とした2×2ファクトリアルランダム化比較試験の実践を目的とした研究活動を開始した。研究計画書作成後、UMINに研究計画の登録を行なうと共に、各参加施設での実施許可の申請、ランダム化ソフトウェア、電子的データ入力システム（EDC）の開発を行った。また、臨床研究コーディネーター（CRC）の業務委託など の本研究の実施に向けた準備を進めた。 同年12月には参加施設に向けた説明会を複数回開催した。令和4年1月から慶應義塾大学病院での患者の登録を、2月より杏林大学病院、埼玉医科大学附属病院、東京慈恵会医科大学附属病院、3月より国立埼玉病院での登録を開始した。4月より、順次、実施許可申請及び臨床研究コーディネーターの業務委託契約を終えた共同研究機関での登録を開始し、済生会中央病院、東京医療センター、防衛医科大学病院、榊原記念病院、足利赤十字病院、川崎病院、浜松医科大学附属病院、そして国際医療福祉大学成田病院の合計１３施設で患者登録をおこなっている。報告書作成時点で、目標症例数の約８割の登録を終えた（212/240例）。令和5年6月頃に登録患者数が、目標症例数に達する予定であり、そこから半年のフォローアップ期間を経て、年度末には最終的な統計解析まで終える予定である。令和5年4月より、日本学術振興会 海外特別研究員として米国で多数のランダム化比較試験を実施しているMissouri University- Kansas City/Saint Luke's Mid America Heart InstituteのJohn Spertus教授の研究室での研究活動を予定しており、その方法論やデータ取得に関するノウハウを本研究課題にも活かす予定である。

Research Products

• [Journal Article] Time Trend in Incidence of Sudden Cardiac Death After Percutaneous Coronary Intervention from 2009 to 2017 (from the Japanese Multicenter Registry) (2023)
  • Author(s): Nakamaru Ryo、Shiraishi Yasuyuki、Niimi Nozomi、Ueda Ikuko、Ikemura Nobuhiro、Suzuki Masahiro、Noma Shigetaka、Inohara Taku、Numasawa Yohei、Fukuda Keiichi、Kohsaka Shun
  • Journal Title: The American Journal of Cardiology Volume: 188 Pages: 44-51
  • DOI: 10.1016/j.amjcard.2022.11.019
  • Peer Reviewed / Open Access
• [Journal Article] Left Ventricular Diastolic Indices and Their Impact on Outcomes in Patients with Recently Diagnosed Atrial Fibrillation (2022)
  • Author(s): Ikemura Nobuhiro、Nakanishi Koki、Spertus John A.、Lam Carolyn S. P.、Kimura Takehiro、Katsumata Yoshinori、Fujisawa Taishi、Ueda Ikuko、Ohki Takahiro、Fukuda Keiichi、Takatsuki Seiji、Kohsaka Shun
  • Journal Title: Journal of Clinical Medicine Volume: 11 Issue: 19 Pages: 5732-5732
  • DOI: 10.3390/jcm11195732
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Contrast-Associated Acute Kidney Injury After Percutaneous Coronary Intervention (2022)
  • Author(s): Ikemura Nobuhiro、Inohara Taku、Ueda Ikuko、Fukuda Keiichi、Kohsaka Shun
  • Journal Title: JACC: Cardiovascular Interventions Volume: 15 Issue: 12 Pages: 1283-1283
  • DOI: 10.1016/j.jcin.2022.04.027
  • Peer Reviewed
• [Journal Article] Machine learning models for prediction of adverse events after percutaneous coronary intervention (2022)
  • Author(s): Niimi Nozomi、Shiraishi Yasuyuki、Sawano Mitsuaki、Ikemura Nobuhiro、Inohara Taku、Ueda Ikuko、Fukuda Keiichi、Kohsaka Shun
  • Journal Title: Scientific Reports Volume: 12 Issue: 1
  • DOI: 10.1038/s41598-022-10346-1
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Effect of Tricuspid Regurgitation on the Reported Quality of Life and Subsequent Outcomes in Patients With Atrial Fibrillation (2022)
  • Author(s): Fujisawa Taishi、Kimura Takehiro、Ikemura Nobuhiro、Miyama Hiroshi、Katsumata Yoshinori、Ueda Ikuko、Tanimoto Kojiro、Kanki Hideaki、Fukuda Keiichi、Kohsaka Shun、Takatsuki Seiji
  • Journal Title: Journal of the American Heart Association Volume: 11 Issue: 8
  • DOI: 10.1161/jaha.121.022713
  • Peer Reviewed
• [Journal Article] Regional variations in the process of care for patients undergoing percutaneous coronary intervention in Japan. (2022)
  • Author(s): Shoji S, Yamaji K, Sandhu AT, Ikemura N, Shiraishi Y, Inohara T, Heidenreich PA, Amano T, Ikari Y, Kohsaka S.
  • Journal Title: Lancet Reg Heal - West Pacific Volume: 22 Pages: 100425-100425
  • DOI: 10.1016/j.lanwpc.2022.100425
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Catheter ablation improves outcomes and quality of life in Japanese patients with early-stage atrial fibrillation: A retrospective cohort study (2022)
  • Author(s): Seki Yuta、Fujisawa Taishi、Ikemura Nobuhiro、Ibe Susumu、Tsuzuki Ippei、Hashimoto Kenji、Yamashita Terumasa、Miyama Hiroshi、Niimi Nozomi、Suzuki Masahiro、Negishi Koji、Katsumata Yoshinori、Kimura Takehiro、Fukuda Keiichi、Kohsaka Shun、Takatsuki Seiji
  • Journal Title: Heart Rhythm Volume: 19 Issue: 7 Pages: 1076-1083
  • DOI: 10.1016/j.hrthm.2022.02.017
  • Peer Reviewed
• [Journal Article] Conventional medical therapy in heart failure patients eligible for the PARADIGM-HF, DAPA-HF, and SHIFT trials (2022)
  • Author(s): Satoshi Shoji, Shun Kohsaka, Yasuyuki Shiraishi, Takashi Kohno, Mitsuaki Sawano, Nobuhiro Ikemura, Nozomi Niimi, Yuji Nagatomo, Toshikazu D Tanaka, Makoto Takei, Tomohiko Ono, Munehisa Sakamoto, Shintaro Nakano, Iwao Nakamura, Soushin Inoue, Keiichi Fukuda, Tsutomu Yoshikawa
  • Journal Title: Int J Cardiol Volume: S0167-5273 Pages: 76-83
  • DOI: 10.1016/j.ijcard.2022.04.020
  • Peer Reviewed / Open Access
• [Journal Article] Implications of QRS Prolongation in Patients With Atrial Fibrillation (from a Multicenter Outpatient Registry) (2022)
  • Author(s): Miyama Hiroshi、Ikemura Nobuhiro、Kimura Takehiro、Katsumata Yoshinori、Fujisawa Taishi、Ueda Ikuko、Mitamura Hideo、Negishi Koji、Nagami Keiichi、Fukuda Keiichi、Kohsaka Shun、Takatsuki Seiji
  • Journal Title: The American Journal of Cardiology Volume: 178 Pages: 43-51
  • DOI: 10.1016/j.amjcard.2022.05.011
  • Peer Reviewed
• [Journal Article] Catheter ablation for patients with atrial fibrillation and heart failure with reduced and preserved ejection fraction: insights from the KiCS-AF multicentre cohort study (2022)
  • Author(s): Shiraishi Yasuyuki、Kohsaka Shun、Ikemura Nobuhiro、Kimura Takehiro、Katsumata Yoshinori、Tanimoto Kojiro、Suzuki Masahiro、Ueda Ikuko、Fukuda Keiichi、Takatsuki Seiji
  • Journal Title: EP Europace Volume: 25 Issue: 1 Pages: 83-91
  • DOI: 10.1093/europace/euac108
  • Peer Reviewed
• [Journal Article] Characteristics and health‐status outcomes in patients with atrial fibrillation detected via health screening (2022)
  • Author(s): Yamashita Terumasa、Kimura Takehiro、Ikemura Nobuhiro、Niimi Nozomi、Tsuzuki Ippei、Seki Yuta、Ibe Susumu、Hashimoto Kenji、Miyama Hiroshi、Fujisawa Taishi、Katsumata Yoshinori、Tanimoto Kojiro、Nagami Keiichi、Suzuki Masahiro、Kohsaka Shun、Fukuda Keiichi、Takatsuki Seiji
  • Journal Title: Clinical Cardiology Volume: 46 Issue: 1 Pages: 32-40
  • DOI: 10.1002/clc.23932
  • Peer Reviewed
• [Journal Article] Phenomapping in patients experiencing worsening renal function during hospitalization for acute heart failure (2021)
  • Author(s): Yagi Ryuichiro、Takei Makoto、Kohsaka Shun、Shiraishi Yasuyuki、Ikemura Nobuhiro、Shoji Satoshi、Niimi Nozomi、Higuchi Satoshi、Goda Ayumi、Kohno Takashi、Nagatomo Yuji、Nishihata Yosuke、Sujino Yasumori、Saji Mike、Ikegami Yukinori、Nakano Shintaro、Takahashi Toshiyuki、Fukuda Keiichi、Yoshikawa Tsutomu
  • Journal Title: ESC Heart Failure Volume: 8 Issue: 6 Pages: 5192-5203
  • DOI: 10.1002/ehf2.13598
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Burden of Mild (<13 g/dl) Anemia in Patients With Atrial Fibrillation (A Report from a Multicenter Registry With Patient-Reported Outcomes) (2021)
  • Author(s): Hashimoto Kenji、Kimura Takehiro、Ikemura Nobuhiro、Katsumata Yoshinori、Fujisawa Taishi、Miyama Hiroshi、Yamashita Terumasa、Nakamura Iwao、Mano Yoshinori、Oki Takahiro、Fukuda Keiichi、Kohsaka Shun、Takatsuki Seiji
  • Journal Title: The American Journal of Cardiology Volume: 157 Pages: 48-55
  • DOI: 10.1016/j.amjcard.2021.06.045
  • Peer Reviewed
• [Journal Article] Baseline and Postprocedural Health Status Outcomes in Contemporary Patients With Atrial Fibrillation Who Underwent Catheter Ablation: A Report from the Japanese Outpatient Registry (2021)
  • Author(s): Ikemura Nobuhiro、Spertus John A.、Kimura Takehiro、Katsumata Yoshinori、Fujisawa Taishi、Ueda Ikuko、Fukuda Keiichi、Takatsuki Seiji、Kohsaka Shun
  • Journal Title: Journal of the American Heart Association Volume: 10 Issue: 18
  • DOI: 10.1161/jaha.120.019983
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Letter by Kuno et al Regarding Article, “Heart Team/Guidelines Discordance Is Associated With Increased Mortality: Data From a National Survey of Revascularization in Patients With Complex Coronary Artery Disease” (2021)
  • Author(s): Kuno Toshiki、Ikemura Nobuhiro、Kohsaka Shun
  • Journal Title: Circulation: Cardiovascular Interventions Volume: 14 Issue: 7
  • DOI: 10.1161/circinterventions.121.010649
  • Peer Reviewed
• [Presentation] INTERNATIONAL COMPARISONS OF HEALTH STATUS OUTCOMES IN PATIENTS UNDERGOING INITIAL INVASIVE VERSUS CONSERVATIVE MANAGEMENT FOR CHRONIC CORONARY DISEASE: INSIGHTS FROM THE ISCHEMIA TRIAL (2023)
  • Author(s): Nobuhiro Ikemura, John A Spertus, Dan Nguyen, Zhuxuan Fu, Philip Jones, Harmony R Reynolds, Sripal Bangalore, Kreton Mavromatis, William E Boden, Fatima Rodriguez, Judith S Hochman, David Joel Maron
  • Organizer: ACC.23
  • Int'l Joint Research
• [Presentation] IMPACT OF FRAILTY ON CLINICAL OUTCOMES AFTER CORONARY ARTERY BYPASS GRAFTING VERSUS PERCUTANEOUS CORONARY INTERVENTION: INSIGHTS FROM SYNTAX (2023)
  • Author(s): Dan Nguyen, Nobuhiro Ikemura, Khaja Chinnakondepalli, Elizabeth Magnuson, Adam Christopher Salisbury, Patrick W Serruys, David J Cohen, Suzanne Arnold
  • Organizer: ACC.23
  • Int'l Joint Research
• [Presentation] The Importance of Assessment on the Patients' Health Status to Close the Gap to Care Providers (2022)
  • Author(s): 池村 修寛, 香坂 俊, 木村 雄弘, 勝俣 良紀, 植田 育子, 谷本 耕司郎, 鈴木 雅裕, 髙月 誠司, 福田 恵一
  • Organizer: 第86回 日本循環器学会 学術集会
• [Presentation] Association Between Baseline Health-Related Quality of Life and Subsequent Clinical Outcomes in Patients with Atrial Fibrillation (2021)
  • Author(s): Nobuhiro Ikemura, John Spertus, Takehiro Kimura, Yoshinori Katsumata, Taishi Fujisawa, Ikuko Ueda, Kojiro Tanimoto, masahiro suzuki, Keiichi Fukuda, Seiji Takatsuki, Shun Kohsaka
  • Organizer: AHA 2021
  • Int'l Joint Research
• [Presentation] Under-Utilization of Conventional Guideline-Directed Medical Therapy Among Patients Eligible for the Recent Large-Scale Clinical Trials of Heart Failure With Reduced Ejection Fraction (2021)
  • Author(s): Satoshi Shoji, Shun Kohsaka, Yasuyuki Shiraishi, Mitsuaki Sawano, Nobuhiro Ikemura, Nozomi Niimi, Takashi Kohno, Ayumi Goda, Yuji Nagatomo, Mike Saji, Makoto Takei, Shintaro Nakano, Keiichi Fukuda, Tsutomu Yoshikawa
  • Organizer: AHA 2021
  • Int'l Joint Research
• [Presentation] Incidence of Sudden Cardiac Death After Percutaneous Coronary Intervention (2021)
  • Author(s): Ryo Nakamaru, Nozomi Niimi, Taku Inohara, Yasuyuki Shiraishi, Nobuhiro Ikemura, Masahiro Suzuki, Shigetaka Noma, Yohei Numasawa, Keiichi Fukuda, Shun Kohsaka
  • Organizer: AHA 2021
  • Int'l Joint Research
• [Presentation] Duration of Disease and the Quality of Life of the Patients with Atrial Fibrillation (2021)
  • Author(s): Ryo Nakamaru, Nobuhiro Ikemura, John Spertus, Takehiro Kimura, Yoshinori Katsumata, Taishi Fujisawa, Hiroshi Miyama, Keiichi Fukuda, Seiji Takatsuki, Shun Kohsaka
  • Organizer: AHA 2021
  • Int'l Joint Research