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Rationale and Design of the Multicenter Trial on Japan Working Group on the Effects of Angiotensin Receptor Blockers Selection (Azilsartan vs. Candesartan) on Diastolic Function in the Patients Suffering from Heart Failure with Preserved Ejection Fraction: J-TASTE Trial

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Abstract

Background

Previous studies suggest that the pathophysiology of heart failure with preserved ejection fraction (HFpEF) is characterized not only by high ventricular stiffness, but also by vascular stiffness. Azilsartan has higher vascular affinity compared with other angiotensin II receptor blockers (ARBs), which were proven to have no beneficial effects on clinical outcomes in patients with HFpEF in earlier clinical trials. We aimed to test the hypothesis that azilsartan may improve left ventricular diastolic function in HFpEF patients with hypertension in this trial.

Methods

The Effects of Angiotensin Receptor Blockers on Diastolic Function in Patients Suffering from Heart Failure with Preserved Ejection Fraction: J-TASTE trial is a multicenter, randomized, open-labeled, and assessor(s)-blinded, active controlled using candesartan, parallel-group clinical trial, to compare changes in left ventricular (LV) diastolic dysfunction between HFpEF patients with hypertension who have received candesartan or azilsartan for 48 weeks. The primary endpoint is the change in early diastolic wave height/early diastolic mitral annulus velocity (E/e’) assessed by echocardiography from the baseline to the end of the study (48 weeks). A total of 190 patients will be recruited into the study.

Conclusions

The design of the J-TASTE trial will provide data on whether differences between the effects of the two tested drugs on LV diastolic function exist in HFpEF patients with hypertension and will improve understanding of the pathophysiological role of vascular stiffness on diastolic function.

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Author information

Authors and Affiliations

  1. Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, 565-8565, Japan

    Hiroyuki Takahama & Toshihisa Anzai

  2. Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Center, Suita, 565-8565, Japan

    Masanori Asakura & Masafumi Kitakaze

  3. Hyogo Medical College, Nishinomiya, Japan

    Masanori Asakura

  4. Osaka City General Hospital, Osaka, Japan

    Yukio Abe

  5. Tosei Hospital, Seto, Japan

    Masayoshi Ajioka

  6. Tsukuba University Medical School, Tsukuba, Japan

    Kazutaka Aonuma

  7. Hokkaido University Graduate School of Medicine, Sapporo, Japan

    Toshihisa Anzai

  8. Osaka Police Hospital, Osaka, Japan

    Takaharu Hayashi

  9. Hiramitsu Heart Clinic, Nagoya, Japan

    Shinya Hiramitsu

  10. Hyogo Brain and Heart Center at Himeji, Himeji, Japan

    Hiroya Kawai

  11. Osaka University Graduate School of Medicine, Suita, Japan

    Hidetaka Kioka

  12. Cardiovascular Center, Yokohama City University General Medical Center, Yokohama, Japan

    Kazuo Kimura

  13. Kawachi General Hospital, Higashi-Osaka, Japan

    Young-Jae Lim

  14. Yoshikawa Hospital, Sakai, Japan

    Ken Matsuoka

  15. Shinshu University School of Medicine, Matsumoto, Japan

    Hirohiko Motoki

  16. Kanazawa University Graduate School of Medicine, Kanazawa, Japan

    Yoji Nagata

  17. Shin-Tokyo Heart Clinic, Matsudo, Japan

    Sunao Nakamura

  18. Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

    Nobuyuki Ohte

  19. Fujita Health University School of Medicine, Toyoake, Japan

    Yukio Ozaki

  20. Wanabe Hospital, Okegawa, Japan

    Taishi Sasaoka

  21. Osaka General Medical Center, Osaka, Japan

    Shunsuke Tamaki

  22. Department of Data Science, Department of Advanced Medical Technology Development, National Cerebral and Cardiovascular Center, Suita, 565-8565, Japan

    Toshimitsu Hamasaki

Authors
  1. Hiroyuki Takahama
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  2. Masanori Asakura
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  3. Yukio Abe
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  16. Sunao Nakamura
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  22. Masafumi Kitakaze
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Corresponding author

Correspondence to Masafumi Kitakaze.

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Conflict of Interest

H.T. reports grants from The Bayer Scholarship for Cardiovascular Research; grants from Japan Ministry of Education, Culture, Sports, Science and Technology; personal fees from Otsuka; personal fees from Ono Pharmaceutical Co.; and personal fees from Daiichi Sankyo. M. K. reports grants and personal fees from Takeda, during the conduct of the study, and grants from Japanese government; grants from Japan Heart Foundation; grants from Japan Cardiovascular Research Foundation; grants and personal fees from Asteras; grants and personal fees from Sanofi; personal fees from Daiichi Sankyo; grants and personal fees from Pfizer; grants and personal fees from Ono; personal fees from Bayer; grants and personal fees from Novartis; personal fees from Behringer; grants and personal fees from Tanabe Mitsubishi; personal fees from Kowa; grants and personal fees from Kyowa Hakko Kirin; personal fees from Dainippon Sumitomo; personal fees from Sawai; personal fees from MSD; grants and personal fees from Abbott; grants and personal fees from Otsuka; grants from Calpis; grants from Nihon Kohden; personal fees from Shionogi; personal fees from AstraZeneca; personal fees from Asahi Kasei Med.; personal fees from Novo Nordisk; personal fees from Fujifilm RI; and personal fees from Japan Medical Data. Dr. Asakura reports grants from Actelion Pharmaceutical Japan; grants from Boehringer Ingelheim Japan, Inc.; personal fees from Otsuka Pharmaceutical Co., Ltd.; personal fees from Sanofi K.K.; personal fees from Bayer Yakuhin, Ltd.; personal fees from MSD K.K.; personal fees from Takeda Pharmaceutical Company Limited; personal fees from Ono Pharmaceutical Co., LTD.; personal fees from Mitsubishi Tanabe Pharma Corporation; personal fees from Daiichi Sankyo; personal fees from Pfizer Japan Inc.; and personal fees from Astellas Amgen Biopharma, outside the submitted work. Dr. Abe reports grants from Teijin, grants from Abbott, grants from Shionogi, grants and personal fees from Daiichi Sankyo, grants and personal fees from Bayer, grants and personal fees from Bristol-Myers Squibb, grants from Ono, grants from Novartis, grants from Pfizer, personal fees from Toa Eiyo, personal fees from Boehringer Ingelheim, personal fees from Dainippon Sumitomo, personal fees from Otsuka, personal fees from Philips, personal fees from GE, personal fees from Siemens, and grants from Japanese government, outside the submitted work. Dr. Ajioka has nothing to disclose. Dr. Aonuma has nothing to disclose. Dr. Anzai has nothing to disclose. Dr. Hayashi has nothing to disclose. Dr. Hiramitsu reports personal fees from null, during the conduct of the study, and personal fees from Tanabe Mitsubishi; personal fees from Daiichi Sankyo; personal fees from Bayer; personal fees from Takeda; personal fees from Asteras; personal fees from MSD; and personal fees from Kowa, from null, outside the submitted work. Dr. Kawai has nothing to disclose. Dr. Kioka has nothing to disclose. Dr. Kimura has nothing to disclose. Dr. Lim has nothing to disclose. Dr. Matsuoka has nothing to disclose. Dr. Motoki has nothing to disclose. Dr. Nagata has nothing to disclose. Dr. Nakamura has nothing to disclose. Dr. Ohte has nothing to disclose. Dr. Ozaki has nothing to disclose. Dr. Sasaoka has nothing to disclose. Dr. Tamaki reports non-financial support from Bristol-Myers Squibb Company, non-financial support from Eli Lilly and Company, non-financial support from Otsuka Pharmaceutical, non-financial support from Boehringer Ingelheim, non-financial support from Toa Eiyo, non-financial support from Nihon Medi-Physics, non-financial support from Medtronic, and non-financial support from Nikkei Business Publications, outside the submitted work. Dr. Hamasaki has nothing to disclose. Dr. Kitakaze reports grants from Japanese government, during the conduct of the study, and grants from Japanese government; grants from Japan Heart Foundation; grants from Japan Cardiovascular Research Foundation; grants and personal fees from Asteras; personal fees from Daiichi Sankyo; grants and personal fees from Pfizer; grants and personal fees from Ono; personal fees from Bayer; grants from Novartis; grants and personal fees from Tanabe Mitsubishi; personal fees from Kowa; personal fees from MSD; grants from Nihon Kohden; personal fees from Shionogi; personal fees from Astrazeneca; grants and personal fees from Astra Zeneca; personal fees from Taisho Toyama; personal fees from Toyama Kagaku; grants and personal fees from Kureha; and personal fees from Toa Eiyo, outside the submitted work.

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Persons from Takeda Pharmaceutical Company Limited will not be involved in conducting this study and analysis, and intentions of Takeda Pharmaceutical Company Limited will not be reflected in the results and interpretations of this study.

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Takahama, H., Asakura, M., Abe, Y. et al. Rationale and Design of the Multicenter Trial on Japan Working Group on the Effects of Angiotensin Receptor Blockers Selection (Azilsartan vs. Candesartan) on Diastolic Function in the Patients Suffering from Heart Failure with Preserved Ejection Fraction: J-TASTE Trial. Cardiovasc Drugs Ther 32, 381–388 (2018). https://doi.org/10.1007/s10557-018-6799-5

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