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Home telemonitoring study for Japanese patients with heart failure (HOMES-HF): protocol for a multicentre randomised controlled trial
  1. Norihiko Kotooka1,
  2. Machiko Asaka1,
  3. Yasunori Sato2,
  4. Yoshiharu Kinugasa3,
  5. Kotaro Nochioka4,
  6. Atsushi Mizuno5,
  7. Daisuke Nagatomo1,
  8. Daigo Mine6,
  9. Yoko Yamada7,
  10. Kazuo Eguchi8,
  11. Hideki Hanaoka2,
  12. Takayuki Inomata9,
  13. Yoshihiro Fukumoto4,
  14. Kazuhiro Yamamoto3,
  15. Hiroyuki Tsutsui10,
  16. Tohru Masuyama11,
  17. Masafumi Kitakaze12,
  18. Teruo Inoue13,
  19. Hiroaki Shimokawa4,
  20. Shin-ichi Momomura7,
  21. Yoshihiko Seino14,
  22. Koichi Node1,
  23. on behalf of the HOMES-HF study investigators
  1. 1Department of Cardiovascular Medicine, Saga University, Saga, Japan
  2. 2Chiba University Hospital Clinical Research Center, Chiba University, Chiba, Japan
  3. 3Division of Cardiolovascular Medicine, Department of Molecular Medicine and Therapeutics, Tottori University, Yonago, Japan
  4. 4Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan
  5. 5Department of Cardiology, St. Luke's International Hospital, Tokyo, Japan
  6. 6Department of Cardiology, Saga Prefectural Hospital Koseikan, Saga, Japan
  7. 7Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Omiya, Japan
  8. 8Department of Medicine, Division of Cardiovascular Medicine, Jichi Medical University, Shimotsuke, Japan
  9. 9Department of Cardio-Angiology, Kitasato University School of Medicine, Sagamihara, Japan
  10. 10Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan
  11. 11Cardiovascular Division, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
  12. 12Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan
  13. 13Department of Cardiovascular Medicine, Dokkyo Medical University, Mibu, Japan
  14. 14Department of Cardiology, Nippon Medical School Chiba-Hokusoh Hospital, Inzai, Japan
  1. Correspondence to Dr Norihiko Kotooka; kotooka{at}


Introduction Despite the encouraging results from several randomised controlled trials (RCTs) and meta-analyses, the ability of home telemonitoring for heart failure (HF) to improve patient outcomes remains controversial as a consequence of the two recent large-scale RCTs. However, it has been suggested that there is a subgroup of patients with HF who may benefit from telemonitoring. The aim of the present study was to investigate whether an HF management programme using telemonitoring could improve outcomes in patients with HF under the Japanese healthcare system.

Methods and analysis The Home Telemonitoring Study for Japanese Patients with Heart Failure (HOMES-HF) study is a prospective, multicentre RCT to investigate the effectiveness of home telemonitoring on the primary composite endpoint of all-cause death and rehospitalisation due to worsening HF in recently admitted HF patients (aged 20 and older, New York Heart Association classes II–III). The telemonitoring system is an automated physiological monitoring system including body weight, blood pressure and pulse rate by full-time nurses 7 days a week. Additionally, the system was designed to make it a high priority to support patient's self-care instead of an early detection of HF decompensation. A total sample size of 420 patients is planned according to the Schoenfeld and Richter method. Eligible patients are randomly assigned via a website to either the telemonitoring group or the usual care group by using a minimisation method with biased-coin assignment balancing on age, left ventricular ejection fraction and a history of ischaemic heart disease. Participants will be enrolled until August 2013 and followed until August 2014. Time to events will be estimated using the Kaplan-Meier method, and HRs and 95% CIs will be calculated using the Cox proportional hazards models with stratification factors.

Trial Registration: The study is registered at UMIN Clinical Trials Registry (UMIN000006839).

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: and

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