Yuya Matsue1, Makoto Suzuki2, Sho Torii3, Satoshi Yamaguchi4, Seiji Fukamizu5, Yuichi Ono6, Hiroyuki Fujii7, Takeshi Kitai8, Toshihiko Nishioka9, Kaoru Sugi10, Yuko Onishi11, Makoto Noda12, Nobuyuki Kagiyama13, Yasuhiro Satoh14, Kazuki Yoshida15, Steven R Goldsmith16. 1. Department of Cardiology, Kameda Medical Center, Chiba, Japan. Electronic address: yuya8950@gmail.com. 2. Department of Cardiology, Kameda Medical Center, Chiba, Japan. 3. Department of Cardiology, Tokai University School of Medicine, Kanagawa, Japan. 4. Department of Cardiology, Tomishiro Central Hospital, Okinawa, Japan. 5. Department of Cardiology, Tokyo Metropolitan Hiroo Hospital, Tokyo, Japan. 6. Department of Cardiology, Ome Municipal General Hospital, Tokyo, Japan. 7. Department of Cardiology, Yokohama Minami Kyosai Hospital, Kanagawa, Japan. 8. Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan. 9. Department of Cardiology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan. 10. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan. 11. Department of Cardiology, Hiratsuka Kyosai Hospital, Kanagawa, Japan. 12. Department of Cardiology, Tokyo Yamate Medical Center, Tokyo, Japan. 13. Department of Cardiology, Sakakibara Heart Institute of Okayama, Okayama, Japan. 14. Department of Cardiology, National Disaster Medical Center, Tokyo, Japan. 15. Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA. 16. Division of Cardiology, Hennepin County Medical Center and University of Minnesota, Minneapolis, Minnesota, USA.
Abstract
BACKGROUND: More efficacious and/or safer decongestive therapy is clearly needed in acute heart failure (AHF) patients complicated by renal dysfunction. We tested the hypothesis that adding tolvaptan, an oral vasopressin-2 receptor antagonist, to conventional therapy with loop diuretics would be more effective treatment in this population. METHODS AND RESULTS: A multicenter, open-label, randomized control trial was performed, and 217 AHF patients with renal dysfunction (estimated glomerular filtration rate 15-60 mL • min(-1) • 1.73 m(-2)) were randomized 1:1 to treatment with tolvaptan (n=108) or conventional treatment (n=109). The primary end point was 48-hour urine volume. The tolvaptan group showed more diuresis than the conventional treatment group (6464.4 vs 4999.2 mL; P <.001) despite significantly lower amounts of loop diuretic use (80 mg vs 120 mg; P <.001). Dyspnea relief was achieved significantly more frequently in the tolvaptan group at all time points within 48 hours except 6 hours after enrollment. The rate of worsening of renal function (≥0.3 mg/dL increase from baseline) was similar between the tolvaptan and conventional treatment groups (24.1% vs 27.8%, respectively; P =.642). CONCLUSIONS: Adding tolvaptan to conventional treatment achieved more diuresis and relieved dyspnea symptoms in AHF patients with renal dysfunction. CLINICAL TRIAL REGISTRATION: URL: http://www.umin.ac.jp/ctr/index/htm/ Unique identifier: UMIN000007109.
RCT Entities:
BACKGROUND: More efficacious and/or safer decongestive therapy is clearly needed in acute heart failure (AHF) patients complicated by renal dysfunction. We tested the hypothesis that adding tolvaptan, an oral vasopressin-2 receptor antagonist, to conventional therapy with loop diuretics would be more effective treatment in this population. METHODS AND RESULTS: A multicenter, open-label, randomized control trial was performed, and 217 AHF patients with renal dysfunction (estimated glomerular filtration rate 15-60 mL • min(-1) • 1.73 m(-2)) were randomized 1:1 to treatment with tolvaptan (n=108) or conventional treatment (n=109). The primary end point was 48-hour urine volume. The tolvaptan group showed more diuresis than the conventional treatment group (6464.4 vs 4999.2 mL; P <.001) despite significantly lower amounts of loop diuretic use (80 mg vs 120 mg; P <.001). Dyspnea relief was achieved significantly more frequently in the tolvaptan group at all time points within 48 hours except 6 hours after enrollment. The rate of worsening of renal function (≥0.3 mg/dL increase from baseline) was similar between the tolvaptan and conventional treatment groups (24.1% vs 27.8%, respectively; P =.642). CONCLUSIONS: Adding tolvaptan to conventional treatment achieved more diuresis and relieved dyspnea symptoms in AHF patients with renal dysfunction. CLINICAL TRIAL REGISTRATION: URL: http://www.umin.ac.jp/ctr/index/htm/ Unique identifier: UMIN000007109.
Authors: Eva M Boorsma; Jozine M Ter Maaten; Kevin Damman; Wilfried Dinh; Finn Gustafsson; Steven Goldsmith; Daniel Burkhoff; Faiez Zannad; James E Udelson; Adriaan A Voors Journal: Nat Rev Cardiol Date: 2020-05-15 Impact factor: 32.419
Authors: Agata Bielecka-Dabrowa; Breno Godoy; Joerg C Schefold; Michael Koziolek; Maciej Banach; Stephan von Haehling Journal: Curr Heart Fail Rep Date: 2018-08