1
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      The characteristics and outcomes in patients with acute heart failure who used tolvaptan: from KCHF registry

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Aims

          The use of tolvaptan is increasing in clinical practice in Japan. However, the characteristics of patients who used tolvaptan and the timing of its use in patients with acute heart failure (AHF) are not fully elucidated.

          Methods and results

          Among consecutive 4056 patients in the Kyoto Congestive Heart Failure registry, we analysed 3802 patients after excluding patients on dialysis, prior or unknown tolvaptan use at admission, and unknown timing of tolvaptan use, and we divided them into two groups: tolvaptan use ( N = 773) and no tolvaptan use ( N = 3029). The prevalence of tolvaptan use varied widely from 48.7% to 0% across the participating centres. Factors independently associated with tolvaptan use were diabetes, poor medical adherence, oedema, pleural effusion, hyponatraemia, estimated glomerular filtration rate < 30 mL/min/1.73 m 2, moderate/severe tricuspid regurgitation, dobutamine infusion within 24 h, and additional inotropes infusion beyond 24 h after admission. The mortality rate at 90 days after admission was significantly higher in the tolvaptan use group than in the no tolvaptan use group (14.3% vs. 8.6%, P = 0.049). However, after adjustment, the excess mortality risk of tolvaptan use relative to no tolvaptan use was no longer significant (hazard ratio = 1.53, 95% confidence interval = 0.77–3.02, P = 0.22). Patients with tolvaptan use had a longer hospital stay [median (interquartile range): 22 (15–34) days vs. 15 (11–21) days, P < 0.0001] and a higher prevalence of worsening renal failure (47.0% vs. 31.8%, P < 0.0001) and worsening heart failure (24.8% vs. 14.4%, P < 0.0001) than those without.

          Conclusions

          AHF patients with tolvaptan use had more congestive status with poorer in‐hospital outcomes and higher short‐term mortality than those without tolvaptan use.

          Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02334891 (NCT02334891) and https://upload.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view.cgi?recptno=R000017241 (UMIN000015238).

          Related collections

          Most cited references29

          • Record: found
          • Abstract: not found
          • Article: not found

          2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.

            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

            The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, the Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiography recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST Outcome Trial.

              Vasopressin mediates fluid retention in heart failure. Tolvaptan, a vasopressin V2 receptor blocker, shows promise for management of heart failure. To investigate the effects of tolvaptan initiated in patients hospitalized with heart failure. The Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST), an event-driven, randomized, double-blind, placebo-controlled study. The outcome trial comprised 4133 patients within 2 short-term clinical status studies, who were hospitalized with heart failure, randomized at 359 North American, South American, and European sites between October 7, 2003, and February 3, 2006, and followed up during long-term treatment. Within 48 hours of admission, patients were randomly assigned to receive oral tolvaptan, 30 mg once per day (n = 2072), or placebo (n = 2061) for a minimum of 60 days, in addition to standard therapy. Dual primary end points were all-cause mortality (superiority and noninferiority) and cardiovascular death or hospitalization for heart failure (superiority only). Secondary end points included changes in dyspnea, body weight, and edema. During a median follow-up of 9.9 months, 537 patients (25.9%) in the tolvaptan group and 543 (26.3%) in the placebo group died (hazard ratio, 0.98; 95% confidence interval [CI], 0.87-1.11; P = .68). The upper confidence limit for the mortality difference was within the prespecified noninferiority margin of 1.25 (P<.001). The composite of cardiovascular death or hospitalization for heart failure occurred in 871 tolvaptan group patients (42.0%) and 829 placebo group patients (40.2%; hazard ratio, 1.04; 95% CI, 0.95-1.14; P = .55). Secondary end points of cardiovascular mortality, cardiovascular death or hospitalization, and worsening heart failure were also not different. Tolvaptan significantly improved secondary end points of day 1 patient-assessed dyspnea, day 1 body weight, and day 7 edema. In patients with hyponatremia, serum sodium levels significantly increased. The Kansas City Cardiomyopathy Questionnaire overall summary score was not improved at outpatient week 1, but body weight and serum sodium effects persisted long after discharge. Tolvaptan caused increased thirst and dry mouth, but frequencies of major adverse events were similar in the 2 groups. Tolvaptan initiated for acute treatment of patients hospitalized with heart failure had no effect on long-term mortality or heart failure-related morbidity. clinicaltrials.gov Identifier: NCT00071331
                Bookmark

                Author and article information

                Contributors
                tkato75@kuhp.kyoto-u.ac.jp
                Journal
                ESC Heart Fail
                ESC Heart Fail
                10.1002/(ISSN)2055-5822
                EHF2
                ESC Heart Failure
                John Wiley and Sons Inc. (Hoboken )
                2055-5822
                29 August 2023
                October 2023
                : 10
                : 5 ( doiID: 10.1002/ehf2.v10.5 )
                : 3141-3151
                Affiliations
                [ 1 ] Department of Cardiovascular Medicine Kyoto University Graduate School of Medicine 54 Shogoin Kawahara‐cho, Sakyo‐ku Kyoto Japan
                [ 2 ] Clinical Epidemiology Hyogo College of Medicine Nishinomiya Japan
                [ 3 ] Department of Cardiovascular Medicine Shiga General Hospital Moriyama Japan
                [ 4 ] Division of Cardiology Tenri Hospital Tenri Japan
                [ 5 ] Department of Cardiology Shizuoka General Hospital Shizuoka Japan
                [ 6 ] Department of Cardiovascular Medicine National Cerebral and Cardiovascular Center Suita Japan
                [ 7 ] Department of Cardiology Hyogo Prefectural Amagasaki General Medical Center Amagasaki Japan
                [ 8 ] Department of Cardiology National Hospital Organization Kyoto Medical Center Kyoto Japan
                [ 9 ] Department of Cardiology Osaka Red Cross Hospital Osaka Japan
                [ 10 ] Department of Cardiology Kishiwada City Hospital Kishiwada Japan
                [ 11 ] Department of Cardiology Kansai Electric Power Hospital Osaka Japan
                [ 12 ] Department of Cardiology Kurashiki Central Hospital Kurashiki Japan
                [ 13 ] Department of Cardiology Kokura Memorial Hospital Kitakyushu Japan
                [ 14 ] Department of Cardiology Japanese Red Cross Wakayama Medical Center Wakayama Japan
                [ 15 ] Department of Cardiovascular Medicine Kobe City Medical Center General Hospital Kobe Japan
                [ 16 ] Department of Cardiovascular Medicine Shinshu University Graduate School of Medicine Matsumoto Japan
                Author notes
                [*] [* ]Correspondence to: Takao Kato, MD, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara‐cho, Sakyo‐ku, Kyoto 606‐8507, Japan. Tel: +81‐75‐751‐4254; Fax: +81‐75‐751‐3289. Email: tkato75@ 123456kuhp.kyoto-u.ac.jp
                Article
                EHF214494 ESCHF-23-00376
                10.1002/ehf2.14494
                10567654
                37644779
                c009ba09-04cd-488b-b4c9-969b3c3f1eb3
                © 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 28 June 2023
                : 22 May 2023
                : 24 July 2023
                Page count
                Figures: 3, Tables: 3, Pages: 11, Words: 3461
                Funding
                Funded by: Japan Agency for Medical Research and Development , doi 10.13039/100009619;
                Award ID: 18059186
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                October 2023
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.3.4 mode:remove_FC converted:11.10.2023

                tolvaptan,heart failure,cohort study
                tolvaptan, heart failure, cohort study

                Comments

                Comment on this article