title: Assessment of quality of life during long-term treatment of tolvaptan in refractory heart failure: design and rationale of the AQUA-TLV study.
abstract: The vasopressin type 2 receptor antagonist tolvaptan (TLV) has recently become available to treat congestion in in-hospital patients with heart failure (HF). However, there is no evidence confirming the long-term efficacy of TLV. The Assessment of Quality of life during long-term treatment of TLV in refractory heart failure (AQUA-TLV) study is a multicenter, open-labeled, randomized, controlled clinical trial that will enroll 100 patients from 18 hospitals in Japan. Patients with HF assigned to New York Heart Association class III or IV, who had a previous history of hospitalization due to congestive HF during the past 1 year and ongoing symptomatic congestion with baseline urine osmolality > 350 mOsm/L regardless of being prescribed daily furosemide ≥ 60 mg are randomized to the conventional diuretics group (50 patients) and TLV add-on group (50 patients), and their quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire after 6 months of treatment. This study is the first multicenter prospective randomized study in Japan to evaluate the long-term clinical effectiveness of TLV compared with conventional treatment in patients with congestive HF (UMIN Clinical Trial Registry Number: UMIN 000009604).
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medicine, University of Tokyo.
authors.forename: Teruhiko
authors.initials: T
authors.lastname: Imamura
authors.forename: Koichiro
authors.initials: K
authors.lastname: Kinugawa
authors.forename: Tomohito
authors.initials: T
authors.lastname: Ohtani
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Sakata
authors.forename: Taiki
authors.initials: T
authors.lastname: Higo
authors.forename: Shintaro
authors.initials: S
authors.lastname: Kinugawa
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tsutsui
authors.forename: Kenji
authors.initials: K
authors.lastname: Sunagawa
authors.forename: Issei
authors.initials: I
authors.lastname: Komuro
mesh_terms: D000368:Aged; D065092:Antidiuretic Hormone Receptor Antagonists; D001552:Benzazepines / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy* / Q000523:psychology; D006760:Hospitalization / Q000639:trends; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D000077602:Tolvaptan; D016896:Treatment Outcome
chemical_list: D065092:Antidiuretic Hormone Receptor Antagonists; D001552:Benzazepines; D000077602:Tolvaptan