Document Detail

Assessment of quality of life during long-term treatment of tolvaptan in refractory heart failure: design and rationale of the AQUA-TLV study.
MedLine Citation:
PMID:  24806383     Owner:  NLM     Status:  MEDLINE    
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).
Teruhiko Imamura; Koichiro Kinugawa; Tomohito Ohtani; Yasushi Sakata; Taiki Higo; Shintaro Kinugawa; Hiroyuki Tsutsui; Kenji Sunagawa; Issei Komuro
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2014-05-07
Journal Detail:
Title:  International heart journal     Volume:  55     ISSN:  1349-3299     ISO Abbreviation:  Int Heart J     Publication Date:  2014  
Date Detail:
Created Date:  2014-05-26     Completed Date:  2014-07-22     Revised Date:  2014-08-06    
Medline Journal Info:
Nlm Unique ID:  101244240     Medline TA:  Int Heart J     Country:  Japan    
Other Details:
Languages:  eng     Pagination:  264-7     Citation Subset:  IM    
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MeSH Terms
Benzazepines / administration & dosage*
Dose-Response Relationship, Drug
Follow-Up Studies
Heart Failure / drug therapy*,  psychology
Hospitalization / trends
Middle Aged
Prospective Studies
Quality of Life*
Receptors, Vasopressin / antagonists & inhibitors
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Benzazepines; 0/Receptors, Vasopressin; 150683-30-0/tolvaptan

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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