Assessment of Quality of Life During Long-Term Treatment of Tolvaptan in Refractory Heart Failure Design and Rationale of the AQUA-TLV Study
Assessment of Quality of Life During Long-Term Treatment of Tolvaptan in Refractory Heart Failure Design and Rationale of the AQUA-TLV Study
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DOI：
10.1536/ihj.13-326
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发表时间：
2014-05-01
影响因子：
1.5
通讯作者：
Komuro, Issei
中科院分区：
文献类型：
--
作者：
Imamura, Teruhiko;Kinugawa, Koichiro;Komuro, Issei
血管加压素2型受体拮抗剂托伐普坦（TLV）最近已可用于治疗心力衰竭（HF）住院患者的充血。然而，没有证据证实TLV的长期疗效。TLV长期治疗难治性心力衰竭期间的生活质量评估（AQUA-TLV）研究是一项多中心、开放标签、随机、对照临床试验，将从日本18家医院入组100例患者。将被分为纽约心脏协会III级或IV级的HF患者随机分配到常规利尿剂组，这些患者在过去1年内有因充血性HF住院的既往病史，并且无论是否每日处方呋塞米≥ 60 mg，基线尿渗透压> 350 mOsm/L的持续症状性充血治疗6个月后，采用明尼苏达心力衰竭生活质量问卷（Minnesota Living with Heart Failure Questionnaire）评估患者的生活质量。本研究是日本第一项多中心前瞻性随机研究，旨在评价TLV与常规治疗相比在充血性HF患者中的长期临床有效性。
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.