NCT02644616已完成4 期
The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change of all the subjects'liquid intake and output volume change after a period(10 days) of treatment
研究概览
简要总结
The investigators research the early improvement of fluid retention and mid-term prognosis through the administration of tolvaptan for the patient with tricuspid regurgitation and right heart failure after left heart valves replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with tricuspid regurgitation and right heart failure after left heart valves replacement
- •Patients who takes existing diuretic
- •The patient is willing to participate in the study
排除标准
- •Patients with hypersensitivity to study drug
- •Anuric patients
- •Patients with hypernatremia
- •Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant
- •Malignant tumor
- •Patients with serious hepatic disorder or Serious Renal failure
- •Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
研究组 & 干预措施
trial group(tolvaptan group)
Active Comparator
trial group (tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv,n=20)
干预措施: tolvaptan+torasemide (Drug)
control group
Placebo Comparator
control group(placebo 15mg/d po(10 days) +torasemide 20mg/d iv,n=20)
干预措施: placebo+torasemide (Drug)
结局指标
主要结局
The change of all the subjects'liquid intake and output volume change after a period(10 days) of treatment
时间窗: 2015.01-2017.12
次要结局
- Onset of serious adverse event(all subjects)(2015.01-2017.12)
- A cumulative urine volume for 72 hours (all subjects)(2015.01-2017.12)
- other adverse events(all subjects)(2015.01-2017.12)
- Echocardiography results VS the baseline results(all subjects)(2015.01-2017.12)
- Change of right heart failure signs(all subjects)(2015.01-2017.12)
- Onset of cardiovascular event (all subjects)(2015.01-2017.12)
研究者
Yuan Fang
Principal Investigator
Shanghai Chest Hospital
研究点 (1)
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