Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With Right Heart Failure Caused by Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in urine volume (in milliliters）of 7 days after medication or discharge day(one earlier).
研究概览
简要总结
Efficacy and safety evaluation of tolvaptan in the treatment of patients with right heart failure caused by pulmonary arterial hypertension
详细描述
The study is a prospective, single-center, randomized controlled trial. Specifically, the research focuses on patients with right heart failure due to PAH in the Pulmonary Vascular Ward of Fuwai Hospital. Within 12 hours of admission, subjects were randomly assigned to two groups using the central randomization method. The dose of tolvaptan (15 mg/d) is added to standard therapy (including diuretics) for subjects in group A. Traditional standard therapy (including diuretics) is used for subjects in group B. The treatment lasts for a total of seven days to assess the efficacy and safety of tolvaptan in the treatment of PAH-induced right heart failure. An informed consent form must be signed by each participant in our study.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 是
入选标准
- •Patients who have no serious cerebrovascular, liver, kidney and lung organ and tissue diseases.
- •No corticosteroids or immunosuppressive agents had been administered to the - Patients in the three months prior to enrollment in the study.
- •Patients voluntarily participated in the study and signed an informed consent form.
排除标准
- •Patients who install the circulation aids.
- •Patients who have been diagnosed with active myocarditis or amyloid cardiomyopathy.
- •Fasting blood glucose level exceeded 12.21 mmol/L in individuals with uncontrolled diabetes.
- •Patients who suffer from anuria, urethral strictures, stones, or tumors caused by urination disorders.
- •Patients with acute myocardial infarctions, persistent ventricular tachycardias, or ventricular fibrillations, and cerebrovascular accidents within the first 30 days of the screening period.
- •Patients with a history of allergy or specific reactions to benzodiazepines. (Mozavaputan hydrochloride, Benaepril hydrochloride)
- •Any of the following laboratory tests were abnormal: serum creatinine> 2.5 times the upper normal value limit, serum sodium> 145 mmol/L, and serum potassium> 5.5 mmol/L.
- •Pregnant women, lactating women, or patients who may be pregnant or have pregnancy plans.
- •Patients with other contraindications to the use of tolvaptan.
- •Patients who have been taking tolvaptan within the first 3 months before inclusion in the study, either when the drug was marketed or when it was being clinically studied.
- •Additionally, patients who were judged by the investigators not fit to be enrolled in this trial.
研究组 & 干预措施
Subjects in group A
For subjects in group A, tolvaptan (15 mg/d) is added to standard therapy (furosemide: 20mg-40mg/d).
干预措施: Tolvaptan (Drug)
Subjects in group A
For subjects in group A, tolvaptan (15 mg/d) is added to standard therapy (furosemide: 20mg-40mg/d).
干预措施: Furosemide (Drug)
Subjects in group B
Subjects in group B receive standard therapy (including furosemide: 20mg-40mg/d).
干预措施: Furosemide (Drug)
结局指标
主要结局
Changes in urine volume (in milliliters）of 7 days after medication or discharge day(one earlier).
时间窗: 7 days
Changes in urine volume ( in milliliters ) of 7 days after medication or discharge day(one earlier).
Changes in body weight( in kilograms ) of 7 days after medication or discharge day(one earlier).
时间窗: 7 days
Changes in body weight ( in kilograms ) of 7 days after medication or discharge day(one earlier).
次要结局
- Blood creatinine changes in renal function.(7 days)