Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Daily urinary volumes
研究概览
简要总结
The purpose of this study is to examine the efficacy of three doses of prednisone, a glucocorticoid, in treatment of patients with symptomatic heart failure.
详细描述
Heart failure is a leading cause of cardiovascular morbidity and mortality in the world. Most patients with acute symptomatic heart failure are admitted with fluid overload. Intravenous loop diuretics are an essential component of current treatment in such patients. Newly emerging evidence showed that glucocorticoids could potentiate natriuretic peptides' action by upregulating the expression natriuretic peptide receptor A (NPR-A) in the kidney, and produce a potent diuresis. Therefore, the investigators designed this nonblinded, randomized dose comparison study to compare the efficacy of prednisone at 15, 30 and 60 mg/day in patients with in symptomatic heart failure.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospitalized for symptomatic heart failure
- •dyspnea at rest or with minimal activity
- •NT-proBNP > 1000pg/ml
- •LVEF ≤ 40%
排除标准
- •any condition (other than CHF) that could limit the use of prednisone;
- •acute decompensated heart failure
- •active myocarditis
- •obstructive or restrictive cardiomyopathy
- •cardiac surgery within previous 3 months
- •acute coronary syndrome
研究组 & 干预措施
30 mg prednisone group
The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day.
干预措施: prednisone (Drug)
60 mg prednisone group
The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day.
干预措施: prednisone (Drug)
15 mg prednisone group
The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.
干预措施: prednisone (Drug)
结局指标
主要结局
Daily urinary volumes
时间窗: 10 days
Daily urinary volumes will be monitored for 10 days.
Urinary sodium excretion
时间窗: 10 days
Daily sodium exretions will be assessed at baseline, day 5 and day 10.
次要结局
- The effect of prednisone on renin angiotensin aldosterone system.(10 days)
研究者
Kun-shen Liu M.D.
Professor
Hebei Medical University