Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in serum creatinine level, Patient and physician-assessed symptom scales at day 1, day 3, the end of week 1 and week 2
研究概览
简要总结
We designed this, randomized, double-blind, placebo-controlled trial to determine the clinical efficacy of chronic administration of prednisone on renal function and clinical status when added to standard care.
详细描述
Studies showed that glucocorticoids could specifically dilate renal vessel, increase in GFR, and regulate synthesis and release of atrial natriuretic peptide (ANP), upregulate ANP receptors on vascular endothelial cells, leading to significant diuresis and natriuresis. Adding glucocorticoids to standard care may potentiate the diuretic and natriuretic effects of diuretics and improve renal function, thus improve the clinical outcomes.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized with primary diagnosis of CHF
- •Patients with normal cortical function
- •LVEF <40%
- •Significant fluid overload, defined as ≥ 2 of the following
- •Enlarged liver or ascites
- •Peripheral or sacral edema ( ≥ 2+)
- •Jugular venous distention ≥ 10 cm
- •Pulmonary rales, pleural effusion on chest x-ray or orthopnea
排除标准
- •Severe stenotic valvular disease
- •Serum creatinine > 4 mg/dl
- •Patient refusal
- •Any signs of infection or any condition that would contraindicate an glucocorticoids use
- •Poor controlled hypertension
- •Poor controlled diabetes mellitus
- •Active myocarditis
- •Malignancy or other terminal illness
结局指标
主要结局
Change from baseline in serum creatinine level, Patient and physician-assessed symptom scales at day 1, day 3, the end of week 1 and week 2
次要结局
- Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile