Effect of Loop Diuretics Treatment on Blood Pressure Control in Phase 3-4 of Chronic Kidney Disease
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
- Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography
研究概览
简要总结
The purpose of this study is to verify the efficacy of diuretic therapy on blood pressure control and left ventricular mass in patients affected by chronic kidney disease
详细描述
In CKD, impairment of renal function causes fluid and sodium retention and consequently expansion of extracellular volume, which corresponds to about 5% of body weight in absence of peripheral edema. In particular, sodium retention increases exponentially as glomerular filtration rate declines and is of primary importance in the pathogenesis of hypertension. Therefore, reduction of salt intake in renal patients allows a better blood pressure control. Despite the evidence collected on the beneficial effects of salt restriction in CKD, compliance with dietary prescription is generally poor in patients followed up in the real world of clinical practice. In the presence of poor adherence to salt restriction, diuretics agents become the cornerstone of treatment of hypertension secondary to CKD. Disappointingly, nephrologists are reluctant to "adequately" use loop diuretics in their hypertensive CKD patients, probably because of the fear of side effects and of the amazing absence in medical literature of studies of middle-long term on diuretic efficacy. Therefore, the primary aim of this study is to evaluate efficacy and safety of loop diuretics on blood pressure control in patients affected by CKD.
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
- 否
入选标准
- •Chronic renal insufficiency in stage CKD 3 and 4 (GFR 60-15 ml/min/m2) estimated by Cockcroft-Gault formula corrected for body surface
- •Systolic blood pressure >140 mmHg in treatment with at least 1 class of antihypertensive drugs
- •Patients not in treatment from at least one month with loop diuretics
排除标准
- •Loop diuretics treatment
- •Variation of serum creatinine >30% in the last 3 months
- •Steroid therapy and/or cytotoxic agents
- •Edema syndromes (Nephrotic syndrome, cirrhosis, heart failure NYHA class 3 or 4)
- •Neoplasia
研究组 & 干预措施
Diuretic
Furosemide
干预措施: Furosemide (Drug)
结局指标
主要结局
Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography
时间窗: 6 months and 1 year respectively
次要结局
- Adverse drug reactions, ambulatory blood pressure measure control, body volumes evaluated by bioimpedance analysis, expense of time and resources in follow-up of patients(6 months)
