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临床试验/NCT00478543
NCT00478543已完成4 期

Effect of Loop Diuretics Treatment on Blood Pressure Control in Phase 3-4 of Chronic Kidney Disease

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年9月最近更新:
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
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

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

Experimental

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)

研究者

申办方类型
Other

研究点 (1)

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