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临床试验/NCT01907958
NCT01907958Unknown不适用

A Multicentre Study to Evaluate the Management of Microalbuminuria in Hypertensive Patients With Type 2 Diabetes: Improving Clinical Practice

Medpharmgene, Inc.1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
280
试验地点
1
主要终点
Stabilisation or improvement of urine albumin excretion status by at least one stage

研究概览

简要总结

Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin to usual practice on quality of care in hypertensive patients with Type 2 diabetes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Male or female 18 years and older and able to visit the study sites every 3 months
  • T2D patients with ongoing anti-diabetic therapy for at least 5 years
  • Uncontrolled hypertension according to 2012 CHEP recommendations for management of hypertension in diabetic patients ( i.e. BP> 130/80 mmHg)
  • Able and agreeing to provide informed consent.

排除标准

  • Type 1 diabetes patients
  • Ongoing therapy with perindopril,
  • Known hypersensitivity or allergies to ACEI or sulfonamide derivatives,
  • A history of angioedema related or not to previous treatment with ACEI,
  • Impaired renal function defined as serum creatinine levels > 177 µmol/L, eGFR <30 mL/min,
  • Hyperkalemia or hypokalemia,
  • Severe hepatic impairment,
  • Use of non-antiarrhythmic agents causing torsade de pointes,
  • Pregnant or lactating women, or who are planning to become pregnant,
  • Any conditions which may impact on participation according to treating physician.

结局指标

主要结局

Stabilisation or improvement of urine albumin excretion status by at least one stage

时间窗: 1 year

次要结局

  • Microalbuminuria (or further stages of CKD) after 12 months(12 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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