NCT01907958Unknown不适用
A Multicentre Study to Evaluate the Management of Microalbuminuria in Hypertensive Patients With Type 2 Diabetes: Improving Clinical Practice
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
- 否
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
研究点 (1)
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