DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- 24 hour blood pressure
研究概览
简要总结
In this clinical study the anti-hypertensive response to dietary salt restriction is compared with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in adult patients with chronic kidney disease.
详细描述
Patients with chronic kidney disease (CKD) are exquisitely salt-sensitive. Salt-sensitivity in CKD is linked to hypertension and cardiovascular outcomes. Dietary salt restriction is an accepted intervention for salt-sensitivity in CKD. Another strategy, however, could be to block sodium uptake by the kidney pharmacologically by diuretics. Especially diuretics acting on the distal tubule may be effective, because this appears to be the site of increased sodium reabsorption in CKD. It is currently unknown how these two strategies, diet or diuretics, relate. The investigators hypothesize that diuretics are non-inferior to diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •CKD stage 3 or 4 (MDRD-GFR 15-60 ml/min)
- •Use of any anti-hypertensive drugs
- •No anti-hypertensive drugs but an average office systolic blood pressure > 140 mmHg (as measured by datascope)
排除标准
- •Salt-wasting CKD
- •Nephrotic syndrome
- •Pregnant or breastfeeding women
- •Life expectancy < 6 months
- •Severe heart failure (NYHA III or IV) or liver cirrhosis with ascites and the inability to withdraw diuretics
- •Rapidly declining kidney function with high likelihood of dialysis or kidney transplantation in the coming 4 months
- •Kidney transplant recipients
- •Use of immunosuppressive drugs
- •Use of non-steroidal anti-inflammatory drugs
- •Previous intolerance or allergy to hydrochlorothiazide or amiloride
- •Serum sodium < 135 mmol/l
- •Serum potassium < 3.5 mmol/l or > 5.0 mmol/l
- •Inability to adhere to the study protocol (due to language, incapacitated subjects, subjects with intellectual disability)
研究组 & 干预措施
Diuretic treatment
Patients receive amiloride and hydrochlorothiazide
干预措施: Amiloride (Drug)
Diuretic treatment
Patients receive amiloride and hydrochlorothiazide
干预措施: Hydrochlorothiazide (Drug)
Low-sodium diet
Patients are put on a low-sodium diet (60 mmol/day)
干预措施: Low-sodium diet (Other)
结局指标
主要结局
24 hour blood pressure
时间窗: Two weeks after start of each intervention
次要结局
未报告次要终点
研究者
Ewout Hoorn
Internist nephrologist
Erasmus Medical Center