The Role of Renal and Peripheral Vascular Resistance in Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Change in glomerular filtration rate between the two treatment arms.
研究概览
简要总结
Patients with reduced kidney function have a higher risk of heart disease and death. Studies have shown that blood vessels in patients with hypertension change with a decrease of lumen size and growth of the vessel wall. By treating patients with antihypertensive certain medication vessel lumen and walls normalize. Treating hypertension in patients with chronic kidney disease slows the progression of kidney function loss.
The aim is to compare different degrees of antihypertensive medication in patients with chronic kidney disease and hypertension will slow the progression of kidney loss.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •eGFR 15-60 ml/min for at least 3 months
- •Blood pressure > 130 mmHg systolic og >80 mmHg diastolic (patients without antihypertensive treatment or in treatment with Beta-blockers, ACEi, ARBs or CCB not in maximum dosi).
- •Blood pressure < 130 mmHg systolic og < 80 mmHg diastolic (patients receiving Beta-blockers, ACEi, ARBs og CCB).
- •Fertile women using safe contraceptives
排除标准
- •Ultrasound verified Polycystic Kidney Disease (ADPKD)
- •Claustrophobia (MRi scan).
- •Contraindications to MRi.
- •Pregnancy or wish to become pregnant in the study period.
- •Nephrotic syndrome with gross edema.
- •Known allergy to any study medication.
- •Blood pressure < 130 mmHg systolic or < 80 mmHg diastolic without antihypertensive treatment.
- •Blood pressure > 130 mmHg systolic or > 80 mmHg diastolic and in maximum dosages of all three Beta-blockers, ACEi (ARBs) and CCB.
研究组 & 干预措施
Standard treatment
Patients with CKD 3-4, hypertension, treated for 18 months with beta-blocker and if needed ACE-inhibitor or ARB.
干预措施: Beta-blocker, ACE-inhibitor (Drug)
Intensive vasodilation
Patients with CKD 3-4 and hypertension, randomized to treatment with calcium channel blocker and if needed ACE-inhibitor or ARB for 18 months
干预措施: Calcium Channel Blockers, ACE-Inhibitor (Drug)
结局指标
主要结局
Change in glomerular filtration rate between the two treatment arms.
时间窗: Measured at baseline and after 18 months of treatment
次要结局
- Changes in glomerular filtration rate stratified after changes in pulse wave velocity, renal vascular resistance and forearm minimal resistance at baseline and after 18 months of treatment.(18 months)