Effect of Aliskiren 300mg and Hydrochlorothiazide 25mg on Kidney Oxygenation in Patients With Stage 1 and 2 Hypertension: a BOLD-MRI Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Renal Oxygenation Changes After Chronic Treatment With Aliskiren or Hydrochlorothiazide
研究概览
简要总结
The goal of this project is to evaluate the chronic effect (8 weeks) of RASILEZ 300mg (aliskiren) on renal tissue oxygenation in patients with stage 1-2 hypertension, and to compare the chronic effect (8 weeks) of RASILEZ 300mg (aliskiren) on renal tissue oxygenation in patients with stage 1-2 hypertension with these effects with those of ESIDREX 25mg (hydrochlorothiazide).
详细描述
36 patients with arterial hypertension stage 1-2 (blood pressure: 140/90 and 180/110 mm Hg) will be included in this study and randomized to two groups of 18 patients each: one group will receive RASILEZ 300mg (aliskiren) and one group ESIDREX 25mg (hydrochlorothiazide).
After a two week washout of antihypertensive drugs, baseline and the chronic effect (8 week study drug) of each group will be studied with precise renal hemodynamic measurements (inulin clearance, PAH renal plasma and blood flow, sodium and endogenous lithium excretion, plasma renin, plasma aldosterone, urinary sodium and potassium) and assessment of renal oxygenation with BOLD-MRI (blood oxygen level detection - magnetic resonance imaging).
Drug therapy will be started with an initial 2 weeks on Rasilez 150 mg or HCTZ 12.5 mg followed by a titration to 300 mg Rasilez and 25 mg HCTZ if the treatment is well tolerated. In both groups: a first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
Patients already on treatment with antihypertensive drugs can be included in this study, but will undergo a 'wash-out' period of two weeks. After obtaining informed consent, baseline physical examination and office blood pressure measurement will be performed. Office blood pressure will be measured according to the guidelines of the European Society on Hypertension and European Society of Cardiology (ESH-ESC practice guidelines) by an experienced physician. Moreover, patients will measure their home blood pressure twice daily: after 5 minutes of sitting quietly, three measures spaced by 1-2 minutes will be taken in the morning and in the evening. For this purpose, an Omron 705 IT device will be provided to the participants; this device has been widely tested in clinical practice and has been validated for use in clinical studies (12).
Throughout the study, the participants will continue his/her regular diet. The goal should be to keep the salt intake as stable as possible during the study, since salt intake alters the R2* signal. Salt intake will be verified each time before BOLD-MRI measurement by a 24h urine collection (dosing volume, creatinine- and sodium-concentration).
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
- 是
入选标准
- •Tolerance to study drugs
- •Age > 18 years
- •Arteria hypertension stage 1-2 (blood pressure: 140/90 and 180/110 mm Hg)
- •Normal renal function
- •Availability to give informed consent
排除标准
- •Intolerance to study drugs
- •Renal artery stenosis
- •Hyperkalaemia > 5.0 mmol/l
- •Contra-indications to the use of PAH, inulin or Lithium
- •Pychiatric illness
- •No estimated easy vascular venous access for placement of two peripherical venous catheters in forearms
- •Contra-indication to MRI-imaging: Claustrophobia or Pacemaker or other implanted metal device
研究组 & 干预措施
Aliskiren
Aliskiren 150 to 300 mg once a Week for 8 weeks
干预措施: Aliskiren (Drug)
Hydrochlorothiazide
HCTZ 12.5 - 25 mg/d once a day for 8 weeks
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Renal Oxygenation Changes After Chronic Treatment With Aliskiren or Hydrochlorothiazide
时间窗: week 0 vs week 8
Changes in R2\* at between week 0 and week 8 as measured by BOLD MRI in the cortex and medulla of the kidney
次要结局
未报告次要终点
研究者
Michel Burnier
Professor
Centre Hospitalier Universitaire Vaudois
