RAS Blockade at Bedtime Versus on Awakening for the Prevention of Aldosterone Breakthrough
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Serum aldosterone levels at one year
研究概览
简要总结
Objective:
To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.
Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.
Main selection criteria:
Inclusion criteria
- Chronic kidney disease stage 3 to 4,
- ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
- History of hypertension or proteinuria > 0,5 g/24h or g/g créatininurie.
Exclusion criteria
- Office blood pressure ≥ 160/100 mmHg,
- Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.
Evaluation criteria:
Primary: Serum aldosterone levels at one year.
Secondary:
- Serum aldosterone/renin ratio,
- 24h urine aldosterone,
- Significant aldosterone breakthrough defined by a >10% increase of serum aldosterone levels over baseline values,
- Aldosterone breakthrough defined by an increase of serum aldosterone levels over baseline values,
- HbA1c,
- Urinary albumin/creatinine ratio (UACR) on spot morning urine samples,
- Systolic home blood pressure (SBP),
- Estimated glomerular filtration rate (eGFR) using the MDRD equation.
详细描述
Rational:
Serum aldosterone levels may increase despite blockade of the renin angiotensin system (RAS) with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). This aldosterone breakthrough might be associated with bad outcomes: left ventricular hypertrophy, proteinuria and progression of renal failure. Antihypertensive drugs are given either on awaking or at bedtime. RAS is stimulated during nighttime. RAS blockers and diuretics given on awaking may stimulate aldosterone synthesis, and favor aldosterone breakthrough.
Objective:
To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.
Duration of the study: Inclusion 2 years, follow-up one year, total 3 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Chronic kidney disease stage 3 to 4,
- •ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
- •History of hypertension or proteinuria > 0,5 g/24h or g/g creatininuria,
- •Adult with social security insurance,
- •Informed consent signed.
排除标准
- •Office blood pressure ≥ 160/100 mmHg,
- •Pathology with life expectancy < 1 year,
- •Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.
结局指标
主要结局
Serum aldosterone levels at one year
时间窗: Level change between baseline and one year
次要结局
- Significant aldosterone breakthrough Significant aldosterone breakthrough(changes between baseline and one year)
- Serum aldosterone/renin ratio(level change between baseline and 12 months)