Enalapril Maleate and Folic Acid Tablets for Prevention of Chronic Kidney Diseases in Patients With Hypertension: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Renal function decline
研究概览
简要总结
The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing renal function decline among the patients with primary hypertension when compared to enalapril maleate.
详细描述
Elevated blood concentration of homocysteine (Hcy) has been suggested as a modifiable, independent risk factor for coronary artery disease, stroke, and deep vein thrombosis. Prevalence of hyperhomocysteinemia and folic acid deficiency in China are significantly higher than those in Europe and USA. The investigators' preliminary research demonstrated that blood concentration of Hcy was negatively correlated to estimated glomerular filtration rate (eGFR), a key index of kidney function. However, the question as to whether Hcy-lowering therapy with folic acid can reduce the risk of chronic kidney disease(CKD) remains to be answered.
This study, exploiting the hypertensive population of CSPPT trial (ClinicalTrials.gov register number: NCT00794885), is intended to compare the effects of enalapril maleate and folic acid tablets versus enalapril maleate in preventing renal function decline among the patients with primary hypertension. The results from this trial may have the potential to transform current clinical and public health findings into practice in the prevention of chronic kidney disease(CKD) in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment;
- •45-75 years old;
- •Successful determination of methylenetetrahydrofolate reductase (MTHFR) C677T genotype;
- •For pre-menopausal women, agreed to use contraceptives during the trial;
- •Signed the written informed consent.
排除标准
- •Having a history of stroke;
- •Having a history of myocardial infarction;
- •Having a history of physician diagnosed heart failure;
- •Post- coronary revascularization;
- •Severe somatic disease such as cancer;
- •Secondary hypertension;
- •Congenital or acquired organic heart diseases;
- •Contraindicated to angiotensin-converting enzyme inhibitor (ACEI);
- •Having a history of ACEI adverse effects;
- •Currently long-term use of folic acid or vitamin B12 or vitamin B6;
- •Pregnant or child breastfeeding women;
- •Severe mental disorders;
- •Lab tests indicating abnormal liver or kidney function;
- •Unwilling to participate the trial;
- •Unwilling to change the current antihypertensive treatment.
研究组 & 干预措施
Enalapril maleate and folic acid tablets
A fixed combination drug is given. The dose is fixed in enalapril 10 mg / folic acid 0.8 mg per day.
干预措施: Enalapril maleate and folic acid tablets (Drug)
Enalapril maleate
Enalapril maleate 10 mg per day is given
干预措施: Enalapril maleate (Drug)
结局指标
主要结局
Renal function decline
时间窗: Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.
Renal function decline was defined based on one of more of the following : (1) A certain drop in eGFR, was defined as a drop in GFR category (≥90\[G1\], 60-89\[G2\], 45-59\[G3a\], 30-44\[G3b\], 15-29\[G4\], \<15\[G5\] ml/min/1.73m2) accompanied by a 25% or greater drop in eGFR from baseline; (2) Rapid progression, was defined as a sustained decline in eGFR of more than 5 ml/min/1.73m2/yr.
次要结局
- A composite of renal events.(Every 3 months during the trial, up to 5 years)
- Average decline rate in eGFR (ml/min/1.73m2/yr).(Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.)
- New-onset chronic kidney disease based on eGFR（eGFR<60 ml/min/1.73 m2）(Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.)
- New-onset albuminuria(Albuminuria was examined at baseline and at the final visit (5 years) of the trial.)