Hypertension Clinical Trial
Official title:
Enalapril Maleate and Folic Acid Tablets for Prevention of Chronic Kidney Diseases in Patients With Hypertension: a Double-blind Randomized Controlled Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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