This is a multicenter, randomized, double-blind, controlled clinical trial. It aims to investigate the effects of different doses of folic acid on lowering homocysteine (Hcy) in patients with hypertension with different genotypes of MTHFR C677T and to determine a dose-response relationship. This study consists of 3 phases: screening ( 2-10 days ), run-in period (0-2 weeks), and double-blind treatment (8 weeks). Follow-up visits will take place at the beginning of both the run-in period and the double-blind treatment period, and at the end of the 2nd, 4th, 6th, and 8th weeks. Hypertensive patients demonstrating good tolerance and adherence to angiotensin converting enzyme inhibitor (ACEI) drugs and who have already been genotyped for MTHFR C677T polymorphism may pass over the run-in period and directly enter the double-blind randomized treatment period. No medications that could affect the assessment of efficacy may be taken during any stage of the study.
Name: Folic Acid
Name: Enalapril Maleate and Folic Acid Tablets (Yiye)
Name: Enalapril
Description: Hcy percent decrease =(baseline Hcy - end Hcy) /baseline Hcy *100%
Measure: Percentage decrease in blood homocysteine levels by the end of the 8th week from baseline. Time: by the end of the 8th week from the baselineDescription: Absolute Hcy reduction (μmol/L) = baseline Hcy - end Hcy
Measure: Magnitude of decrease in blood homocysteine by the end of the 8th week from baseline. Time: by the end of the 8th week from the baselineDescription: Folate increase rate=(end folate- baseline folate)/baseline folate *100% folate increase magnitude= end folate - baseline folate
Measure: Percentage of increase in blood folate levels by the end of the 8th week from baseline. Time: by the end of the 8th week from the baselineDescription: Absolute folate reduction (μmol/L)= baseline folate - end folate
Measure: Magnitude of increase in blood folate levels by the end of the 8th week from baseline. Time: by the end of the 8th week from the baselineAllocation: Randomized
Parallel Assignment
There is one SNP
A Randomized, Double-Blind, Controlled Trial on the Homocysteine-Lowering Effects of Different Doses of Folic Acid Among Patients With Hypertension According to Methylenetetrahydrofolate Reductase C677T Genotypes. --- C677T ---
It aims to investigate the effects of different doses of folic acid on lowering homocysteine (Hcy) in patients with hypertension with different genotypes of MTHFR C677T and to determine a dose-response relationship. --- C677T ---
Hypertensive patients demonstrating good tolerance and adherence to angiotensin converting enzyme inhibitor (ACEI) drugs and who have already been genotyped for MTHFR C677T polymorphism may pass over the run-in period and directly enter the double-blind randomized treatment period. --- C677T ---
Inclusion Criteria for Double-Blind Treatment Period: - (1)Completed MTHFR C677T gene polymorphism detection in run-in period or MTHFR C677T genotype already known in advance; - (2)Exhibited good tolerance to enalapril and good overall medication compliance (>80%) in run-in period or previously exhibited good tolerance and adherence to ACEI drugs in previous medication history. --- C677T ---
Inclusion Criteria for Double-Blind Treatment Period: - (1)Completed MTHFR C677T gene polymorphism detection in run-in period or MTHFR C677T genotype already known in advance; - (2)Exhibited good tolerance to enalapril and good overall medication compliance (>80%) in run-in period or previously exhibited good tolerance and adherence to ACEI drugs in previous medication history. --- C677T --- --- C677T ---
MTHFR C677T genotype will also be determined during this phase. --- C677T ---
Hypertensive patients demonstrating good tolerance and adherence to angiotensin converting enzyme inhibitor (ACEI) drugs and who have already been genotyped for MTHFR C677T polymorphism may pass over the run-in period and directly enter the double-blind randomized treatment period. --- C677T ---
Patients who remain eligible for participation in the study will first be stratified by gender and MTHFR C677T genotype (CC, CT, TT), for a total of 6 strata at the start of V2. --- C677T ---
For participants who complete the run-in period and are eligible to remain in the study, a randomized treatment allocation list will be generated using a stratified, block-wise, randomized approach by MTHFR C677T genotype and gender. --- C677T ---