Essential Hypertension
Conditions
Interventions
Control group:Amlodipine folic acid tablets 5.8 mg/tablet (5 mg amlodipine + 0.8 mg folic acid) ,taken orally, once daily.
Test group:Amlodipine folic acid tablets 5.8 mg/tablet + 5-methyltetrahydrofolate 0.4 mg ,taken orally, once daily.
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1: Men and women, aged >= 35 and = 140 mmHg and/or DBP >= 90 mmHg (average of at least 2 measurements each time) at two separate (not on the same day) clinical; 3: MTHFR 677 TT genotype (based on the test results from the central laboratory during the screening period or a previous official test report from a laboratory with medical testing; 4: Voluntarily participates and has given signed informed consent.
Exclusion criteria
Exclusion criteria: 1: Previously diagnosed secondary hypertension; 2: Previously diagnosed stroke; 3: Previously diagnosed myocardial infarction; 4: Previously diagnosed heart failure; 5: Known to have congenital (such as aortic stenosis) or acquired organic heart disease; 6: Known to have any of the following severe diseases or conditions: a.Digestive system: i. Previously diagnosed with any form of viral hepatitis that is currently still in the active phase; ii. Abnormal liver function test before enrollment (any of ALT, AST, GGT, TBIL, DBIL test 3 times higher than normal, or ALB <= 30g/L); iii. Subtotal gastrectomy and/or gastrojejunostomy; b.Respiratory system: previously diagnosed with pulmonary heart disease; c.Presence of malignant tumors or other severe diseases; d.Presence of long-term gastrointestinal symptoms such as sitophobia, nausea, and bloating; e.Previously diagnosed with vitamin B12 deficiency and/or its related diseases. 7: Participant, at the investigator's discretion, is assessed to be unsuitable for the study, for reasons including but not limited to the presence of abnormal laboratory results, or clinical conditions; 8: Prior history of significant intolerance due to adverse reactions resulting from usage of amlodipine or other CCBs, or any drugs or health products containing folate or folic acid; 9: Regular consumption of folic acid or vitamin B compounds, or other compounds containing folic acid in the past 3 months; 10: The presence of any of the following conditions that could negatively influence a participant's ability to consent or participate in the trial:Dementia;Severe mental disorders; Inability to express informed consent;Unlikely to complete the study follow-up as specified by the protocol, or plans to relocate outside of the study area in the near future;History of poor compliance when taking antihypertensive medications or is expected to have poor compliance 11: Refusal to participate, or inability to modify current drug regimen; 12: Women who are pregnant or breastfeeding; or women of childbearing age who are unwilling to use effective contraception during the trial period; 13: Within one month of the first visit, participating in any clinical trial for any drug that has yet to be officially approved by the state and is not currently approved for sale, or currently participating in any clinical trial that could potentially impact the results of this study (medication use, drug efficacy, drug interaction, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in plasma Hcy level (µmol/L) from baseline after 8 weeks of treatment: Percentage reduction in Hcy = (baseline Hcy - Hcy after 8 weeks)/baseline Hcy × 100%.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Magnitude and percent increase in serum 5-methyltetrahydrofolate from baseline after 8 weeks of treatment;Reduction in blood pressure from baseline after 8 weeks of treatment (baseline blood pressure value - blood pressure value after 8 weeks);Magnitude and percentage increase in serum total folate from baseline after 8 weeks of treatment;Magnitude of reduction in plasma Hcy levels from baseline after 8 weeks of treatment (baseline Hcy - Hcy after 8 weeks); | — |
Countries
China
Contacts
Public ContactJianping Li
Peking University First Hospital
Outcome results
None listed