MTHFR C677C/T Genotype-Guided Folic Acid Combined with Vitamin B12 Adjuvant to Different Antihypertensive Regimens: Efficacy and Mechanism in MHD Patients with Hypertension and Coronary Heart Disease

A single-case randomized controlled study on the guidance of MTHFR 677C/T gene in folate metabolism for the combined use of folate with vitamin B12 as an adjuvant to amlodipine besylate, atorvastatin, felodipine sustained-release tablets, and enalapril maleate-folate tablets in patients with hemodialysis complicated by hypertension and coronary heart disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500112318

Enrollment

Unknown

Registered

2025-11-12

Start date

2025-11-20

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension and Coronary Heart Disease in

Interventions

A1:Amlodipine Besylate Tablets (5mg per dose, once daily) and Atorvastatin Calcium Tablets (20mg per dose, once daily)

A2:Amlodipine Besylate Tablets (5mg per dose, once daily) and Atorvastatin Calcium Tablets (20mg per dose, once daily), Folic Acid Tablets (15mg per day), and Vitamin B12 Tablets (500µg per dose, twic

B1:Felodipine Extended-Release Tablets (2.5~5.0mg per dose, once daily) and Enalapril Maleate and Folic Acid Tablets (10mg Enalapril + 0.8mg Folic Acid per dose, once daily)

B2:Felodipine Extended-Release Tablets (2.5~5.0mg per dose, once daily) and Enalapril Maleate and Folic Acid Tablets (10mg Enalapril + 0.8mg Folic Acid per dose, once daily).Folic Acid Tablets (15mg p

Eligibility

Sex/Gender

All

Age

25 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. MHD duration >= 6 months, with a stable dialysis regimen (three times per week, each session 4.5~5 hours, low-flux dialyzer, blood flow rate 250~300 mL/min, urea clearance index Kt/V >= 1.2); 2. HTN in accordance with the 2023 Chinese Guidelines for Prevention and Treatment of Hypertension: systolic blood pressure (SBP) >=140 mmHg and/or diastolic blood pressure (DBP)>= 90 mmHg before dialysis, persisting for >= 2 weeks; 3. CHD in accordance with the 2020 Guidelines for Diagnosis and Treatment of Stable Coronary Heart Disease: confirmed by coronary angiography with at least one coronary artery stenosis >= 50%, or history of previous myocardial infarction/coronary stent implantation; 4. Age 18~75 years, with life expectancy >= 1 year.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Acute infection, thrombosis, bleeding, or acute myocardial infarction/heart failure within the past 3 months; 2. Malignant tumors, diabetes mellitus (hemoglobin A1c >=7.0%), severe anemia (hemoglobin <90g/L); 3. Allergy to folic acid, vitamin B12, or the test drugs (amlodipine, felodipine, enalapril, atorvastatin); 4. Use of drugs affecting homocysteine (such as methotrexate, oral contraceptives) within the past month.

Design outcomes

Primary

Measure	Time frame
Blood Press;24h SBP-ARV;24h SBP-SD;	—

Secondary

Measure	Time frame
Hcy;BUN;	—

Countries

China

Contacts

Public ContactLiu Wei

Jiaozuo People's Hospital Molecular Laboratory

liuwei000873@163.com+86 155 3891 6798

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026