Efficacy of L-methylfolate and Methylcobalamine in Treating Resistant Hypertension Associated with Elevated Serum Homocysteine in Hemodialysis Patients.

Phase 4

Completed

• Conditions: Hypertension, Renal; End Stage Renal Disease
• Interventions: Drug: L-Methyl Folate and methylcobalamine

• Registration Number: NCT05807711
• Lead Sponsor: Alexandria University

Brief Summary

The aim of the study is to evaluate the efficacy of L-methylfolate in combination with methylcobalamine in reducing homocysteine blood levels in hypertensive end-stage renal disease patients on regular hemodialysis and its association with blood pressure control in treatment of resistant hypertension

Detailed Description

1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University

2. Agreement from all participants should be taken in this clinical study by assigning an informed consent

3. Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension will be recruited from hemodialysis unit in Alexandria University Hospitals

4. Patients will be screened for resistant hypertension as determined by the mean of mid-week pre-dialysis BP \> 140/90 mm Hg, post-dialysis BP \> 130/80 mm Hg over a period of one month.

5. A blood sample will be collected for homocysteine measurement at baseline

6. Patients will be randomized using simple randomization technique via computer based program to take one tablet daily containing L-methylfolate and methylcobalamine or no treatment.

7. Patients will be followed over a period of 3 months after which blood pressure measurement and blood sampling would be repeated and compared to baseline values

8. As a measurement of the prognosis of elevated homocysteine, we should follow the development of myocardial infarction, stroke and cardiovascular events for 3 months

9. The appropriate statistical tests will be held according to the study design and parameters to evaluate the significance of the results

10. Results, conclusion, discussion and recommendations will be given

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Study Start: 2023-04-01
• Study First Posted: 2023-04-11
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP > 140/90 mm Hg, post-dialysis BP > 130/80 mm Hg despite the use of three or more drugs

Exclusion Criteria

• Age > 75 years
• Excessive use of alcohol or smoking
• Severe hepatic impairment
• Acute kidney injury on top of chronic kidney disease
• Pregnant females
• Allergy or intolerance to any component of the formulation
• Medication side effects (methotrexate, theophylline, phenytoin, and cyclosporine) or any drug proven to cause hyperhomocysteinemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Intervention group	L-Methyl Folate and methylcobalamine	Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP \> 140/90 mm Hg, post-dialysis BP \> 130/80 mm Hg despite the use of three or more drugs. Patients will be assigned to take one tablet daily containing L-methylfolate and methylcobalamine. Patients will be followed over a period of 3 months after which blood pressure measurement and blood sampling would be repeated and compared to baseline values.

Primary Outcome Measures

Name	Time	Method
average pre-dialysis blood pressure target of ≤ 140/90 mm Hg or an average post-dialysis blood pressure target of ≤ 130/80 mm Hg	3 months	To achieve an average pre-dialysis blood pressure target of ≤ 140/90 mm Hg or an average post-dialysis blood pressure target of ≤ 130/80 mm Hg.; This should be parallel to lowering of serum homocysteine compared to baseline values

Secondary Outcome Measures

Name	Time	Method
myocardial infarction, stroke and cardiovascular events.	3 months	As a measurement of the prognosis patients will be followed up for the development of myocardial infarction, stroke and cardiovascular events for 3 months.

Trial Locations

Locations (1)

Faculty of Pharmacy, Alexandria University; 🇪🇬 Alexandria, Egypt