Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism
Condition: Plasma Total Homocysteine Level; Blood Pressure
Study type: Interventional
Phase: Phase 2

Summary: 
      Combinded therapy with folic acid and enalapril may significantly decrease plasma total
      homocysteine level and had beneficial effect on blood pressure reduction and glycometabolism.
    

Detailed description: 
      Inclusion Criteria:

        1. Age≥18 years and less than 75 years

        2. Essential hypertension patients

        3. Sedentary systolic blood pressure≥140mmHg and less than 180mmHg, and/or sedentary
           diastolic blood pressure≥90mmHg and less than 110mmHg

        4. Reproductive women agree to take a reliable contraception measure during the trial

        5. Written informed consent

      Exclusion Criteria:

        1. Pregnant women

        2. Women within lactateion period

        3. Hypersensitive to Angiotensin-Converting Enzyme Inhibitor (ACEI) or folic acid

        4. Easily hypersensitiveness

        5. Diagnosed secondum hypertension or skeptical secondum hypertension

        6. Severe hypertension (sedentary systolic blood pressure greater than or equal to 180 mmHg
           and/or sedentary diastoleic blood pressure greater than or equal to 110 mmHg)

        7. Severe diseases:

             -  Cardiovascular system

             -  Diagnosed cardia insufficiency (New York Health Association [NYHA] III level and
                higher)

             -  Hypertrophic obstructive cardiomyopathy (HOCM)

             -  Clinical significantly Valvular Disease of the Heart (VDH)

             -  Acute coronary syndrome or coronary artery interventional therapy or coronary
                artery bypass graft within three months

             -  Severe arrhythmia such as atrial flutter, atrial fibrillation, ventricular
                arrhythmia above Lown ?, atrioventricular block above II level, etc.

             -  Alimentary system disorders

             -  Active virus hepatitis

             -  Any of alanine aminotransferase (ALT), aspartate aminotransferase (AST),
                galactosylhydroxylysyl glucosyltransferase (GGT), alkaline phosphatase (ALP), total
                bilirubin (TBIL), Direct Bilirubin (DB) was above 2 times of it's normal value
                upper limit, albumin (ALB) greater than 30 g/L

             -  Stomach bulk resect and gastrojejunostomy, stomach intestine malabsorption

           Urinary system:

             -  Serum creatinine greater than or equal to 200 mmol/L

             -  Diagnosed stenosis of renal artery, solitary kidney

             -  Renal transplantation

           Endocrine system:

             -  Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (fasting glucose
                greater than or equal to 11.1 mmol/L)

             -  Diagnosed and uncontrolled hyperthyrosis

           Respiratory system:

             -  Chronic cough nervous or psyche system:

             -  Transient Ischemia Attach (TIA) or stoke within 3 months

             -  Severe peripheral nerve or vegetative nerve functional disturbance

             -  Psyche or nervous system dysfunction

             -  Drugs or alcohol dependence

           Others:

             -  Malignant tumor

             -  Malnutrition, haematogenesis dysfunction, etc.

        8. Taking other antihypertensive drugs

        9. Taking folic acid or other Vitamin B groups

      Primary Outcome Measures:

        1. Blood pressure of study participants was measured at baseline, 2th week, 4th week, 6th
           week and at the end of trial

        2. Subjects' plasma total homocysteine concentration were measured at baseline, 4th week
           and at 8th week.

      Secondary Outcome Measures:

        1. Participants' living habit and life style were collected at baseline with the original
           questionnaires.

        2. A follow up questionnaire was sent out at 2th week, 4th week, 6th week and at the end of
           the trial.
    

Intervention name(s): enalapril plus folic acid
Intervention type(s): Drug
Intervention description(s): enalapril 10.0 mg daily for 8 weeks (the control group); enalapril 10.0 mg plus folic acid 0.4 mg daily for 8 weeks (Low-dose group); enalapril 10.0 mg plus folic acid 0.8 mg daily for 8 weeks (High-dose group)
Intervention MeSH terms: Folic Acid; Enalapril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: enalapril; folic acid; hyperglycemia; hypertension; fasting plasma glucose