Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anhui Medical University
• Collaborators: China Medical University Hospital; First Affiliated Hospital Xi'an Jiaotong University; Harbin Medical University; Huashan Hospital; Nanjing Medical University; Peking University First Hospital
• Treatments: Enalapril; Enalaprilat; Folic Acid; Vitamin B Complex

Criteria

Inclusion Criteria:

• Age≥18 years and less than 75 years

• Essential hypertension patients

• Sedentary systolic blood pressure≥140mmHg and less than 180mmHg, and/or sedentary diastolic blood pressure≥90mmHg and less than 110mmHg

• Reproductive women agree to take a reliable contraception measure during the trial

• Written informed consent

Exclusion Criteria:

• Pregnant women

• Women within lactateion period

• Hypersensitive to angiotensin-converting enzyme inhibitor (ACEI) or folic acid

• Easily hypersensitiveness

• Diagnosed secondum hypertension or skeptical secondum hypertension

• Severe hypertension (sedentary systolic blood pressure≥180mmHg and/or sedentary diastoleic blood pressure≥110mmHg)

Severe diseases:

• Cardiovascular system:

• Diagnosed cardia insufficiency (NYHAⅢ 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 Ⅱ, atrioventricular block above Ⅱ level, et al

• Alimentary system:

• 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)>30g/L

• Stomach bulk resect and gastrojejunostomy, stomach intestine malabsorption

• Urinary system:

• Serum creatinine≥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≥11.1mmol/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, et al

• Taking other antihypertensive drugs

• Taking folic acid or other Vitamin B groups