Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism

Sponsor

Anhui Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT00520247

Collaborator

Peking University First Hospital (Other), Huashan Hospital (Other), Harbin Medical University (Other), China Medical University Hospital (Other), First Affiliated Hospital Xi'an Jiaotong University (Other), Nanjing Medical University (Other)

443

Enrollment

Location

Duration (Months)

88.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Plasma Total Homocysteine Level Blood Pressure	Drug: enalapril plus folic acid	Phase 2

Detailed Description

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 greater than or equal to 180 mmHg and/or sedentary diastoleic blood pressure greater than or equal to 110 mmHg)
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.

Taking other antihypertensive drugs
Taking folic acid or other Vitamin B groups

Primary Outcome Measures:

Blood pressure of study participants was measured at baseline, 2th week, 4th week, 6th week and at the end of trial
Subjects' plasma total homocysteine concentration were measured at baseline, 4th week and at 8th week.

Secondary Outcome Measures:

Participants' living habit and life style were collected at baseline with the original questionnaires.
A follow up questionnaire was sent out at 2th week, 4th week, 6th week and at the end of the trial.

Study Design

Study Type:

Interventional

Actual Enrollment :

443 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Antihypertensive and Plasma Total Homocysteine Lowering Combined Therapy With Enalapril and Folic Acid in Hypertensive Patients:A Multicenter Double Blind Randomized Clinical Trial

Study Start Date :

Sep 1, 2005

Actual Study Completion Date :

Feb 1, 2006

Outcome Measures

Primary Outcome Measures

Blood pressure of study participants was measured at baseline, 2th week, 4th week, 6th week and at the end of trial Subjects' plasma total homocysteine concentration were measured at baseline, 4th week and at 8th week. [8 weeks]

Secondary Outcome Measures

Participants' living habit and life style were collected at baseline with the original questionnaires. A follow up questionnaire was sent out at 2th week, 4th week, 6th week and at the end of the trial. [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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