Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism

NCT ID: NCT00520247

Last Updated: 2007-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 443 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-02-28

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.

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.

Conditions

Plasma Total Homocysteine Level; Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

enalapril plus folic acid

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 Type: DRUG

Eligibility 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

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

Harbin Medical University

OTHER

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Nanjing Medical University

OTHER

Sponsor Role: collaborator

Anhui Medical University

OTHER

Sponsor Role: lead

Principal Investigators

Ping Liu, Dr.

Role: STUDY_DIRECTOR

Peking University First Hopital

Locations

Inistitute for Biomedicine, Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

2005L01101

Identifier Type: -

Identifier Source: org_study_id