Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism

This study has been completed.
Sponsor:
Collaborators:
Peking University First Hospital
Fudan University
Harbin Medical University
China Medical University Hospital
Xi'an Jiaotong University First Hospital
Nanjing Medical University
Information provided by:
Anhui Medical University
ClinicalTrials.gov Identifier:
NCT00520247
First received: August 17, 2007
Last updated: August 22, 2007
Last verified: August 2007

August 17, 2007
August 22, 2007
September 2005
Not Provided
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. [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT00520247 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
 
Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism
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

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

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Plasma Total Homocysteine Level
  • Blood Pressure
Drug: 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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
443
February 2006
Not Provided

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
Both
28 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00520247
2005L01101
Yes
Not Provided
Anhui Medical University
  • Peking University First Hospital
  • Fudan University
  • Harbin Medical University
  • China Medical University Hospital
  • Xi'an Jiaotong University First Hospital
  • Nanjing Medical University
Study Director: Ping Liu, Dr. Peking University First Hopital
Anhui Medical University
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP