Clinical trial NCT00520247: Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plasma Total Homocysteine Level
Blood Pressure
Keywords: enalapril
folic acid
hyperglycemia
hypertension
fasting plasma glucose
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Huashan Hospital
name: Harbin Medical University
name: China Medical University Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Nanjing Medical University
First posted: 2007-08-23
Enrollment: 443
Sex: ALL
Minimum age (years): 28
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 8 weeks
Secondary outcomes:
measure: 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.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Inistitute for Biomedicine, Anhui Medical University
state: Anhui
Study officials:
affiliation: Peking University First Hopital
name: Ping Liu, Dr.
role: STUDY_DIRECTOR
References: